BCOD Access Dermatology – Fall 2024

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ISSUE 10 / 2024

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BCOD 3RD ANNUAL NATIONAL CONFERENCE Orlando, Florida October 27-29

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Explore Innovation in Dermatology

Please scan the code above to visit EUCRISAhcp.com and see the full Prescribing Information and Medication Guide.

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Please scan the code above to visit CIBINQOhcp.com and see Brief Summary of Prescribing Information, including BOXED WARNING, at the end of this advertisement.

Please scan the code above to visit LITFULOhcp.com and see Brief Summary of Prescribing Information, including BOXED WARNING, at the end of this advertisement.

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Helping patients unlock access and reimbursement support for Pfizer dermatology medication

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Pfizer Dermatology Patient Access (PDPA) can provide assistance throughout the coverage process, including benefits investigation, prior authorization, and the appeals process.

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No matter what type of insurance your patients have, PDPA can help identify financial support options.

Pharmacy Coordination

PDPA strives to make prescription fulfillment through the pharmacy as smooth as possible.

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You and your patients can connect with a Patient Support Representative by calling 1-833-956-DERM (1-833-956-3376), Monday-Friday, 8AM-8PM ET.

A Pfizer Field Reimbursement Manager (FRM) can support your patients enrolled in Pfizer Dermatology Patient Access by providing your office with access and reimbursement requirements. Visit PfizerDermFRM.com or scan the QR code to the right to find your local FRM.

© 2024 Pfizer Inc. All rights reserved. June 2024. PP-CIB-USA-1496

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LITFULO™ (ritlecitinib) capsules, for oral use

Brief Summary of full Prescribing Information

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS • Increased risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active TB. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test • Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase (JAK) inhibitor vs TNF blockers in rheumatoid arthritis (RA) patients. LITFULO is not approved for use in RA patients • Malignancies have occurred in patients treated with LITFULO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs TNF blockers in RA patients • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs TNF blockers in RA patients • Thrombosis has occurred in patients treated with LITFULO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs TNF blockers INDICATIONS AND USAGE LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

DOSAGE AND ADMINISTRATION Recommended Evaluations and Immunizations Prior to Treatment With LITFULO • TB infection evaluation: LITFULO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of LITFULO • Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C • Treatment with LITFULO should not be initiated in patients with absolute lymphocyte count (ALC) <500/mm3 or a platelet count <100,000/mm3 • Update immunizations according to current immunization guidelines Recommended Dosage The recommended dosage of LITFULO is 50 mg orally once daily with or without food.

LITFULO capsules should be swallowed whole; not crushed, split, or chewed.

If a dose is missed, the dose should be taken as soon as possible unless it is less than 8 hours before the next dose; in which case, skip the missed dose and resume dosing at the regular scheduled time.

Patients With Severe Hepatic Impairment LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment.

DOSAGE FORMS AND STRENGTHS Capsules: 50 mg of ritlecitinib, size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black.

CONTRAINDICATIONS LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.

WARNINGS AND PRECAUTIONS Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis. Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO. Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of serious infection or an opportunistic infection • who have resided or traveled in areas of endemic TB or mycoses, or • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LITFULO. Interrupt LITFULO if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with LITFULO should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored. LITFULO may be resumed once the infection is controlled.

Tuberculosis Screen patients for TB before starting therapy. LITFULO should not be given to patients with active TB. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk and consider screening patients at high risk for TB during treatment with LITFULO. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical trials. If a patient develops herpes zoster, consider interrupting treatment until the episode resolves.

Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with LITFULO. Patients with evidence of HIV infection or hepatitis B or C infection were excluded from clinical trials.

Mortality In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO. Malignancy and lymphoproliferative disorders, including nonmelanoma skin cancer (NMSC), were observed in clinical trials of LITFULO. In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies.

The risks and benefits of LITFULO treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than a successfully treated NMSC or cervical cancer.

Treatment Interruption or Discontinuation If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair.

Hematologic Abnormalities • Treatment with LITFULO should be discontinued if platelet count is <50,000/mm3 • Treatment with LITFULO should be interrupted if ALC is <500/mm3 and may be restarted once ALC returns above this value ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and Periodic skin examination is recommended for patients who thereafter according to routine patient management. are at increased risk for skin cancer.

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Major Adverse Cardiovascular Events In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of MACE defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue LITFULO in patients that have experienced an MI or stroke.

Thromboembolic Events An event of pulmonary embolism (PE) was reported in a patient receiving LITFULO. In a ritlecitinib higher dosing group, 1 patient reported an event of retinal artery occlusion.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, deep vein thrombosis, and PE were observed compared to those treated with TNF blockers.

Avoid LITFULO in patients who may be at increased risk of thrombosis. If symptoms of thrombosis or embolism occur, patients should interrupt LITFULO and be evaluated promptly and treated appropriately.

Hypersensitivity Serious reactions including anaphylactic reactions, urticaria, and rash have been observed in patients receiving LITFULO in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue LITFULO and institute appropriate therapy.

Laboratory Abnormalities Treatment with LITFULO was associated with decreases in lymphocytes and platelets.

Prior to LITFULO initiation, perform ALC and platelet counts. After initiating treatment with LITFULO, treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities.

Liver Enzyme Elevations: treatment with LITFULO was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times the upper limit of normal (ULN) and increases of AST ≥5 times the ULN were observed in patients in LITFULO clinical trials. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO until this diagnosis is excluded.

Creatine Phosphokinase (CPK) Elevations: treatment with LITFULO was associated with increased incidence of CPK elevation compared to placebo.

Vaccinations No data are available on the response to vaccination in patients receiving LITFULO. Use of live attenuated vaccines should be avoided during or shortly prior to initiating treatment. Prior to initiating LITFULO, it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.

ADVERSE REACTIONS Clinical Trials Experience The safety of LITFULO was evaluated in three randomized, placebo-controlled clinical trials and one long-term trial in patients with alopecia areata, including alopecia totalis and alopecia universalis, who were 12 years of age and older. A total of 1628 patients were treated with LITFULO representing 2085 patient-years of exposure. There were 1011 patients with at least 1 year of exposure to LITFULO. In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 patients were exposed to LITFULO with 130 receiving 50 mg once daily for up to 24 weeks. The median age of patients was 33 years, 105 (11.9%) patients were 12 to <18 years old and 22 (2.5%) patients were 65 years of age or older. The majority of patients were White (70.7%) and female (63.6%).

Adverse reactions occurring at ≥1% in the treated groups and at a higher rate than placebo are presented in the following table. A total of 2 (1.5%) patients treated with LITFULO 50 mg were discontinued from the trials due to adverse reactions.

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LITFULO™ (ritlecitinib) capsules, for oral use

Brief Summary of full Prescribing Information

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arch, and/or fused thoracic centra), and skeletal variations LITFULO Placebo Adverse Reactions in Clinical (delayed ossification) at 75 mg/kg/day (55 times the MRHD 50 mg based on AUC comparison). There was no developmental Trials of LITFULO for the N=213 N=130 toxicity at doses up to 25 mg/kg/day (12 times the MRHD Treatment of Alopecia Areata n (%) n (%) based on AUC comparison).

Headache 14 (10.8) 18 (8.5) In a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through Diarrhea 13 (10.0) 8 (3.8) lactation day 20 had no effects on pre- and postnatal Acne 8 (6.2) 10 (4.7) development at doses up to 75 mg/kg/day (14 times the Rash 7 (5.4) 2 (0.9) MRHD based on AUC comparison). At 175 mg/kg/day (41 times the MRHD based on AUC comparison), ritlecitinib Urticaria 6 (4.6) 3 (1.4) caused adverse lower postnatal survival and lower offspring Folliculitis 4 (3.1) 4 (1.9) body weights, which correlated with delayed sexual maturation in both sexes. Bred females in the F1 generation Pyrexia 4 (3.1) 0 also exhibited lower mean numbers of corpora lutea at Dermatitis atopic 3 (2.3) 1 (0.5) 175 mg/kg/day.

Dizziness 3 (2.3) 3 (1.4) Lactation Blood CPK increased 2 (1.5) 0 Risk Summary There are no data on the presence of ritlecitinib in human Herpes zoster 2 (1.5) 0 DRUG INTERACTIONS milk, the effects on the breastfed infant, or the effects on Effects of LITFULO on Other Drugs Red blood cell count decreased 2 (1.5) 0 milk production. Ritlecitinib is present in the milk of lactating CYP3A Substrates Stomatitis 2 (1.5) 0 rats. When a drug is present in animal milk, it is likely that Ritlecitinib is a CYP3A inhibitor. Concomitant use of it will be present in human milk. Because of the serious ritlecitinib increases area under the curve (AUC) and Cmax of adverse effects in adults, including risks of serious infection Specific Adverse Reactions CYP3A substrates, which may increase the risk of adverse and malignancy, advise women not to breastfeed during Exposure adjusted incidence rates were adjusted by clinical reactions of these substrates. treatment with LITFULO and for approximately 14 hours trial size for all adverse reactions reported in this section.

Consider additional monitoring and dosage adjustment after the last dose (approximately 6 elimination half-lives). in accordance with approved product labeling of CYP3A Data Overall Infections In the placebo-controlled trials, for up to 24 weeks, overall substrates where small concentration changes may lead After a single oral 30 mg/kg dose of ritlecitinib to lactating to serious adverse reactions when used with LITFULO. infections were reported in 66 patients (80.35 per 100 rats, ritlecitinib concentrations in milk over time were higher patient-years) treated with placebo and 43 patients (74.53 CYP1A2 Substrates per 100 patient-years) treated with LITFULO 50 mg. Across Ritlecitinib is a CYP1A2 inhibitor. Concomitant use of ritlecitinib than those in plasma. The mean milk to plasma AUC ratio was determined to be 2.2. clinical trials, including the long-term trial, overall infections increases AUC and Cmax of CYP1A2 substrates, which may were reported in 645 patients (50.71 per 100 patient-years) increase the risk of adverse reactions of these substrates. Pediatric Use treated with LITFULO 50 mg or higher.

The safety and effectiveness of LITFULO for alopecia areata Consider additional monitoring and dosage adjustment in have been established in pediatric patients ages 12 years Serious Infections accordance with the approved product labeling of CYP1A2 and older. A total of 181 pediatric patients ages 12 to <18 In the placebo-controlled trials, for up to 24 weeks, 3 patients substrates where small concentration changes may lead to years were enrolled in alopecia areata clinical trials, with 105 reported serious infections across all ritlecitinib doses serious adverse reactions when used with LITFULO. pediatric patients ages 12 to <18 years with alopecia areata studied. Across clinical trials, including the long-term trial, randomized in a pivotal, double-blind, placebo-controlled trial serious infections were reported in 12 patients (0.66 per Effects of Other Drugs on LITFULO (Trial AA-I). Efficacy was consistent between the pediatric 100 patient-years) treated with LITFULO 50 mg or higher.

CYP3A Inducers The most common serious infections were related to appendicitis, Concomitant use of strong CYP3A inducer (e.g., rifampin) patients and adults. The adverse reaction profile in the COVID-19 infection (including pneumonia), and sepsis. may decrease AUC and Cmax of ritlecitinib, which may result pediatric patients was similar to adults.

Herpes Zoster in loss of or reduced clinical response. Coadministration with The safety and efficacy of LITFULO have not been established in pediatric patients under 12 years of age.

In the placebo-controlled trials, for up to 24 weeks, herpes strong inducers of CYP3A is not recommended. zoster was reported in 4 patients across all ritlecitinib doses Geriatric Use USE IN SPECIFIC POPULATIONS studied and 0 patients treated with placebo. Across clinical No dose adjustment is required for patients ≥65 years Pregnancy trials, including the long-term trial, herpes zoster was of age.

Pregnancy Exposure Registry reported in 21 patients (1.17 per 100 patient-years) treated A total of 28 patients enrolled in alopecia areata trials were with LITFULO 50 mg or higher. Opportunistic infections of If a patient becomes pregnant while receiving LITFULO, 65 years of age and older, and none were 75 years of age multi-dermatomal herpes zoster were reported in 1 patient healthcare providers should report LITFULO exposure by and older. Clinical trials of LITFULO did not include sufficient (0.50 per 100 patient-years) treated with the ritlecitinib calling 1-877-390-2940. numbers of patients 65 years of age and older to determine higher dose in the placebo-controlled trials and 2 patients Risk Summary whether they respond differently from younger adult patients.

(0.1 per 100 patient-years) treated with LITFULO 50 mg or Available data from clinical trials with LITFULO use in higher in all clinical trials.

As there is a higher incidence of infections in the elderly pregnant women are insufficient to identify a drug-associated population in general, caution should be used when treating Malignancy risk of major birth defects, miscarriage, or other adverse the elderly.

In the placebo-controlled trials, for up to 24 weeks, maternal or fetal outcomes. In animal reproduction studies, 1 malignancy (breast cancer) was reported in 1 patient Hepatic Impairment oral administration of ritlecitinib to pregnant rats and (1.33 per 100 patient-years) treated with ritlecitinib higher rabbits during organogenesis caused fetotoxicity and fetal No dose adjustment is required in patients with mild dose and no malignancy was reported in patients treated malformations at exposures equal to 49 and 55 times the (Child Pugh A) or moderate (Child Pugh B) hepatic with placebo. Across clinical trials, including the long-term maximum recommended human dose (MRHD) based on an impairment. LITFULO is not recommended in patients with trial, malignancies excluding NMSC were reported in severe (Child Pugh C) hepatic impairment.

AUC comparison, respectively.

7 patients (0.37 per 100 patient-years) treated with The background risks of major birth defects and OVERDOSAGE LITFULO 50 mg or higher. miscarriage for the indicated population are unknown.

LITFULO was administered in clinical trials up to a single Thromboembolic Events All pregnancies carry some risk of birth defects, loss, or oral dose of 800 mg. Adverse reactions were comparable Across clinical trials, including the long-term trial, PE was other adverse outcomes.

The estimated background risks to those seen at lower doses and no specific toxicities were reported in 1 patient (0.06 per 100 patient-years) treated with in the U.S. general population of major birth defects and identified. Pharmacokinetics data up to and including a single LITFULO. There was 1 report of retinal artery occlusion and miscarriages are 2-4% and 15-20% of clinically recognized oral dose of 800 mg in healthy adult volunteers indicate that 1 report of acute MI. pregnancies, respectively. more than 90% of the administered dose is expected to be Urticaria eliminated within 48 hours.

In the placebo-controlled trials, for up to 24 weeks, urticaria Data There is no specific antidote for overdose with LITFULO. Animal Data was reported in 28 patients treated in all ritlecitinib doses Treatment should be symptomatic and supportive, and studied and 3 patients treated with placebo. The rate of In an embryo-fetal development study in pregnant rats, monitor patients for signs and symptoms of adverse urticaria was 8.23 per 100 patient-years in patients treated oral administration of ritlecitinib from gestation days 6 to reactions. with LITFULO 50 mg and 4.03 per 100 patient-years in 17 decreased fetal body weights and caused fetal skeletal patients treated with placebo. Across clinical trials, including malformations (malformed vertebrae and ribs) and variations In case of an overdose, call Poison Control Center the long-term trial, urticaria was reported in 76 patients at 1-800-222-1222 for latest recommendations. (delayed ossification) at doses ≥175 mg/kg/day (49 times treated with LITFULO 50 mg or higher. Among all patients the MRHD based on AUC comparison). Maternal toxicity This brief summary is based on LITFULOTM (ritlecitinib) treated with LITFULO 50 mg or higher in the integrated safety (lower body weights) was noted at 325 mg/kg/day (102 times Prescribing Information LAB-1469-0.5. analysis, the rate of urticaria was 4.10 per 100 patient-years.

Issued: June 2023.

The median time to onset of an initial event was 8 weeks; the MRHD based on AUC comparison). There was no developmental toxicity at 75 mg/kg/day (16 times the MRHD The product’s label may have been updated. median duration of urticaria was 7 days. Most of the cases based on AUC comparison). were mild to moderate in severity.

For full Prescribing Information, visit LITFULOHCP.com.

In an embryo-fetal development study in pregnant rabbits, Decreased Lymphocyte Counts Across clinical trials, including the long-term trial, confirmed oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased ALC <500/mm3 occurred in 1 patient (<0.1%) treated with LITFULO 50 mg. Age appeared to be a risk factor for lower visceral malformations (malpositioned kidneys), skeletal © 2023 Pfizer Inc. All rights reserved.

ALC in patients ≥65 years of age. malformations (supernumerary sternebrae, absent thoracic PP-RIL-USA-0414 June 2023 Decreased Platelet Count In the placebo-controlled trials, for up to 24 weeks, treatment with LITFULO was associated with a decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which platelet count remained stable at a lower level with continued therapy. Across clinical trials, including the long-term trial, 1 patient (<0.1%) had a confirmed platelet count <100,000/mm3. No patient had a confirmed platelet count <75,000/mm3.

CPK Elevations In the placebo-controlled trials, for up to 24 weeks, events of blood CPK increased were reported in 2 (1.5%) patients treated with LITFULO 50 mg and 0 patients treated with placebo.

Liver Enzyme Elevations In the placebo-controlled trials, for up to 24 weeks, events of increases in liver enzymes ≥3 times the ULN were observed in patients treated with LITFULO.

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CIBINQO® (abrocitinib) tablets, for oral use

Brief Summary of full Prescribing Information; Initial Approval: January 2022

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS Serious Infections Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test.

• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of CIBINQO in patients with an active, serious infection including localized infections.

The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Mortality In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.

Malignancies Malignancies were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions.

In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Major Adverse Cardiovascular Events Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Thrombosis Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death.

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers.

Avoid CIBINQO in patients at risk. If symptoms of thrombosis occur, discontinue CIBINQO and treat appropriately.

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INDICATIONS AND USAGE CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

DOSAGE AND ADMINISTRATION Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation Perform the following tests and evaluations prior to CIBINQO initiation: • Tuberculosis (TB) infection evaluation – CIBINQO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of CIBINQO • Viral hepatitis screening in accordance with clinical guidelines – CIBINQO initiation is not recommended in patients with active hepatitis B or hepatitis C • A complete blood count (CBC) – CIBINQO initiation is not recommended in patients with a platelet count <150,000/mm3, an absolute lymphocyte count <500/mm3, an absolute neutrophil count <1,000/mm3, or a hemoglobin value <8 g/dL Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to CIBINQO initiation.

Recommended Dosage The recommended dose is 100 mg once daily. If an adequate response is not achieved with CIBINQO 100 mg once daily, consider increasing the dosage to 200 mg once daily.

Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily.

Use the lowest efficacious dose to maintain response.

CIBINQO can be used with or without topical corticosteroids.

If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

Recommended Dosage in Patients with Renal Impairment or Hepatic Impairment Renal Impairment CIBINQO dosage recommendations for patients with mild renal impairment (60-89 mL/minute) is 100 mg once daily.

For patients with moderate renal impairment (30-59 mL/ minute), the recommended dosage is 50 mg once daily.

CIBINQO is not recommended for patients with severe renal impairment (15-29 mL/minute) or End-Stage Renal Disease (ESRD) (<15 mL/minute). Severe renal impairment and End-Stage Renal Disease include patients on renal replacement therapy.

In patients with mild and moderate renal impairment, if an adequate response is not achieved with initial dose, the dose of CIBINQO can be doubled.

Hepatic Impairment CIBINQO is not recommended for use in patients with severe hepatic impairment.

Recommended Dosage in CYP2C19 Poor Metabolizers In patients who are known or suspected to be CYP2C19 poor metabolizers, the recommended dosage of CIBINQO is 50 mg once daily. If an adequate response is not achieved with CIBINQO 50 mg once daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.

Dosage Modifications due to Strong Inhibitors In patients taking strong inhibitors of cytochrome P450 (CYP) 2C19, reduce the dosage to 50 mg once daily. If an adequate response is not achieved with CIBINQO 50 mg daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.

Treatment Discontinuation due to Serious Infections or Hematologic Adverse Reactions Serious or Opportunistic Infections If a patient develops a serious or opportunistic infection, discontinue CIBINQO and control the infection. The risks and benefits of treatment with CIBINQO should be carefully

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considered prior to reinitiating therapy with CIBINQO. Hematologic Abnormalities • Discontinue CIBINQO if platelet count <50,000/mm3 and follow with CBC until >100,000/mm3 • Treatment should be temporarily discontinued if ALC is less than 500 cells/mm3 and may be restarted once ALC return above this value • Treatment should be temporarily discontinued if ANC is less than 1,000 cells/mm3 and may be restarted once ANC return above this value • Treatment should be temporarily discontinued if Hb is less than 8 g/dL and may be restarted once Hb return above this value CBC evaluations are recommended at baseline, 4 weeks after treatment initiation and 4 weeks after dosage increase of CIBINQO. Laboratory evaluations may be extended for patients on chronic CIBINQO therapy who develop hematologic abnormalities.

DOSAGE FORMS AND STRENGTHS • 50 mg: Pink, oval, film-coated tablet debossed with “PFE” on one side and “ABR 50” on the other.

• 100 mg: Pink, round, film-coated tablet debossed with “PFE” on one side and “ABR 100” on the other.

• 200 mg: Pink, oval, film-coated tablet debossed with “PFE” on one side and “ABR 200” on the other.

CONTRAINDICATIONS CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.

WARNINGS AND PRECAUTIONS Serious Infections The most frequent serious infections reported in clinical studies with CIBINQO for atopic dermatitis were herpes simplex, herpes zoster, and pneumonia. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions.

Avoid use of CIBINQO in patients with active, serious infection including localized infections.

Consider the risks and benefits of treatment prior to initiating CIBINQO in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with CIBINQO. If a patient develops a serious or opportunistic infection, discontinue CIBINQO. Initiate complete diagnostic testing and appropriate antimicrobial therapy. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO. Tuberculosis Evaluate and test patients for TB before starting CIBINQO therapy and consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO. Monitor patients for the development of signs and symptoms of TB, including patients who were tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical trials with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves.

Hepatitis B virus (HBV) reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening in accordance with clinical guidelines before starting therapy and monitor for reactivation during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C. Monitor patients with inactive HBV for expression of HBV DNA during therapy with CIBINQO. If HBV DNA is detected during therapy with CIBINQO, consult a liver specialist.

Mortality In a large, randomized, postmarketing safety trial of another

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CIBINQO® (abrocitinib) tablets, for oral use Mortality (continued) JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in subjects treated with the JAK inhibitor compared with TNF blockers. CIBINQO is not approved for use in RA. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO. Malignancy and Lymphoproliferative Disorders Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials with CIBINQO for atopic dermatitis.

Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions. In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in subjects treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA. A higher rate of lymphomas was observed in subjects treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this trial, current or past smokers had an additional increased risk of overall malignancies.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Major Adverse Cardiovascular Events Major adverse cardiovascular events were reported in clinical trials of CIBINQO for atopic dermatitis.

In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Thrombosis Deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in subjects receiving CIBINQO in the clinical trials for atopic dermatitis.

Thrombosis, including DVT, PE, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death.

In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. CIBINQO is not approved for use in RA. Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and evaluate and treat patients appropriately.

Laboratory Abnormalities Hematologic Abnormalities Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a CBC. CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.

Lipid Elevations Dose-dependent increase in blood lipid parameters were reported in subjects treated with CIBINQO.

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Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Immunizations Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations.

Avoid vaccination with live vaccines immediately prior to, during and immediately after CIBINQO therapy.

ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections • Major Adverse Cardiovascular Events • Mortality • Thrombosis • Malignancy and • Laboratory Abnormalities Lymphoproliferative Disorders Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CIBINQO was evaluated in four randomized, placebo-controlled clinical trials (2 monotherapy, 1 combination therapy with topical corticosteroid, and 1 dose-ranging) and one long-term extension trial in subjects with moderate to severe atopic dermatitis (AD). A total of 1623 subjects with moderate to severe atopic dermatitis were treated with CIBINQO in these clinical trials representing 1428 patient-years of exposure. There were 634 subjects with at least 1 year of exposure to CIBINQO. In the placebo-controlled clinical trials, a total of 1198 subjects were exposed to CIBINQO with 608 subjects receiving CIBINQO 100 mg once daily and 590 subjects receiving CIBINQO 200 mg once daily for up to 16 weeks.

The median age of subjects was 33.0 years, 124 subjects (8.1%) were 12 to less than 18 years old and 94 subjects (6.1%) were 65 years of age or older. The majority of subjects were White (68.7%) and male (53.9%).

Adverse reactions occurring at ≥1% in any of the treated groups and at a higher rate than in the placebo group are presented in the table below. A total of 61 (5.1%) subjects treated with CIBINQO were discontinued from the trials due to adverse reactions. The safety profile of CIBINQO in the monotherapy and the combination trial(s) were similar.

Adverse Reactions from Placebo-Controlled Trials Reported in ≥1% of CIBINQO Treated Subjects with Moderate to Severe Atopic Dermatitis and at Higher Rate than Placebo for up to 16 Weeks Weeks 0-16 CIBINQO CIBINQO Placebo 200 mg 100 mg N=342 N=590 N=608 n (%a) a a n (% ) n (% ) Nasopharyngitis 51 (8.7) 75 (12.4) 27 (7.9) Nausea 86 (14.5) 37 (6.0) 7 (2.1) Headache 46 (7.8) 36 (6.0) 12 (3.5) Herpes simplexb 25 (4.2) 20 (3.3) 6 (1.8) Increased blood 17 (2.9) 14 (2.3) 5 (1.5) creatine phosphokinase Dizziness 17 (2.9) 11 (1.8) 3 (0.9) Urinary tract infection 13 (2.2) 10 (1.7) 4 (1.2) Fatigue 8 (1.3) 10 (1.6) 2 (0.5) Acne 28 (4.7) 10 (1.6) 0 (0.0) Vomiting 19 (3.2) 9 (1.5) 3 (0.9) Impetigo 3 (0.5) 9 (1.5) 1 (0.3) Oropharyngeal pain 6 (1.0) 8 (1.4) 2 (0.6) Hypertension 5 (0.8) 7 (1.2) 2 (0.7) Influenza 6 (1.1) 7 (1.2) 0 (0.0) Gastroenteritis 8 (1.3) 7 (1.1) 2 (0.6) Dermatitis contact 3 (0.5) 6 (1.1) 1 (0.3) Abdominal pain upper 11 (1.9) 4 (0.6) 0 (0.0) Abdominal discomfort 7 (1.2) 3 (0.5) 1 (0.3) Herpes zoster 7 (1.2) 2 (0.3) 0 (0.0) Thrombocytopenia 9 (1.5) 0 (0.0) 0 (0.0) a Study size adjusted percentages b Herpes simplex also includes oral herpes, ophthalmic herpes, herpes

dermatitis, genital herpes.

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Specific Adverse Reactions Exposure adjusted incidence rates were adjusted by trial size for all the adverse reactions reported in this section.

Overall Infections In the placebo-controlled trials, for up to 16 weeks, overall infections were reported in 90 subjects (126.8 per 100 patient-years) treated with placebo, 211 subjects (168.8 per 100 patient-years) treated with CIBINQO 100 mg and 204 subjects (159.5 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, overall infections were reported in 427 subjects (91.8 per 100 patient-years) treated with CIBINQO 100 mg and 394 subjects (103.2 per 100 patient-years) treated with CIBINQO 200 mg.

Serious Infections In the placebo-controlled trials, for up to 16 weeks, serious infections were reported in 2 subjects (2.6 per 100 patient-years) treated with placebo, 6 subjects (3.9 per 100 patient-years) treated with CIBINQO 100 mg, and 2 subjects (1.3 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, serious infections were reported in 18 subjects (2.3 per 100 patient-years) treated with CIBINQO 100 mg and 16 subjects (2.3 per 100 patient-years) treated with CIBINQO 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.

Herpes Zoster In the placebo-controlled trials, for up to 16 weeks, opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster. Herpes zoster was reported in 0 subjects treated with placebo, 3 subjects (1.9 per 100 patient-years) treated with CIBINQO 100 mg and 8 subjects (5.1 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, herpes zoster was reported in 16 subjects (2.0 per 100 patient-years) treated with CIBINQO 100 mg and 35 subjects (5.2 per 100 patient-years) treated with CIBINQO 200 mg.

Malignancy In the placebo-controlled trials, for up to 16 weeks, no malignancy was reported in subjects treated with placebo or CIBINQO 100 mg and in 1 patient (0.65 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, malignancy was reported in 4 subjects (0.5 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 200 mg.

Thrombosis In all clinical trials, including the long-term extension trial, pulmonary embolism was reported in 3 subjects (0.4 per 100 patient-years), who were treated with CIBINQO 200 mg. Deep vein thrombosis was reported in 2 subjects (0.3 per 100 patient-years) who were treated with CIBINQO 200 mg. No thrombosis occurred in subjects treated with CIBINQO 100 mg.

Major Adverse Cardiovascular Events In the placebo-controlled trials, for up to 16 weeks, major adverse cardiovascular event (MACE) was reported in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg. In all 5 clinical trials, including the long-term extension trial, MACE was reported in 1 patient (0.1 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 200 mg.

Thrombocytopenia In the placebo-controlled trials, for up to 16 weeks, treatment with CIBINQO was associated with a dose-related decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned towards baseline despite continued therapy. In all 5 clinical trials, including the long-term extension trial, 6 subjects (0.9 per 100 patient-years) treated with CIBINQO 200 mg had adverse reactions of thrombocytopenia; no subjects treated with CIBINQO 100 mg had an adverse reaction of thrombocytopenia.

Lymphopenia In the placebo-controlled trials, for up to 16 weeks, confirmed ALC <500/mm3 occurred in 2 subjects (1.2 per 100 patient-years) treated with CIBINQO 200 mg and 0 subjects treated with CIBINQO 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure.

Lipid Elevations In the placebo-controlled trials, for up to 16 weeks, there was a dose-related percent increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at Week 4 which remained elevated through the final visit in the treatment period. Adverse reactions related to hyperlipidemia occurred in 1 subject (0.6 per 100 patient-years) exposed to CIBINQO 100 mg, 3 subjects (2.0 per 100 patient-years) exposed to CIBINQO 200 mg.

Retinal Detachment In the placebo-controlled trials, for up to 16 weeks, retinal detachment occurred in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg. In all 5 clinical trials, including the long-term extension trial, retinal detachment occurred in 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 100 mg.

Creatine Phosphokinase Elevations (CPK) In the placebo-controlled trials, for up to 16 weeks, events of blood CPK increased were reported in 6 subjects (7.5 per 100 patient-years) treated with placebo, 11 subjects (6.9 per 100 patient-years) treated with 100 mg of CIBINQO and 19 subjects (12.3 per 100 patient-years) treated with 200 mg of CIBINQO. Most elevations were transient, there were no reported adverse reactions of rhabdomyolysis.

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CIBINQO® (abrocitinib) tablets, for oral use Clinical Trials Experience (continued) Pediatric Subjects (12 to less than 18 years of age) The safety of CIBINQO was assessed in a trial of 284 subjects 12 to less than 18 years of age with moderate-to-severe atopic dermatitis (Trial-AD-4). The safety profile of CIBINQO in these subjects, assessed through the initial treatment period of 12 weeks and the long-term period (213 with at least 52 weeks of abrocitinib exposure), was comparable to the safety profile from trials in adults with atopic dermatitis.

DRUG INTERACTIONS Effects of Other Drugs on CIBINQO The table below includes drugs with clinically significant drug interactions affecting CIBINQO. Clinically Significant Drug Interactions Affecting CIBINQO

Strong CYP2C19 Inhibitors Clinical Impact

Coadministration of CIBINQO with strong CYP2C19 inhibitors increases the combined exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO.

Intervention Dosage reduction of CIBINQO is recommended when coadministered with strong CYP2C19 inhibitors.

Moderate to Strong Inhibitors of both CYP2C19 and CYP2C9 Clinical Impact

Coadministration of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9 increases the exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO.

Intervention Avoid concomitant use of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9.

Strong CYP2C19 or CYP2C9 Inducers Clinical Impact

Coadministration of CIBINQO with strong CYP2C19 or CYP2C9 inducers decreases the combined exposure of abrocitinib and its two active metabolites, M1 and M2, which may result in loss of or reduced clinical response.

Intervention Avoid concomitant use of CIBINQO with strong CYP2C19 or CYP2C9 inducers.

Effects of CIBINQO on Other Drugs The table below includes clinically significant drug interactions affecting other drugs.

Clinically Significant Interactions Affecting Other Drugs P-gp Substrate Where Small Concentration Changes May Lead to Serious or Life-threatening Toxicities Clinical Coadministration of CIBINQO with P-gp Impact substrate increases plasma concentrations of P-gp substrates and may result in potential adverse reactions of the P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities (e.g., digoxin).

Intervention Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. Antiplatelet Therapy Drugs Clinical Coadministration of CIBINQO with antiplatelet Impact therapy drugs may increase the risk of bleeding with thrombocytopenia.

Intervention Antiplatelet drugs, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment are contraindicated with CIBINQO. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-3113770 or visit CIBINQOPregnancyRegistry.com.

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Risk Summary Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of abrocitinib to pregnant rats and rabbits during organogenesis at exposure 11 or 4 times the maximum recommended human dose (MRHD) based on AUC comparison, respectively, resulted in maternal dystocia and skeletal variations in rats and no adverse effects in rabbits (see Animal Data).

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively.

Animal Data In an embryofetal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, or 60 mg/ kg/day during the period of organogenesis. No fetal malformations were observed. Abrocitinib increased the incidence of skeletal variations of short 13th ribs at 30 mg/kg/day (11 times the MRHD based on AUC comparison). Increased embryofetal lethality and additional skeletal variations (cervical arches with reduced ventral processes, thickened ribs, and unossified metatarsals) were noted at 60 mg/kg/day (17 times the MRHD based on AUC comparison).

In an embryofetal development study, abrocitinib was administered orally to pregnant rabbits at doses of 10, 30, or 75 mg/kg/day during the period of organogenesis. No abrocitinibrelated maternal or developmental toxicity was noted at doses up to 75 mg/kg/day (4 times the MRHD based on AUC comparison).

In a prenatal and postnatal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, and 60 mg/kg/day beginning on gestation day 6 and continuing through lactation day 20. Dystocia with prolonged parturition and reduced offspring body weights were noted at 30 mg/kg/day (11 times the MRHD based on AUC comparison). Postnatal survival was markedly decreased at 60 mg/kg/day (17 times the MRHD based on AUC comparison). No maternal toxicity was observed at 10 mg/kg/day (2.4 times the MRHD based on AUC comparison). No abrocitinib-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring was noted at doses up to 30 mg/kg/day (11 times the MRHD based on AUC comparison).

Lactation Risk Summary There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats (see Animal Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose (approximately 5-6 elimination half-lives).

Animal Data Lactating female rats were orally administered a single dose of 10 mg/kg abrocitinib on lactation day 12.

Abrocitinib AUC was approximately 5 times greater in milk than in plasma.

Females and Males of Reproductive Potential Infertility Females Based on the findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration.

Pediatric Use The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older with atopic dermatitis have been established.

In trials Trial-AD-1 and Trial-AD-2, 124 pediatric subjects 12 to less than 18 years old weighing 25 kg or more with moderate-to-severe atopic dermatitis were enrolled and randomized to receive either CIBINQO 100 mg (N=51), 200 mg (N=48), or matching placebo (N=25) in monotherapy. Additional 284 pediatric subjects 12 to less than 18 years of age weighing 25 kg or more with moderate-to-severe atopic dermatitis, were enrolled and randomized to receive either CIBINQO 100 mg (N=95) or 200 mg (N=94) or matching placebo (N=95) in combination with topical corticosteroids in Trial-AD-4. Efficacy and adverse reaction profile were comparable between the pediatric patients and adults.

The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age.

Juvenile Animal Toxicity Data In a juvenile animal toxicity study, abrocitinib was administered orally to juvenile rats at doses of 5, 25, and 75 mg/kg/day from postnatal day 10 (approximately equivalent to a human infant) through postnatal day 63 (approximately equivalent to an adolescent). Abrocitinib caused a

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reversible, dose-related decrease in the primary spongiosa in the metaphysis of the proximal tibia and distal femur and adverse effects on bone development at all dose levels. Abrocitinib caused irreversible dose-related small or misshapen femoral heads at doses ≥5 mg/kg/day (0.8 times the MRHD based on AUC comparison); irreversibly decreased femur size and caused paw malrotation and limb impairment at doses ≥25 mg/kg/day (7.2 times the MRHD based on AUC comparison); and fractures at 75 mg/kg/day (27 times the MRHD based on AUC comparison).

In a follow-up study, abrocitinib (25 mg/kg/day, at least 4.5 times the MRHD based on AUC comparison) was orally administered to juvenile rats from postnatal day (PND) 10, 15, 21, or 30 through PND day 63. Administration beginning PND 10 caused adverse macroscopic and microscopic bone findings consistent with the previous juvenile animal study. However, administration beginning PND 15 (approximately equivalent to a 6- to 12-month old infant) caused non-adverse reversible microscopic bone findings. No bone findings were noted when administration began on PND 21 or 30 (approximately equivalent to 2- and 6-year old children, respectively).

Geriatric Use A total of 145 (4.6%) subjects 65 years of age and older, while 25 (0.8%) were 75 years of age and older, were enrolled in CIBINQO clinical trials. Clinical trials of CIBINQO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

A higher proportion of subjects 65 years of age and older discontinued from clinical trials compared to younger subjects.

Among all subjects exposed to CIBINQO, including the long-term extension trial, confirmed ALC <500/mm3 occurred only in subjects 65 years of age and older. A higher proportion of subjects 65 years of age and older had platelet counts <75,000/mm3. The incidence rate of herpes zoster in subjects 65 years of age and older treated with CIBINQO (7.40 per 100 patient-years) was higher than that of subjects 18 to less than 65 years of age (3.44 per 100 patient-years).

Renal Impairment In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30-59 mL/min) renal impairment, the combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2, is increased compared to patients with normal renal function (eGFR ≥90 mL/min). This may increase the risk of adverse reactions such as infections.

CIBINQO is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy.

A dosage reduction in patients with moderate renal impairment is recommended. No dosage adjustment is required in patients with mild renal impairment (eGFR 60-89 mL/min).

CIBINQO has not been studied in subjects on renal replacement therapy. In Phase 3 clinical trials, CIBINQO was not evaluated in subjects with atopic dermatitis with baseline creatinine clearance values less than 40 mL/min.

Hepatic Impairment Avoid use of CIBINQO in patients with severe (Child Pugh C) hepatic impairment. In clinical trials, CIBINQO was not evaluated in subjects with severe (Child Pugh C) hepatic impairment.

Dosage adjustment is not required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment based on similar combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2 compared to patients with normal hepatic function.

CYP2C19 Poor Metabolizers In patients who are CYP2C19 poor metabolizers, the AUC of abrocitinib is increased compared to CYP2C19 normal metabolizers due to reduced metabolic clearance. Dosage reduction of CIBINQO is recommended in patients who are known or suspected to be CYP2C19 poor metabolizers based on genotype or previous history/ experience with other CYP2C19 substrates.

OVERDOSAGE There is no experience regarding human overdosage with CIBINQO. There is no specific antidote for overdose with CIBINQO. In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.

Rx only This brief summary is based on CIBINQO® (abrocitinib) Prescribing Information LAB-1423-3.0.

Issued: December 2023.

The product’s label may have been updated. For full Prescribing Information, visit CIBINQOPI.com.

© 2024 Pfizer Inc. All rights reserved.

February 2024. PP-CIB-USA-1252

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contents ACCESS DERMATOLOGY | ISSUE 10

13 Founder’s Letter Advancing patient access together 14 Artificial Intelligence Ways to use AI in our field 30 Medical Science Liaison Experts provide resources and support 38 Access Management Tips to stay organized and offer high-quality care 44 Tricks of the Trade Helpful tips from BCOD members 50 Best Foot Forward How wide toe-box shoes are transforming our feet and overall health 52 From Clinic to Coordination Balancing dual roles of clinical medical assistant and biologic coordinator 56 Hidradenitis Suppurativa What is it and how can it be treated?

62 Real Talk Busy mom and content creator Megan Schinella joins new podcast “Room for Four”

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Advanced PA guidance

Resources to help patients stay on therapy

Patient education and adherence tools *Terms and conditions apply. Terms of this program may change at any time.

OPZELURA is widely available at pharmacies. Other offers and services may apply.

†

Learn more about Opzelura On Trac™ and get patients on the path to access today.

Scan the QR code or visit opzeluraontrachcp.com.

Please see Important Safety Information on the next page and Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

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INDICATIONS OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include: •

Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

•

Invasive fungal infections, including cryptococcosis and pneumocystosis.

•

Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.

Thrombocytopenia, Anemia, and Neutropenia Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA. Lipid Elevations Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions In atopic dermatitis, the most common adverse reactions (≥1%) are nasopharyngitis (3%), diarrhea (1%), bronchitis (1%), ear infection (1%), eosinophil count increased (1%), urticaria (1%), folliculitis (1%), tonsillitis (1%), and rhinorrhea (1%).

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

MALIGNANCIES

Lactation

Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Please see Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte. © 2024, Incyte. 07/24

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MAT-OPZ-02367

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OPZELURA® (ruxolitinib) cream, for topical use Brief Summary of FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE: OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions].

Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

• Invasive fungal infections, including cryptococcosis, and pneumocystosis.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.

The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA [see Warnings and Precautions].

MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions].

MALIGNANCIES Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions].

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke [see Warnings and Precautions].

THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately [see Warnings and Precautions].

WARNINGS AND PRECAUTIONS Serious Infections: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral Janus kinase inhibitors. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OPZELURA in patients: with chronic or recurrent infection; with a history of a serious or an opportunistic infection; who have been exposed to tuberculosis; who

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have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Interrupt OPZELURA if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume OPZELURA until the infection is controlled.

Tuberculosis: No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB. Viral Reactivation: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B and C: The impact of Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA on chronic viral hepatitis reactivation is unknown.

Patients with a history of hepatitis B or C infection were excluded from clinical trials.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C. Mortality: In a large, randomized, postmarketing safety study of an oral JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA. Malignancy and Lymphoproliferative Disorders: Malignancies, including lymphomas, were observed in clinical trials of oral JAK inhibitors used to treat inflammatory conditions.

Patients who are current or past smokers are at additional increased risk. Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions. In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell and squamous cell carcinoma have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

Major Adverse Cardiovascular Events (MACE): In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

Thrombosis: Thromboembolic events were observed in clinical trials with OPZELURA. Thrombosis, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. Avoid OPZELURA in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue OPZELURA and evaluate and treat patients appropriately.

Thrombocytopenia, Anemia, and Neutropenia: Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA. Lipid Elevations: Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

ADVERSE REACTIONS Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Atopic Dermatitis: In two double-blind, vehicle-controlled clinical trials

(TRuE-AD1 and TRu atopic dermatitis w group, 62% of subj and 4% were Asian and at a greater in OPZELURA (N=499) adverse event (TEAE 4 (1%) vs 0 (0%), Ea Urticaria 4 (1%) vs 0 3 (1%) vs 0 (0%), an Adverse reactions t OPZELURA group a pyrexia, seasonal acneiform dermatit Nonsegmental Vitilig TRuE-V2), 449 adu vitiligo were treated of subjects were fem Asian. The adverse ≥ 1% and at least 1% period are as follow any treatment emer 26 (6%) vs 2 (1%), 5 (2%), Headache 1 site erythema 7 (2% Adverse reactions t the OPZELURA gro hypertension, anxie dermatitis contact influenza-like illnes DRUG INTERACTI Drug interaction s known to be a sub may increase ruxo decrease ruxolitini Strong Inhibitors inhibitors of CYP3 ruxolitinib and cou USE IN SPECIFIC P Pregnancy Pregnancy Exposu outcomes in pregn persons exposed exposure by calling Risk Summary are not sufficient to other adverse mater of ruxolitinib to pre adverse developme The background populations are un other adverse outc birth defects and m Data Animal Data: Ruxolit of organogenesis, at rabbits. There were weight of approxima 60 mg/kg/day. This systemic exposure a exposure from ruxo affected body surfac lower fetal weights highest and materna approximately 70% t study in rats, preg lactation at doses embryofetal surviva function at the highe Lactation Risk Summary on the breastfed ch of lactating rats. W present in human m serious infections, breastfeed during t last dose (approxim Data: Lactating ra (30 mg/kg) on pos for up to 24 hours. the maternal plasm several of its meta

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c mycoses; or with monitor patients for ter treatment with n, an opportunistic ontrolled. clinical trials with oral Janus kinase ating patients for During OPZELURA

reactivation (e.g., inhibitors used to develops herpes resolves. reat inflammatory ation is unknown. om clinical trials. ociated elevations e been reported in RA initiation is not

n oral JAK inhibitor with at least one including sudden the JAK inhibitor e individual patient

luding lymphomas, mmatory conditions. risk. Malignancies, itors used to treat ty study of an oral on-melanoma skin ed to those treated nts treated with the ate of lung cancers compared to those had an additional s for the individual icularly in patients oma skin cancers), who are current or

ing basal cell and PZELURA. Perform wing treatment as wearing protective

zed, postmarketing der with at least one ular events (MACE) nd non-fatal stroke F blockers. Patients der the benefits and y with OPZELURA, atients with other mptoms of serious ZELURA in patients

s with OPZELURA. mbolism (PE), and inhibitors used to were serious and ty study of an oral one cardiovascular erved compared to ay be at increased ue OPZELURA and

enia, anemia, and nsider the benefits se events prior to nically indicated. If nia, anemia, and

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der widely varying g cannot be directly ot reflect the rates trolled clinical trials

(TRuE-AD1 and TRuE-AD2), 499 adult and pediatric subjects 12 years of age and older with atopic dermatitis were treated with OPZELURA twice daily for 8 weeks. In the OPZELURA group, 62% of subjects were females, and 71% of subjects were White, 23% were Black, and 4% were Asian. The adverse reactions reported by ≥ 1% of OPZELURA treated subjects and at a greater incidence than in the vehicle arm through week 8 are as follows for OPZELURA (N=499) vs Vehicle (N=250), respectively: Subjects with any treatment emergent adverse event (TEAE) 132 (27%) vs 83 (33%), Nasopharyngitis 13 (3%) vs 2 (1%), Bronchitis 4 (1%) vs 0 (0%), Ear infection 4 (1%) vs 0 (0%), Eosinophil count increased 4 (1%) vs 0 (0%), Urticaria 4 (1%) vs 0 (0%), Diarrhea 3 (1%) vs 1 (<1%), Folliculitis 3 (1%) vs 0 (0%), Tonsillitis 3 (1%) vs 0 (0%), and Rhinorrhea 3 (1%) vs 1 (<1%).

Adverse reactions that occurred in TRuE-AD1 and TRuE-AD2 in < 1% of subjects in the OPZELURA group and none in the vehicle group were: neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, Staphylococcal infection, and acneiform dermatitis.

Nonsegmental Vitiligo: In two double-blind, vehicle-controlled clinical trials (TRuE-V1 and TRuE-V2), 449 adult and pediatric subjects 12 years of age and older with nonsegmental vitiligo were treated with OPZELURA twice daily for 24 weeks. In the OPZELURA group, 55% of subjects were females, and 81% of subjects were White, 5% were Black, and 4% were Asian. The adverse reactions reported by OPZELURA treated subjects with an incidence of ≥ 1% and at least 1% greater incidence than in the vehicle arm in the 24-week double-blind period are as follows for OPZELURA (N=449) vs Vehicle (N=224), respectively: Subjects with any treatment emergent adverse event (TEAE) 214 (48%) vs 79 (35%), Application site acne 26 (6%) vs 2 (1%), Application site pruritus 23 (5%) vs 6 (3%), Nasopharyngitis 19 (4%) vs 5 (2%), Headache 17 (4%) vs 6 (3%), Urinary tract infection 7 (2%) vs 1 (<1%), Application site erythema 7 (2%) vs 1 (<1%), and Pyrexia 6 (1%) vs 0 (0%).

Adverse reactions that occurred in TRuE-V1 and TRuE-V2 in ≥ 0.5% to < 1% of subjects in the OPZELURA group and none in the vehicle group were: application site dermatitis, hypertension, anxiety, application site discoloration, application site folliculitis, contusion, dermatitis contact, diarrhea, ear infection, gastritis, gastroenteritis, hordeolum, influenza-like illness, insomnia, nasal congestion, and vomiting.

DRUG INTERACTIONS Drug interaction studies with OPZELURA have not been conducted. Ruxolitinib is known to be a substrate for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 may increase ruxolitinib systemic concentrations whereas inducers of CYP3A4 may decrease ruxolitinib systemic concentrations.

Strong Inhibitors of CYP3A4: Avoid concomitant use of OPZELURA with strong inhibitors of CYP3A4 as there is a potential to increase the systemic exposure of ruxolitinib and could increase the risk of OPZELURA adverse reactions.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Exposure Registry: There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

Risk Summary: Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity.

The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The background risk in the U.S. general population of major birth defects and miscarriage is 2-4% and 15-20%, respectively.

Data Animal Data: Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30, or 60 mg/kg/day in rats and 10, 30, or 60 mg/kg/day in rabbits. There were no treatment-related malformations at any dose. A decrease in fetal weight of approximately 9% was noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose resulted in systemic exposure approximately 22 times the clinical systemic exposure at the maximum recommended human dose (MRHD; the clinical systemic exposure from ruxolitinib cream, 1.5% applied twice daily to 25-40% atopic dermatitisaffected body surface area is used for calculation of multiples of human exposure). In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose resulted in systemic exposure approximately 70% the MRHD clinical systemic exposure. In a pre-and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse effects on embryofetal survival, postnatal growth, development parameters or offspring reproductive function at the highest dose evaluated (3.1 times the MRHD clinical systemic exposure).

Lactation Risk Summary: There are no data on the presence of ruxolitinib in human milk, the effects on the breastfed child, or the effects on milk production. Ruxolitinib was present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Data: Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13 times the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma.

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Pediatric Use: Atopic Dermatitis: The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from TRuE-AD1 and TRuE-AD2, which included 92 pediatric subjects aged 12 to 17 years with mild-to-moderate atopic dermatitis. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established.

Nonsegmental Vitiligo: The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from TRuE-V1 and TRuE-V2, which included 55 pediatric subjects aged 12 to 17 years with nonsegmental vitiligo. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established.

Juvenile Animal Toxicity Data: Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at systemic exposures that are at least 40% the MRHD clinical systemic exposure.

Geriatric Use: Of the 1249 total subjects with atopic dermatitis in clinical trials with OPZELURA, 115 (9%) were 65 years of age and older. No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

Of the 831 total subjects enrolled with nonsegmental vitiligo in clinical trials with OPZELURA, 65 (8%) were 65 years of age and older. Clinical trials of OPZELURA in subjects with nonsegmental vitiligo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

PATIENT COUNSELING INFORMATION Advise the patient or caregivers to read the FDA-approved patient labeling (Medication Guide).

Infections: Inform patients that they may be at increased risk for developing infections, including serious infections, when taking Janus kinase inhibitors. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection. Advise patients that Janus kinase inhibitors increase the risk of herpes zoster, and some cases can be serious [see Warnings and Precautions].

Malignancies and Lymphoproliferative Disorders: Inform patients that Janus kinase inhibitors may increase the risk for developing lymphomas and other malignancies including skin cancer. Instruct patients to inform their health care provider if they have ever had any type of cancer. Inform patients that periodic skin examinations should be performed while using OPZELURA. Advise patients that exposure to sunlight, and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions].

Major Adverse Cardiovascular Events: Advise patients that events of major adverse cardiovascular events (MACE) including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, have been reported in clinical studies with Janus kinase inhibitors used to treat inflammatory conditions. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions].

Thrombosis: Advise patients that events of DVT and PE have been reported in clinical studies with Janus kinase inhibitors used to treat inflammatory conditions. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions].

Thrombocytopenia, Anemia, and Neutropenia: Advise patients of the risk of thrombocytopenia, anemia, and neutropenia with OPZELURA. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of thrombocytopenia, anemia, or neutropenia [see Warnings and Precautions].

Administration Instructions: Advise patients or caregivers that OPZELURA is for topical use only [see Dosage and Administration].

Advise patients to limit treatment to one 60 gram tube per week or one 100 gram tube per 2 weeks [see Dosage and Administration].

Pregnancy: Inform patients to report their pregnancy to Incyte Corporation at 1-855-463-3463 [see Use in Specific Populations].

Lactation: Advise a patient not to breastfeed during treatment with OPZELURA and for about four weeks after the last dose [see Use in Specific Populations].

Manufactured for: Incyte Corporation 1801 Augustine Cut-off Wilmington, DE 19803 OPZELURA is a registered trademark of Incyte. All rights reserved.

U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 9079912; 9974790; 10639310; 10610530; 10758543; 10869870; 11219624 © 2022-2023 Incyte Corporation. All rights reserved.

Issued: July 2022 PLR-OPZ-00022-JUN23

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letter from the founder

Craig Schuette

Advancing Patient Access Together D

ear BCoD members and dermatology access staff, In this issue of Access Dermatology, we address the significant impact of artificial intelligence (AI) on our workflow. The integration of AI technology is reshaping our industry, and we are committed to exploring how these advancements, in conjunction with the expertise of biologic coordinators, can enhance our practices and improve patient outcomes.

We will also explore AI utilization at our upcoming BCoD conference, which remains the premier event for biologic coordinators.

This year’s agenda promises to be more impactful than ever, featuring parallel tracks tailored to all levels of biologic coordinators and access managers.

A highlight this year is the BCoD Masterclass Workshop, where biologic coordinators will be provided with a newly introduced BC binder. This binder contains drug-specific protocols designed to simplify authorizations and tackle denials.

We are excited to welcome specialty pharmacies and innovative companies to the conference. Their participation will offer valuable insights into maximizing the use of their services, equipping you with the tools and knowledge to effectively support your office and patients.

Additionally, we are inviting leading technology companies, including those with controversial perspectives, because we believe that open dialogue contributes to better patient care and outcomes. We value diverse viewpoints and the opportunity to discuss the latest innovations and challenges in our field.

We extend our heartfelt gratitude to the pharmaceutical companies supporting our conference, who share our mission and keep our members informed about the rapidly evolving landscape. Your support is vital, and we are honored to work alongside you.

With over 2,000 members and growing daily, our community is vibrant and expanding.

As always, our dedication to delivering the most meaningful agenda for biologic coordinators remains unwavering.

The support from our non-physician-owned conference plays a crucial role in our efforts to innovate learning methods and further the professional development of our BCs. This reflects our dedication to advancing the field and supporting you.

Lastly, I want to extend my heartfelt thanks to you as a member of BCoD. Your dedication and expertise are crucial as we work together on the front lines of access. The BCoD case studies, which highlight reduced time to fill and improved workflow and satisfaction, underscore the impact of our collective commitment. As we’ve emphasized from the beginning—and as these results confirm— Together, we advance patient access.

— CRAIG SCHUETTE Executive Director, BCoD Founder, Access Dermatology

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By He ather Sawrey CO-FOUNDER OF BCOD, GWU DEPARTMENT OF DERMATOLOGY, WASHINGTON, DC

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n the world of biologics and small molecule drugs, we know things change daily.

We roll with the punches, we adapt to the insurance song and dance, we speak to our patients and help them every step of the way. We have all this and more day-to-day responsibilities, along with prior approvals, denials, bridge programs and patient assistance programs. Being involved in every aspect of the process is what we do. It is a biologic coordinator’s job. And not too long ago, the business of AI moved into our space with not a lot of knowledge or explanation of the who, what, when, where, and why for it all.

Since I was not well-versed in AI information initially, I was a bit uneasy about the technology taking my job at any given time. A legit concern, right? To learn more, I spent some time with one of my BCOD colleagues and fellow speakers who has been doing a pilot for one of the AI companies in her office. I’m sharing our conversation with the BCOD community so that we can all be a little more educated on this seemingly imminent service.

I had a very interesting Q&A with my great friend, Dina Mastrani. She has worked in dermatology as a medical assistant and BC for five years.

This past January, she was offered a position of Prior Authorization Supervisor. Currently managing biologics for ten offices in North Jersey for 40 providers, she is one busy lady!

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HOW DID YOU GET STARTED IN AI AS A BIOLOGIC COORDINATOR? My company created a pilot program between multiple offices and pharmacies, including an AI company to submit prior authorizations on our behalf for biologic and oral systemic prescriptions.

WHAT EXACTLY IS AI IN THE DERM SPACE? Once a biologic or oral systemic is prescribed, an AI company is able to complete the prior authorization process from the beginning to the end, whether it is approved or denied.

WHICH AI PROGRAMS DO YOU CURRENTLY USE OR HAVE USED UP TO THIS POINT? Tandem is what we currently use and the only AI I have used so far.

IS IT ACCURATE, AND IF SO, HOW ACCURATE? The accuracy is there, but we are not at 100 percent yet.

Tandem will discuss the preferences and requirements for your office and create a workflow to meet the needs of the office. The workflow changes along the way to make the process accurate and efficient.

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DOES IT HELP OR HURT THE PA PROCESS? I feel that using an AI company helps the PA process. The prior authorization, appeals, patient assistance enrollment forms, patient assistance foundation forms, and forwarding of the prescription to the mandated pharmacy or to the pharmacy HUB are all completed by the AI company.

ARE THERE ANY BENEFITS TO USING AI? IF SO, WHAT ARE THEY? Yes, when using AI, you can be sure the patient will receive their medication, whether they are approved or denied from their mandated pharmacy or through the HUB. A lot of the work that goes into the prior authorization process is taken away from the office staff, especially if the AI company has access to the office's EMR.

ANY DISADVANTAGES? None yet that we have not been able to work through.

WOULD YOU RECOMMEND IT? WHY OR WHY NOT? Yes, with so many different biologic medications and different requirements needed to start the medication, things can get confusing for the clinical staff. I think having an AI company assist with the process will take a lot of the back work away from the clinical staff, and it avoids delay from the offices due to missed information.

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CAN YOU WALK US THROUGH THIS PROCESS STEP BY STEP? 1 A biologic prescription is sent to the AI company.

2 A task is sent from the office to the biologic coordinator to add the patient to the tracking sheet.

6 If approved, the AI company forwards the prescription to the mandated pharmacy through our EMR, so we can see what pharmacy the last prescription is sent to.

3 The AI company has access to our EMR, and a task is sent from the AI company confirming they have received the prescription.

7 If denied, the AI company will notify the office asking if any additional information should be included in the appeal and they will forward the prescription to the HUB.

4 If an enrollment form has not been filled out by the office, the AI company will contact the patient for a signature and send a link for a provider's signature through tasks.

8 The appeal is submitted from Tandem. If approved, the AI company forwards the prescription to the mandated pharmacy through our EMR.

5 Prior Authorization is submitted from the AI company.

WHAT DO YOU LIKE OR DISLIKE ABOUT AI? I like that they are not a pharmacy, so their main goal is not to fill the prescription but to process the prior authorization quickly and correctly.

I think follow-ups on approved prescriptions with mandated pharmacies would eliminate a lot of the issues that come after the fact.

DO YOU FEEL LIKE BC JOBS SHOULD FEEL THREATENED

BY AI? Yes, I feel if an office trusts the AI companies to process the prior authorizations on their behalf, they will not feel the need to have a BC position within their company.

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DO YOU STILL NEED HUMAN INVOLVEMENT WHEN USING AI FOR BIOLOGICS PAS, BRIDGE PROGRAMS AND OTHER TASKS? Yes, I think that biologic PAs need to be managed and maintained to be sure the process is done in a timely manner. Delays happen for a number of reasons, and there are always problems and issues that come through after prescriptions are approved.

HOW DOES THE AI COMPANY SEND ENROLLMENT FORMS TO THE HUB AND FOR BRIDGE, ETC., WITHOUT HUMAN HELP? They get the patient’s signature and send us the form for provider signature.

T IS IT TRULY ALL “ROBOTIC” OR ARE THE COMPANY’S EMPLOYEES DOING ALL OF THIS? Employees. I communicate with someone through tasks.

*

CONCLUSION

†

Being informed and educated is going to be important with the AI era upon us. We as BCs should strive to be well equipped with the questions to ask if a company is bringing this service into our clinics. Don’t be afraid to reach out to these companies and ask the hard questions. Ask how you can be an integral part of the whole AI process and how your clinic can benefit from both your position and the AI service you’ve partnered with to make the patients happy and the office even more efficient!

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With the

Commercial Bridge Program offered exclusively

through our Enhanced Services Specialty Pharmacy (SP) Network*, you can be confident that your eligible patients will get access to OPZELURA.†

To qualify, a patient must:

Getting started:

• Have commercial prescription drug insurance

1. Send your prescription to a participating pharmacy (see QR code)

• Have been prescribed OPZELURA according to the prescribing information

2. Provide the SP information required for a PA

• Have tried and failed a topical medication

3. Submit the PA to the payer per SP’s direction

• Have been denied coverage for OPZELURA by their payer through a prior authorization (PA)

4. Eligible patients can receive OPZELURA for $35 per tube after payer responds with a PA denial

*OPZELURA is widely available at pharmacies. Other offers and services may apply. † Terms and conditions apply. Terms of this program may change at any time.

ent No enrollmssary! form nece

Get patients to the other side.

Scan the QR code or visit opzeluraontrachcp.com to find a participating Specialty Pharmacy.

Please see Important Safety Information and Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

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O o p t

ENHANCED SERVICES SPECIALTY PHARMACY NETWORK

O p

L J i

I

SPECIALTY PHARMACY NAME

NPI

ADDRESS

PHONE

FAX

SHIPS TO

Blue Sky Specialty Pharmacy

1285027391

1501 Belle Isle Ave, #150 Mount Pleasant, SC 29464

843-352-7662

833-898-3992

Nationwide

Gentry Health Services

S

P a d

•

•

•

1073018438

33381 Walker Rd, Suite A Avon Lake, OH 44012

Lumicera Specialty Pharmacy

1235580697

9185 E Pima Center Pkwy, #200 Scottsdale, AZ 85258

855-847-3553

Lumicera Specialty Pharmacy

1821575200

20501 Seneca Meadows Pkwy, #120 Germantown, MD 20876

855-847-3553

855-847-3558

Nationwide, Puerto Rico Does not ship to AR

Lumicera Specialty Pharmacy

1073947636

310 Integrity Dr Madison, WI 53717

855-847-3553

855-847-3558

Nationwide, Puerto Rico Does not ship to AR

Noble Health Services - Northeast

1750626453

6040 Tarbell Rd Syracuse, NY 13206

888-843-2040

888-842-3977

Nationwide, Puerto Rico

Noble Health Services - Southeast

1417469388

2506 Lakeland Dr, #201 Jackson, MS 39232

866-420-4041

601-420-4040

Nationwide, Puerto Rico

Polaris Specialty Rx

1053486795

410 Cloverleaf Dr Baldwin Park, CA 91706

626-626-9400

800-540-3400

Nationwide

Professional Arts Specialty Pharmacy

844-443-6879

844-329-2447

OH, MI, IN, KY, PA

855-847-3558

Nationwide, Puerto Rico Does not ship to AR

S p

N C t T p

V w c i

H i p r

M

I ( f t d i

M

1194890731

128 Curran Ln Lafayette, LA 70506

888-237-4737

855-724-6797

Nationwide

Quality Drug Clinical Care

1003698820

18 Technology Dr, #104 Irvine, CA 92618

833-210-5964

833-210-5968

Nationwide, Puerto Rico Does not ship to AR

Signio Specialty Pharmacy

1730515792

100 Enterprise Dr, #501 Rockaway, NJ 07866

866-295-3015

201-313-9798

Nationwide

Please see Important Safety Information and Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

14_29_JBCOD_Artificial Intelligence_7 pages Fall_2024.indd 22

A l t p C d

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M a u i ( c

C c ( a

INDICATIONS OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include: •

Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

•

Invasive fungal infections, including cryptococcosis and pneumocystosis.

•

Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.

Thrombocytopenia, Anemia, and Neutropenia Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA. Lipid Elevations Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions In atopic dermatitis, the most common adverse reactions (≥1%) are nasopharyngitis (3%), diarrhea (1%), bronchitis (1%), ear infection (1%), eosinophil count increased (1%), urticaria (1%), folliculitis (1%), tonsillitis (1%), and rhinorrhea (1%).

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

MALIGNANCIES

Lactation

Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Please see Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte. © 2024, Incyte. 07/24

14_29_JBCOD_Artificial Intelligence_7 pages Fall_2024.indd 23

MAT-OPZ-02377

7/30/24 2:19 PM

OPZELURA® (ruxolitinib) cream, for topical use Brief Summary of FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE: OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions].

Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

• Invasive fungal infections, including cryptococcosis, and pneumocystosis.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.

The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA [see Warnings and Precautions].

MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions].

MALIGNANCIES Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions].

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke [see Warnings and Precautions].

THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately [see Warnings and Precautions].

WARNINGS AND PRECAUTIONS Serious Infections: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral Janus kinase inhibitors. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OPZELURA in patients: with chronic or recurrent infection; with a history of a serious or an opportunistic infection; who have been exposed to tuberculosis; who

14_29_JBCOD_Artificial Intelligence_7 pages Fall_2024.indd 24

of endemic tuberculosis or withand TRu (TRuE-AD1 have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or withor endemic mycoses; underlying conditions may predispose them to infection. patients for dermatitis w underlying conditions that may predispose them tothat infection.

Closely monitor patients for Closely monitoratopic the symptoms development signs and symptoms infection during withof subj group, 62% the development of signs and of of infection during and afterof treatment with and after treatment OPZELURA. Interrupt OPZELURA a patient develops a serious infection, an opportunistic and 4% were Asian OPZELURA. Interrupt OPZELURA if a patient develops a seriousif infection, an opportunistic infection, or sepsis.until Do not OPZELURA until the infection is controlled. and at a greater in infection, or sepsis. Do not resume OPZELURA theresume infection is controlled.

OPZELURA (N=499) : No cases of active tuberculosis (TB) were reported in clinical trials with Tuberculosis: No cases of active tuberculosis (TB) were reported in clinical trials with adverse event (TEAE Cases ofinactive TBtrials wereofreported in clinical kinase OPZELURA. Cases of active TB were reported clinical oral Janus kinase trials of oral Janus (1%) vs 0for(0%), Ea inhibitors used to treat Consider inflammatory conditions.

Consider inhibitors used to treat inflammatory conditions. evaluating patients for evaluating 4patients 4 (1%) vs 0 administration of OPZELURA. DuringUrticaria OPZELURA latent and active TB infection prior to administration of OPZELURA. During OPZELURA 3 (1%) vs 0 (0%), an use, monitor patients for the development of signs and symptoms of TB. Adverse(e.g., reactions reactivation, including cases of(e.g., herpes virus reactivation Viral Reactivation: Viral reactivation, including: Viral cases of herpes virus reactivation OPZELURA herpes zoster),trials werewith reported clinicalinhibitors trials with Janus used togroup a herpes zoster), were reported in clinical Janusinkinase used to kinase inhibitors pyrexia, seasonal treat including inflammatory conditions OPZELURA. If a patient develops herpes treat inflammatory conditions OPZELURA. If aincluding patient develops herpes acneiform dermatit consider interrupting zoster, consider interruptingzoster, OPZELURA treatment until OPZELURA the episodetreatment resolves. until the episode resolves.

Nonsegmental Vitilig Hepatitis B and C: The impact used of Janus kinase inhibitors used to treat inflammatory Hepatitis B and C: The impact of Janus kinase inhibitors to treat inflammatory 449 adu conditions including on chronic viral hepatitis reactivation isTRuE-V2), unknown. conditions including OPZELURA on chronic viralOPZELURA hepatitis reactivation is unknown. vitiligotrials. were treated PatientsBwith history ofwere hepatitis B orfrom C infection Patients with a history of hepatitis or Cainfection excluded clinicalwere trials.excluded from clinical subjects were fe Hepatitis viral load (HBV-DNA titer) associated increases, with or without associatedofelevations Hepatitis B viral load (HBV-DNA titer)Bincreases, with or without elevations The in adverse alanine aminotransferase and aspartate aminotransferase, have beenAsian. reported in alanine aminotransferasein and aspartate aminotransferase, have been reported in ≥ 1% and at least 1% is not patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not OPZELURA initiation period are as follow recommended in patients with active hepatitis B or hepatitis C. any treatment emer In a large, randomized, study of an oral JAK inhibitor Mortality: In a large, randomized, postmarketing safety studypostmarketing of an oral JAK safety inhibitor 26 (6%) vs 2 (1%), in patients rheumatoid years of ageone and older with at least Headache one in rheumatoid arthritis (RA) 50 arthritis years of (RA) age patients and older50with at least 5 (2%), 1 factor, a mortality, higher rate of all-cause mortality, including sudden cardiovascular risk factor,cardiovascular a higher rate risk of all-cause including sudden site erythema 7 (2% observed treated with the JAK inhibitor cardiovascular death, wascardiovascular observed in death, patientswas treated with in thepatients JAK inhibitor Adverse reactions t Consider theindividual benefits patient and risks for the individual patient compared with TNF blockers. Consider the benefits and risks for the the OPZELURA gro prior to initiating or continuing therapy with OPZELURA. hypertension, anxie Malignancy and Lymphoproliferative Disorders: Malignancies, including lymphomas, Malignancies, including dermatitis lymphomas,contac were observed in clinical trials of oral JAK inhibitors used to treat inflammatory inhibitorsconditions. used to treat inflammatoryinfluenza-like conditions. illnes Patients who are current or Patients past smokers who are arecurrent at additional or pastincreased smokersrisk. are at Malignancies, additional increased risk. Malignancies, DRUG including lymphomas, have including occurred lymphomas, in patients receiving have occurred JAK inhibitors in patients used receiving to treatJAK inhibitors used toINTERACTI treat Drug interaction s inflammatory conditions. In inflammatory a large, randomized, conditions. postmarketing In a large, randomized, safety study postmarketing of an oral safety study of an oral known to be a su JAK inhibitor in RA patients, JAK a higher inhibitor rate in of RA malignancies patients, a (excluding higher ratenon-melanoma of malignanciesskin (excluding non-melanoma skin may increase cancer) was observed in patients cancer) treated was observed with the JAK in patients inhibitortreated compared withtothe those JAK treated inhibitor compared to those treated ruxo decrease ruxolitini with TNF blockers. A higher with rate of TNF lymphomas blockers. Awas higher observed rate ofinlymphomas patients treated was observed with the in patients treated with the Strong Inhibitors JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancersA higher rate of lung cancers inhibitors of CYP3 was observed in current or past smokers treated with the JAK inhibitor compared to those JAK inhibitor compared to those ruxolitinib and cou treated with TNF blockers.treated In this with study,TNF current blockers. or past In this smokers study,had current an additional or past smokers had an additional increased risk of overall malignancies. increased risk Consider of overall the malignancies. benefits and risks Consider for thetheindividual benefits and risks for the individual USE IN SPECIFIC patient prior to initiating or patient continuing priortherapy to initiating with OPZELURA, or continuingparticularly therapy with in patients OPZELURA, particularlyPregnancy in patients with a known malignancy (other with than a known successfully malignancy treated (other non-melanoma than successfully skin treated cancers), non-melanoma skin cancers),Exposu Pregnancy patients who develop a malignancy when on treatment, and patients who are currentand or patients who are current orin preg outcomes past smokers. persons exposed Non-melanoma Skin Cancers: Non-melanoma Non-melanoma Skinskin Cancers: cancers Non-melanoma including basal skincellcancers and including basal cell and exposure by callin squamous cell carcinoma have squamous occurred cellincarcinoma patients treated have occurred with OPZELURA. in patientsPerform treated with OPZELURA. RiskPerform Summary periodic skin examinationsperiodic during OPZELURA skin examinations treatment during and OPZELURA following treatment treatmentasand following treatment as are not sufficient to appropriate. Exposure to sunlight appropriate. and UVExposure light should to sunlight be limited andby UVwearing light should protective be limited by wearing protective other adverse mater clothing and using broad-spectrum sunscreen. of ruxolitinib to pre Major Adverse Cardiovascular Events (MACE): In a large, randomized, postmarketing In a large, randomized, postmarketing adverse developme safety study of an oral JAK inhibitor safety in study RA patients of an oral50JAK years inhibitor of ageinand RAolder patients with50atyears least one of age and older withThe at least one background cardiovascular risk factor, acardiovascular higher rate of risk major factor, adverse a higher cardiovascular rate of major events adverse (MACE) cardiovascular events (MACE) are un populations defined as cardiovascular death, defined non-fatal as cardiovascular myocardial infarction death, non-fatal (MI), and myocardial non-fatalinfarction stroke (MI), and non-fatal stroke outc other adverse was observed with the JAK inhibitor was observed compared withtothe those JAKtreated inhibitorwith compared TNF blockers. to thosePatients treated with TNF blockers. birthPatients defects and m who are current or past smokers are at additional increased risk. Consider the benefits and Consider the benefits and Data risks for the individual patient risksprior for to theinitiating individual or patient continuing priortherapy to initiating with OPZELURA, or continuing therapy with OPZELURA, particularly in patients whoparticularly are current in patients or past who smokers are and current patients or past withsmokers other and patientsAnimal with Data: other Ruxolit of organogenesis, a cardiovascular risk factors. Patients cardiovascular shouldrisk be informed factors. Patients about the should symptoms be informed of serious about the symptoms of serious rabbits.

There were cardiovascular events and thecardiovascular steps to take ifevents they occur. and the Discontinue steps to take OPZELURA if they occur. in patients Discontinue OPZELURA in patients weight of approxim that have experienced a myocardial infarction or stroke.

60 mg/kg/day. This Thrombosis: Thromboembolic events were Thromboembolic observed in clinical events trials were with observed OPZELURA. in clinical trials with OPZELURA. systemic exposure a Thrombosis, including deepThrombosis, vein thrombosis including (DVT), deep pulmonary vein thrombosis embolism (DVT), (PE),pulmonary and embolism (PE), and exposure from ruxo arterial thrombosis have been arterial reported thrombosis in patients have receiving been reported JAK inhibitors in patientsused receiving to JAK inhibitors used to affected body surfac treat inflammatory conditions. treat Many inflammatory of theseconditions. adverse reactions Many ofwere theseserious adverseandreactions were serious and lower fetal weights some resulted in death. In some a large, resulted randomized, in death. postmarketing In a large, randomized, safety study postmarketing of an oral safety study of an oral highest and matern JAK inhibitor in RA patientsJAK 50 years inhibitor of age in RA and patients older with 50 years at least of age one and cardiovascular older with at least one cardiovascular approximately 70% risk factor, higher rates of overall risk factor, thrombosis, higher rates DVT, of andoverall PE were thrombosis, observedDVT, compared and PEtowere observed compared to study in rats, preg those treated with TNF blockers. those Avoid treatedOPZELURA with TNF in blockers. patientsAvoid who may OPZELURA be at increased in patients who may be at increased lactation at doses risk of thrombosis. If symptoms risk of of thrombosis. thrombosisIf occur, symptoms discontinue of thrombosis OPZELURA occur, anddiscontinue OPZELURA and embryofetal surviva evaluate and treat patients appropriately. function at the highe Thrombocytopenia, Anemia, and Neutropenia: Thrombocytopenia, anemia, Thrombocytopenia, and anemia, and Lactation neutropenia were reported neutropenia in the clinicalwere trialsreported with OPZELURA. in the clinical Consider trials the withbenefits OPZELURA. Consider the benefits Risk prior Summary and risks for individual patients and risks whofor have individual a known patients historywho of these have events a known prior history to of these events to the breastfed initiating therapy with OPZELURA. initiatingPerform therapy CBC with monitoring OPZELURA.asPerform clinically CBC indicated. monitoring If as clinically on indicated.

If ch of lactating signs and/or symptoms of signs clinically and/orsignificant symptomsthrombocytopenia, of clinically significant anemia,thrombocytopenia, and anemia, andrats. W present in human m neutropenia occur, patients should discontinue OPZELURA. serious infections, Lipid Elevations: Treatment with oral ruxolitinib Treatment has been with associated oral ruxolitinib with increases has been associated with increasesduring t breastfeed in lipid parameters including in lipidtotal parameters cholesterol, including low-density total cholesterol, lipoprotein (LDL) low-density lipoprotein (LDL) last dose (approxim cholesterol, and triglycerides.

Data: Lactating ra ADVERSE REACTIONS (30 mg/kg) on pos Clinical Trials Experience: Because clinical trials are conducted Because clinical under widely trials are varying conducted under widely for upvarying to 24 hours. adverse in the clinical trials of a drug cannot directly plasm conditions, adverse reaction conditions, rates observed in thereaction clinicalrates trials observed of a drug cannot be directly thebematernal compared in the clinical trials not of another drugrates and may not reflect the compared to rates in the clinical trialstoofrates another drug and may reflect the severalrates of its meta observed in practice. Atopic Dermatitis: In two double-blind, Atopic Dermatitis: vehicle-controlled In two double-blind, clinical trials vehicle-controlled clinical trials

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c mycoses; or withand TRuE-AD2), 499 (TRuE-AD1 adult and pediatric subjects years age andsubjects older with (TRuE-AD1 and TRuE-AD2), 49912 adult andofpediatric 12 years of age and older with monitoratopic patients for dermatitis were treated withdermatitis OPZELURAwere twicetreated daily for weeks. In the OPZELURA atopic with8 OPZELURA twice daily for 8 weeks. In the OPZELURA ter treatment withof subjects weregroup, group, 62% females, of subjects were White, 23%ofwere Black,were White, 23% were Black, 62%and of 71% subjects were females, and 71% subjects on, an opportunistic and 4% were Asian. The adverse reactions reported ≥ 1% ofreactions OPZELURA treatedbysubjects and 4% were Asian.

Thebyadverse reported ≥ 1% of OPZELURA treated subjects ontrolled. and at a greater incidence and than atin athe vehicle arm through week are asarm follows for week 8 are as follows for greater incidence than in the 8vehicle through OPZELURA (N=499) vs VehicleOPZELURA (N=250), (N=499) respectively: Subjects with any treatment emergent vs Vehicle (N=250), respectively: Subjects with any treatment emergent clinical trials with adverse event (TEAE) 132 (27%) vs 83event (33%), Nasopharyngitis vs 2Nasopharyngitis (1%), Bronchitis13 (3%) vs 2 (1%), Bronchitis adverse (TEAE) 132 (27%) vs1383(3%) (33%), oral Janus kinase (1%) vs 0for(0%), Ear infection44(1%) (1%)vsvs00(0%), (0%),Ear Eosinophil 4 (1%) vs 0 (0%), infectioncount 4 (1%)increased vs 0 (0%), Eosinophil count increased 4 (1%) vs 0 (0%), ating 4patients 4 (1%) vs 0 (0%), Diarrhea 3 (1%) vs vs 1 (<1%), (1%)vs vs10(<1%), (0%), Tonsillitis Urticaria 4 (1%) 0 (0%),Folliculitis Diarrhea 33(1%) Folliculitis 3 (1%) vs 0 (0%), Tonsillitis DuringUrticaria OPZELURA 3 (1%) vs 0 (0%), and Rhinorrhea 3 (1%) vs 1 (<1%).

3 (1%) vs 0 (0%), and Rhinorrhea 3 (1%) vs 1 (<1%).

Adverse(e.g., reactions that occurred in TRuE-AD1 < 1% of subjects in the in < 1% of subjects in the Adverse reactions and that TRuE-AD2 occurred ininTRuE-AD1 and TRuE-AD2 s reactivation OPZELURA the vehicle group were: allergic OPZELURA group and noneneutropenia, in the vehicle groupconjunctivitis, were: neutropenia, allergic conjunctivitis, inhibitors used togroup and none in pyrexia, seasonal allergy, herpes otitisallergy, externa, Staphylococcal infection, pyrexia,zoster, seasonal herpes zoster, otitis externa,and Staphylococcal infection, and develops herpes acneiform dermatitis. acneiform dermatitis. e resolves.

Nonsegmental Vitiligo Nonsegmental Vitiligo: In two double-blind, vehicle-controlled clinical trials (TRuE-V1 and reat inflammatory 449 adult and pediatric TRuE-V2), subjects 449 adult 12 years and ofpediatric age andsubjects older with 12 nonsegmental years of age and older with nonsegmental ation isTRuE-V2), unknown. vitiligotrials. were treated with OPZELURA vitiligo were twicetreated daily for with 24 OPZELURA weeks. In the twice OPZELURA daily for group, 24 weeks.

55%In the OPZELURA group, 55% om clinical subjects were females, and of 81% subjects of subjects were females, were White, and 81% 5% were of subjects Black,were and 4% White, were 5% were Black, and 4% were ociatedofelevations The in adverse reactionsAsian. reported Thebyadverse OPZELURA reactions reported by OPZELURA treated subjects with an incidence of e beenAsian. reported ≥ 1% and at least 1% greater≥incidence 1% and atthan least in 1% the greater vehicle arm incidence in thethan 24-week in thedouble-blind vehicle arm in the 24-week double-blind RA initiation is not period are as follows for OPZELURA period are (N=449) as follows vs Vehicle for OPZELURA (N=224), (N=449) respectively: vs Vehicle Subjects (N=224), with respectively: Subjects with any treatment emergent adverse any treatment event (TEAE) emergent 214 (48%) adverse vs 79event (35%), (TEAE) Application 214 (48%) site vs acne 79 (35%), Application site acne n oral JAK inhibitor 26 (6%) vs 2 (1%), Application 26site (6%)pruritus vs 2 (1%), 23 (5%) Application vs 6 (3%), siteNasopharyngitis pruritus 23 (5%)19vs(4%) 6 (3%), vs Nasopharyngitis 19 (4%) vs with at least Headache one 5 (2%), 17 (4%) vs56(2%), (3%),Headache Urinary tract 17 (4%) infection vs 67(3%), (2%)Urinary vs 1 (<1%), tract infection Application 7 (2%) vs 1 (<1%), Application including sudden 7 (2%) vs 1 (<1%), site erythema site erythema and Pyrexia 7 (2%) 6 (1%) vs vs 1 (<1%), 0 (0%) and Pyrexia 6 (1%) vs 0 (0%). the JAK inhibitor Adverse reactions that occurred Adverse in TRuE-V1 reactions andthat TRuE-V2 occurred in ≥in0.5% TRuE-V1 to < and 1% of TRuE-V2 subjectsinin≥ 0.5% to < 1% of subjects in e individual patient the OPZELURA group and none the OPZELURA in the vehicle group group and were: none in application the vehicle sitegroup dermatitis, were: application site dermatitis, hypertension, anxiety, application hypertension, site discoloration, anxiety, application applicationsite sitediscoloration, folliculitis, contusion, application site folliculitis, contusion, luding dermatitis lymphomas,contact, diarrhea, dermatitis ear infection, contact, gastritis, diarrhea, gastroenteritis, ear infection, hordeolum, gastritis, gastroenteritis, hordeolum, mmatoryinfluenza-like conditions. illness, insomnia, influenza-like nasal congestion, illness, insomnia, and vomiting. nasal congestion, and vomiting. risk. Malignancies, DRUGtoINTERACTIONS DRUG INTERACTIONS bitors used treat Drug interaction studies with Drug interaction studies with OPZELURA have not been conducted. Ruxolitinib is ty study of an oral known to be a substrate for known cytochrome to be a P450 substrate 3A4 for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 on-melanoma skin may increase may increase concentrations ruxolitinibwhereas systemicinducers concentrations of whereas inducers of CYP3A4 may red to those treated ruxolitinib systemic decrease ruxolitinib systemic decrease concentrations. ruxolitinib systemic concentrations. nts treated with the Strong Inhibitors of CYP3A4: Strong Avoid Inhibitors concomitant of CYP3A4: use ofAvoid OPZELURA concomitant with strong use of OPZELURA with strong ate of lung cancers inhibitors of CYP3A4 as there inhibitors is a potential of CYP3A4 to as increase there is thea systemic potential exposure to increase of the systemic exposure of compared to those ruxolitinib and could increase ruxolitinib the riskand of OPZELURA could increase adverse the risk reactions. of OPZELURA adverse reactions. had an additional s for the individual USE IN SPECIFIC POPULATIONS USE IN SPECIFIC POPULATIONS icularlyPregnancy in patients Pregnancy oma skin cancers),Exposure Registry Pregnancy Pregnancy Exposure Registry: There is a pregnancy registry that monitors pregnancy who are current orin pregnant persons outcomes outcomes exposed in pregnant to OPZELURA persons during exposed pregnancy. to OPZELURA Pregnant during pregnancy. Pregnant persons exposed to OPZELURA persons andexposed healthcare to OPZELURA providers should and healthcare report OPZELURA providers should report OPZELURA ing basal cell and exposure by calling 1-855-463-3463. exposure by calling 1-855-463-3463.

PZELURA. RiskPerform Summary Risk Summary: Available data from pregnancies reported in clinical trials with OPZELURA wing treatment as are not sufficient to evaluate are a drug-associated not sufficient torisk evaluate for major a drug-associated birth defects, miscarriage, risk for majororbirth defects, miscarriage, or wearing protective other adverse maternal or fetal other outcomes. adverseInmaternal animal reproduction or fetal outcomes. studies, In oral animal administration reproduction studies, oral administration of ruxolitinib to pregnant ratsof and ruxolitinib rabbitstoduring pregnant the period rats and of rabbits organogenesis during the resulted periodinof organogenesis resulted in zed, postmarketing adverse developmental outcomes adverse at doses developmental associated outcomes with maternal at doses toxicity. associated with maternal toxicity. der withThe at least one background risks of The majorbackground birth defects risksand of miscarriage major birth for defects the indicated and miscarriage for the indicated ular events (MACE) are unknown. populations populations All pregnancies are unknown. carry someAllrisk pregnancies of birth defects, carry some loss, risk or of birth defects, loss, or nd non-fatal stroke outcomes. The other adverse other background adverse outcomes. risk in the The U.S.background general population risk in the of major U.S. general population of major F blockers. birthPatients defects and miscarriage birth is defects 2-4% and and15-20%, miscarriage respectively. is 2-4% and 15-20%, respectively. der the benefits and Data Data y with OPZELURA, Animal Data: Ruxolitinib orally to pregnant was administered rats or rabbits orally during to pregnant the period rats or rabbits during the period atientsAnimal with Data: other Ruxolitinib was administered of organogenesis, at doses ofof15,organogenesis, 30 at doses of 15, 30, or 60 mg/kg/day in rats and 10, 30, or 60 mg/kg/day in mptoms of serious rabbits.

There were no treatment-related rabbits. Theremalformations were no treatment-related at any dose. malformations A decrease in fetal at any dose. A decrease in fetal ZELURA in patients weight of approximately 9% weight was noted of approximately in rats at the 9% highest was and noted maternally in rats attoxic the highest dose of and maternally toxic dose of 60 mg/kg/day. This dose resulted 60 mg/kg/day. in systemic This exposure dose resulted approximately in systemic 22 times exposure the clinical approximately 22 times the clinical s with OPZELURA. systemic exposure at the maximum systemic recommended exposure at the human maximum dose (MRHD; recommended the clinical human systemic dose (MRHD; the clinical systemic mbolism (PE), and exposure from ruxolitinib cream, exposure 1.5%from applied ruxolitinib twice daily cream,to 1.5% 25-40% applied atopic twice dermatitisdaily to 25-40% atopic dermatitisinhibitors used to affected body surface area is affected used body surface area is used for calculation of multiples of human exposure). In rabbits, were serious and lower fetal weights of approximately lower fetal 8%weights and increased of approximately late resorptions 8% andwere increased noted at latetheresorptions were noted at the ty study of an oral highest and maternally toxic dose highest of and maternally toxic dose of 60 mg/kg/day. This dose resulted in systemic exposure one cardiovascular approximately 70% the MRHDapproximately clinical systemic 70% exposure. the MRHD In aclinical pre-and systemic post-natal exposure. development In a pre-and post-natal development erved compared to study in rats, pregnant animals study were in rats, dosed pregnant with ruxolitinib animals were from dosed implantation with ruxolitinib through from implantation through ay be at increased lactation at doses up to 30 lactation mg/kg/day. at doses There up were to 30 no drug-related mg/kg/day. There adverse were effects no drug-related on adverse effects on ue OPZELURA and embryofetal survival, postnatal embryofetal growth, development survival, postnatal parameters growth, or offspring development reproductive parameters or offspring reproductive function at the highest dose evaluated function at(3.1 thetimes highest thedose MRHD evaluated clinical systemic (3.1 timesexposure). the MRHD clinical systemic exposure). enia, anemia, and Lactation Lactation nsider the benefits Risk prior Summary Risk Summary: There are no data on the presence of ruxolitinib in human milk, the effects se events to the breastfed effects the breastfed on milk production. child, or theRuxolitinib effects onwas milkpresent production. in theRuxolitinib milk was present in the milk nically on indicated.

If child, or theon of lactating of lactating is presentrats. in animal When amilk, drugit isis present likely that in animal the drugmilk, will itbeis likely that the drug will be nia, anemia, andrats. When a drug present in human milk. Because present of the in serious human milk. adverse Because findings of the in adults, seriousincluding adverserisks findings of in adults, including risks of serious infections, thrombocytopenia, serious infections, anemia, thrombocytopenia, and neutropenia, advise anemia,women and neutropenia, not to advise women not to ted with increases breastfeed during treatmentbreastfeed with OPZELURA during treatment with OPZELURA and for approximately four weeks after the lipoprotein (LDL) last dose (approximately last dose (approximately 5-6 elimination half-lives).

Data: Lactating rats wereData: administered Lactatinga rats single were dose administered of [14C]-labeled a single ruxolitinib dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day (3010,mg/kg) after which on postnatal plasmaDay and10, milkafter samples whichwere plasma collected and milk samples were collected nder widely for upvarying to 24 hours. The AUCforforuptotal to 24 radioactivity hours. TheinAUC milkforwas total approximately radioactivity 13 in milk timeswas approximately 13 times g cannot be directly the maternal plasma AUC. Additional the maternal analysis plasmashowed AUC. Additional the presence analysis of ruxolitinib showed and the presence of ruxolitinib and ot reflect the rates several of its metabolites inseveral milk, allofatitslevels metabolites higher than in milk, those all in at maternal levels higher plasma. than those in maternal plasma. ntrolled clinical trials

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Pediatric Use: Atopic Dermatitis: The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from TRuE-AD1 and TRuE-AD2, which included 92 pediatric subjects aged 12 to 17 years with mild-to-moderate atopic dermatitis. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established.

Nonsegmental Vitiligo: The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from TRuE-V1 and TRuE-V2, which included 55 pediatric subjects aged 12 to 17 years with nonsegmental vitiligo. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established.

Juvenile Animal Toxicity Data: Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at systemic exposures that are at least 40% the MRHD clinical systemic exposure.

Geriatric Use: Of the 1249 total subjects with atopic dermatitis in clinical trials with OPZELURA, 115 (9%) were 65 years of age and older. No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

Of the 831 total subjects enrolled with nonsegmental vitiligo in clinical trials with OPZELURA, 65 (8%) were 65 years of age and older. Clinical trials of OPZELURA in subjects with nonsegmental vitiligo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

PATIENT COUNSELING INFORMATION Advise the patient or caregivers to read the FDA-approved patient labeling (Medication Guide).

Infections: Inform patients that they may be at increased risk for developing infections, including serious infections, when taking Janus kinase inhibitors. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection. Advise patients that Janus kinase inhibitors increase the risk of herpes zoster, and some cases can be serious [see Warnings and Precautions].

Malignancies and Lymphoproliferative Disorders: Inform patients that Janus kinase inhibitors may increase the risk for developing lymphomas and other malignancies including skin cancer. Instruct patients to inform their health care provider if they have ever had any type of cancer. Inform patients that periodic skin examinations should be performed while using OPZELURA. Advise patients that exposure to sunlight, and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions].

Major Adverse Cardiovascular Events: Advise patients that events of major adverse cardiovascular events (MACE) including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, have been reported in clinical studies with Janus kinase inhibitors used to treat inflammatory conditions. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions].

Thrombosis: Advise patients that events of DVT and PE have been reported in clinical studies with Janus kinase inhibitors used to treat inflammatory conditions. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions].

Thrombocytopenia, Anemia, and Neutropenia: Advise patients of the risk of thrombocytopenia, anemia, and neutropenia with OPZELURA. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of thrombocytopenia, anemia, or neutropenia [see Warnings and Precautions].

Administration Instructions: Advise patients or caregivers that OPZELURA is for topical use only [see Dosage and Administration].

Advise patients to limit treatment to one 60 gram tube per week or one 100 gram tube per 2 weeks [see Dosage and Administration].

Pregnancy: Inform patients to report their pregnancy to Incyte Corporation at 1-855-463-3463 [see Use in Specific Populations].

Lactation: Advise a patient not to breastfeed during treatment with OPZELURA and for about four weeks after the last dose [see Use in Specific Populations].

Manufactured for: Incyte Corporation 1801 Augustine Cut-off Wilmington, DE 19803 OPZELURA is a registered trademark of Incyte. All rights reserved.

U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 9079912; 9974790; 10639310; 10610530; 10758543; 10869870; 11219624 © 2022-2023 Incyte Corporation. All rights reserved.

Issued: July 2022 PLR-OPZ-00022-JUN23

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CONFERENCE REGISTRATION

NOW OPEN REGISTER TODAY FOR THE CONFERENCE FOR BIOLOGIC COORDINATORS

OCTOBER 27-29, ORLANDO, FL | JW MARRIOTT BONNET CREEK Join us at the BCoD 2024 Conference for an unmatched opportunity to grow your career in dermatology patient access. This event is perfect for biologic coordinators, medical assistants, and healthcare workers looking to enhance patient access in dermatology. With innovative workshops, learning opportunities, and the chance to network with experts, this conference is your key to unlocking new professional heights. Take advantage of this chance to connect with peers and boost your skills.

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NEED ANOTHER ANOTHER REASON REASON TO ATTEND THE THE BCOD BCOD NATIONAL CONFERENCE CONFERENCE THIS YEAR? BCOD BCOD MASTERCLASS: MASTERCLASS: New Newthis thisyear, year,we weare are introducing introducing a special workshop, workshop, the theBCoD BCoDMasterclass, Masterclass, focused focusedon onreducing reducing script script fulfillment fulfillment delays, promoting promoting team teamcommunication, communication, and andenhancing enhancingpatient patient satisfaction. satisfaction. Attendees Attendees will will receive receiveaaBiologic BiologicBinder, Binder, aavaluable valuableresource resourcefor for office office staff staff to facilitate drug drug approvals approvalsand andenhance enhance documentation documentationwithin within EHR EHR systems. systems.

ENHANCING ENHANCING OFFICE WORKFLOWS: WORKFLOWS:

The The training training session session aims to establish establish and and enhance enhance office office workflows workflows to ensure efficient efficient drug drug fulfillment. fulfillment.This This includes includes optimizing optimizing processes processes and and protocols protocolsfor forfaster faster medication medication approvals. approvals.

TEAM TEAM COHESION: COHESION:

BCoD BCoD will will guide guide practices in fostering fostering cohesive cohesiveteamwork teamwork within within the the office. office. This teamwork teamwork is is crucial crucial for forstreamlining streamlining operations operations and and reducing delays delays in in patient patient care. care.

UTILIZATION UTILIZATION OF TECHNOLOGY TECHNOLOGY PLATFORMS: PLATFORMS:

Drawing Drawing on on experience experience with EMA, EMA, Epic, Epic, and and other othertech tech platforms, platforms, the the session session will provide provide insights insights into intoleveraging leveraging these these tools tools effectively. effectively. This can can significantly significantlycontribute contributeto to reducing reducing administrative administrative burdens burdens and and improving improvingefficiency. efficiency.

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COMPREHENSIVE COMPREHENSIVE TRAINING TRAINING MATERIALS: MATERIALS:

Participants Participants will will receive comprehensive comprehensive materials materialsand and guides guides covering covering brand-specific brand-specific approval approval documents, documents, EMR EMR setup setup instructions, instructions, process process and and protocol protocolbest best practices, practices, and and biosimilar drug drug lists. lists. These These resources resourcesare are designed designed to to equip equip staff with the the necessary necessaryknowledge knowledgeto to expedite expedite medication medication processes. processes.

BIOLOGIC BIOLOGIC BINDER: BINDER:

Attendees Attendees will will receive receive a robust robust biologic biologic binder, binder,which which includes includes never-before-seen never-before-seen content. content. This This binder binderaims aims to to serve serve as as a a practical practical tool for for offices offices and and new newstaff, staff, providing providing readily readily accessible information information to tofurther further optimize optimize medication medication management. management.

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Join Join BCoD BCoD and and attend our 2024 2024 National NationalConference Conference for for this this masterclass masterclass and many many additional additional empowering empowering workshops workshops and and presentations. presentations.

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Register Register at at www.bcofdermatology.com www.bcofdermatology.com

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MEDICAL SCIENCE LIAISON EXPERTS PROVIDE RESOURCES AND SUPPORT

RFRETRRYRTYTRYRTY

I

t goes without saying that we all—especially you as a biologic coordinator—can appreciate the complexities of the current healthcare environment. When it comes to your role as a biologic coordinator (BC) and navigating the various processes required for accessing and understanding the medication landscape, there are several different roles through which pharmaceutical companies strive to provide resources and support. No doubt you are familiar with many of these valuable resources (e.g. sales, access/reimbursement roles), but there is also another role in the industry that many BCs around the country are utilizing when they experience situations that require a different level of clinical support. Are you still sleeping on your Medical Science Liaisons (MSLs)?

ACCESS DERMATOLOGY / ISSUE 10 / 2024

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By Zac Post, Ph armD, BCPS MEDICAL SCIENCE LIAISON, DIRECTOR – ALLERGY/DERMATOLOGY NOVARTIS PHARMACEUTICALS CORPORATION

bcofdermatology.com

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WHO ARE MSLS? MSLs are medical and scientific experts responsible for building collaborative relationships with healthcare professionals (HCPs) in specific roles within pharmaceutical, biotechnology, medical device, contract research organizations (CROs), and other healthcare industries and settings. The term “MSL” may be a new one for you, but it is not a new role within the industry.

MSLs were first established in 1967 by Upjohn Pharmaceuticals as a response to the need for scientifically trained field staff who would better be able to build a rapport with Key Opinion Leaders (KOLs) in various therapeutic areas of research. Although originally called “Medical Science Liaisons” by Upjohn, over the years and today, companies have used different names for the role, including but not limited to: Medical Liaisons, Medical Managers, Regional Scientific Managers, Clinical Liaisons, Medical Advisors, and Scientific Affairs Managers.

They have advanced scientific training and credentials generally consisting of a doctorate degree (such as PharmD, PhD, MD, DNP) or an advanced degree with expertise within a particular specialty (such as NP or PA). MSLs typically focus on specific therapeutic areas (e.g., Dermatology, Cardiology, Rheumatology, Hematol and disease states (e.g., Atopic Dermatitis, Asthma, Rheumatoid Arthritis, Diabetes).

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WHAT DO MSLS DO? MSLs serve as liaisons to the medical and scientific community and are responsible for engaging HCPs in scientific discussions in a therapeutic specialty (or specialties) and within a geographical area of coverage (i.e., an MSL may cover part of a state, multiple states, or up to >50% of the U.S.; depends on many factors). In this case with dermatology, HCPs are not limited to MDs, DOs, PAs, NPs, but can also include BCs; essentially, any member of the healthcare team that could value from the scientific exchange of information accessible by MSLs. Their foundational scientific background better allows MSLs to flexibly engage in deeper discussions with various levels of HCPs, which may include: providing

education around disease states and products (e.g., therapeutic targets and drug mechanism of action [MOA]), emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, capturing adverse events, and capturing medical insights from HCPs to help shape future research and developments.

HOW DO MSLS DO IT? It is important to note that MSLs facilitate the exchange of factual and unbiased scientific information between the medical community and the pharmaceutical industry in an entirely non-promotional manner.

And as stated in their job title, MSLs truly do “liaise.” Just as a sales representative for a particular product(s) is your contact/ gateway to the commercial side of the company they support, an MSL is your contact/gateway to the medical side of that same organization. So aside from being entirely non-promotional, how else are MSLs different from other supportive roles you may encounter as a BC (e.g., sales representatives, access/reimbursement managers)?

WHAT MAKES US DIFFERENT This figure illustrates (at a high level) an example of where various functions sit within a given pharmaceutical company on both the Medical (left) and Sales/

Figure adapted from: MSLs. Accessed October 26, 2023; themsls.org/what-is-an-msl/

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“MSLs have access to the most timely and relevant data analyses available for the products and pipeline they support, whether it is available in the public domain (published) or even unpublished as well.”

Commercial (right) perspectives. At the very center of these roles is the HCP (and ultimately the patients they serve), and all the surrounding functions each have a unique role and value they can provide.

As demonstrated at the bottom left of the figure, the MSL is the primary field extension role for Medical Affairs and the Sales Representative (bottom right) is that field extension for the Commercial side of the organization, where they certainly are the best role to support in terms of gaining access via samples, insurance questions, and patient assistance programs.

Perhaps the biggest differentiator for MSLs is the fact that the role is entirely non-promotional in nature. Within their role, MSLs have access to the most timely and relevant data analyses available for the products and pipeline they support, whether it is available in the public domain (published) or even unpublished as well.

This also includes data that is considered both on- (or consistent with) label and off-label, with well-defined guardrails around what information can be compliantly communicated proactively or reactively during scientific discussions. That access to information is certainly a difference from their sales counterparts that are more limited to the information they are able to share and discuss from a compliance perspective (must all be considered "consistent with the approved label for a product").

The MSLs also have a different foundational background, so when it comes to educational content around product or disease state like a drug MOA, for example, MSLs will be able to provide a deeper level of understanding but also tailor that response to what the HCP is looking for (whether a deep 30-minute discussion or a quick “down and dirty” 30-second answer).

Aside from being a comprehensive medical information resource for the medical community within their area of coverage, MSLs wear a lot of other hats such as training speakers, supporting advisory boards, and also activities related to initiating and supporting clinical trial sites for potential future therapies/indications in the pipeline.

TAKEAWAY: MSLS AND BCS Your MSL can be a valuable resource for clinical information and data related to the disease states and products that they support. This may be particularly helpful for you in your role as a BC when looking for this type of information to support justification and access for a product when written for a particular disease state or dose. This has personally been the scenario where I have not only most frequently interacted with BCs (by BC contacting MSL), but also where the BCs have found most value from the MSL as a timely and comprehensive medical information resource.

PRO TIP!

If you feel you may find value in having access to this type of resource in your role as a BC, consider asking your local sales representative for a particular company to put you in touch with their MSL. Having that MSL’s contact information can save you some time in the long run if you ever do need to quickly access them.

REFERENCES: 1. MSLs. Accessed October 26, 2023; themsls.org/what-is-an-msl/

*DISCLAIMER The views and opinions expressed in this document are those of the author and do not necessarily reflect the official policy or position of Novartis or any of its officers. bcofdermatology.com

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Once a prescribing decision has been made to prescribe TREMFYA® (guselkumab), enroll patients in

A dedicated support program for TREMFYA® patients

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At TR qu can

TREMFYA withMe provides a range of dedicated support to help make it easier for patients as they begin, and continue, their TREMFYA® treatment journey.

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The TREMFYA withMe Guide At the core of the program is a TREMFYA withMe Guide, a dedicated and qualified healthcare professional* who can work one-on-one with patients to:

Answer questions about prescription fulfillment and cost support Patients will receive education on specialty medication fulfillment and options that could make their treatment more affordable.

Connect patients to injection support You are the best person to review the injection process with your patients and help them understand what to expect. The TREMFYA withMe Guide is also available, after you have talked with your patients, if they have questions about injections.

Help with treatment expectations Patients will get information on what to expect with their TREMFYA® treatment.

Provide regular updates and reminders at the patient’s request Patients may receive support to help them stay on track with their treatment, plus updates on their TREMFYA® treatment journey.

Our goal is to provide a live person who can compassionately deliver the precise information that patients may want to help them with their treatment.

The TREMFYA withMe Guide can also help patients access other channels of support. *Guides do not provide medical advice.

© Janssen Biotech, Inc. 2022

09/22

cp-333177v1

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ACCESS MANAGEMENT TIPS TO STAY ORGANIZED AND OFFER HIGH-QUALITY CARE

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By Alis a Redmon BIOLOGIC AND MEDICATION ACCESS COORDINATOR

“For every minute spent organizing, an hour is earned.”

–BENJAMIN FRANKLIN

Y

ou’ve done it. You have fought the fight with the insurance company and the pharmacy. You have worked with your Field Reimbursement Managers (FRMs)

and Access Specialist to get the patient started on treatment. Your patient is now on the biologic that your prescriber requested. You know the feeling. Now, what? How do you make sure all your hard work doesn’t go to waste? Any hiccup could jeopardize the patient’s treatment and your time.

More initiations = more people we are helping = more information to keep track of Depending on your practice setting, the number of biologic initiations can range

daily. In addition to new patients, are those already established on therapy who have an expiration date. Once you get that approval, the clock is ticking until we must get the patient back in the office for re-evaluation. As you know, the initial approval window seems to be getting shorter and shorter. There are still some plans that will never give a year-long approval. So, some patients will be coming into the office for follow-ups more than others. Once we have an end date for coverage, the appointment date is vital to avoid the possibility of a lapse in coverage and therapy. bcofdermatology.com

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WHAT INFORMATION IS MOST IMPORTANT TO KNOW ABOUT EACH PATIENT?

THE BASICS Name, date of birth, contact information, medication

COVERAGE Determination status and assistance status

INSURANCE Medical, Pharmacy Benefit Manager (PBM) and Specialty Pharmacy (SP) This information can change randomly or yearly.

It is important your patient is aware that you need to know if they are changing insurance. Most patients don’t think to let their health providers know this information until they see them again.

Learning what insurance plans, PBMs, and SPs are contracted together will help speed up your process.

APPOINTMENTS The patient must stay current with follow-ups to ensure up-to-date documentation can be provided when renewal is due.

LABS/TB TEST DUE DATE Every Prior Authorization (PA) request is going to ask about a negative TB (if applicable). This is one box we just want to be able to check YES and move on from there.

ADDITIONAL NOTES This can be reserved for short notes that the biologic coordinator (BC) wants to remember about the patient’s case.

Some examples include: If correspondence was received from the SP that they were unable to contact the patient for delivery; an appeal is being planned at a future date; or if the patient can’t make their appointment before the approval end date.

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“All worries are less with cheese.”

– AMIT KALANTRI

SPECIALTY PHARMACIES: TO UTILIZE OR NOT Each bit of information is a slice of Swiss cheese in the patient’s care management.

The Swiss Cheese Model is something I learned in school, and it has always stuck with me. This model is used in risk analysis and management as a mitigation tool, originally introduced by James T. Reason, once a professor of psychology at the University of Manchester.

He proposes this theory in his book, Human Error. According to this model, accidents are caused by a breakdown of safety barriers across four levels within a system. THE FOURTH LEVEL: Organizational Influences.

This is my translation of each, in regard to the BCʼs role:

ORGANIZATIONAL CULTURE The shared values, beliefs, and priorities among you and your prescribers. The willingness to openly communicate and learn from each other to achieve the same goal: acquisition. Creating a rapport with your patients is an essential element.

OPERATIONAL PROCESS How you and your prescribers plan to accomplish acquisition, as reflected by documentation. How you follow-up and keep track of your patients through their journey from initiation to acquisition.

RESOURCE MANAGEMENT Support provided by senior leadership to accomplish your objectives, including the resources you need to do your job efficiently and effectively.

If you don’t have the experience of navigating through the acquisition process, you may be utilizing a specialty pharmacy to help you with PAs, patient assistance forms, and appeals. From my experience, the fewer hands in the pot the better. The patient is going to call you about any questions they have regarding their biologic medication.

It is better to know what is going on with each patient, rather than having to make another phone call and wait for someone to get back to you. It may seem like more work, but it is much more efficient than using a go-between who is depending on you for information. Any FRM will tell you that their offices who do their own PAs and appeals in house have a much better acquisition rate than those who utilize specialty pharmacies.

1. Reason JT. Human Error.

Cambridge, England: Cambridge University Press. 1990

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HELPFUL TIPS 1. PATIENT EDUCATION

BIOLOGIC COORDINATORS SHOULD BE IN TUNE WITH EACH PATIENT Just as important as medication acquisition is access management and follow-up of your established biologic patients. Once patients are on treatment, we want to avoid lapses in therapy, so they stay at optimal function. An organized tracking system is vital to efficiency and quality of care, ultimately making the BC’s work easier month-by-month.

The effort put into an organized system is going to be vital to the BC’s efficiency and patient compliance. Staying up to date with patients’ status will mitigate any interruptions in treatment, keep the BC prepared, and help with time management. The goal is to safeguard that a patient’s therapy is working for them and improving their quality of life. If the BC is confident and knows what is going on with each patient, the patient is also going to be more confident in their treatment.

Biologics, and the conditions they treat, can be very overwhelming. Patient education about their condition and the process of obtaining their medication is going to be beneficial to both the patient and the BC. Have the patient check in with you every so often, especially about their refills and any other issues with the pharmacy.

2. E-SCRIBE Avoid depending on the manufacturer triaging the prescription to a specialty pharmacy. By knowing what specialty pharmacy must be used and sending in the prescription, you are able to not only track the prescription yourself, but also save a few days of processing so the patient will get their medication sooner.

3. YOUR REPS ARE YOUR FRIENDS Utilize your FRMs and Access Specialists. Let them know when you are sending over a new patient, so they can keep an eye out for it. Alert them as soon as there is an issue, so they can start helping you with

a solution. These people are your partners, and you both have the same goal.

4. STAY INFORMED Formularies and specialty pharmacies change at least yearly. Stay up to date with your most popular plans. Some PBMs have search tools to look up any medication and what the coverage criteria will be. Not all plans use CoverMyMeds, unfortunately. While it is the easiest and most efficient platform for submitting PAs, knowing which plans don’t have active or updated forms with them will save you a lot of time.

S

5. FIND YOUR COMMUNITY

B

Before I took the position as biologic coordinator for my practice, I had no idea it was an actual role. I thought we just made it up! I logged back into my LinkedIn profile, did some research, and found a whole community of BCs from all over the country. This field changes daily, and the more resources you have, the better equipped you will be to manage your patients to the best of your ability and represent your practice.

A f t

L

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Save Lives.

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TRICKS of the TRADE Helpful Tips from BCOD Members

Tara Biggers CMA, Biologic Coordinator, DERMATOLOGY GROUP OF THE CAROLINAS

Add your correct prescriptions to physician favorites in your e-scribing portal to reduce the amount of clarifications needed.

Prefilling out manufacturer forms with the providers and office information is a great way to save time.

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TRICKS OF THE TRADE

Kalie Carlton Office Manager, NORTHERN NURSE PRACTITIONERS

Ensure that your providers have the correct information needed for a patient’s note.

That will create a faster turnaround time, so the patient gets the medication they need.

Maureen Brooks

Practice Manager and Biologic Coordinator, DERMATOLOGY OF VIRGINIA

Have a discussion with the provider.

There is very specific information that the insurance companies are looking for in the patient notes to cover biologics. They are generally all the same, but some do have nuances. Your provider is the one that will make it easy on you to get it covered.

Ashley Carter Clinical Manager, Biologic Coordinator, ORCHID DERMATOLOGY

Give your patients access to you, as the biologic coordinator. The most effective way is through their patient portal, and they feel that they have a safety net if they need anything.

Create a process and a flow that works for you and keeps you organized. I use a binder to keep track of all my enrollment forms.

Make a cheat sheet with all biologics listed, ICD10 codes, lab test codes, labs required, and which biologics require signatures

Faith Daniels PA Coordinator, DERMATOLOGY ASSOCIATES OF TALLAHASSEE

Use the Optum portal. You can speak to a live person, and they assign you a field rep who is there to answer your questions.

Jo Kiehn

CMA, Biologic Coordinator, ATOMIC DERMATOLOGY

Have patients sign a consent to appeal on their behalf when theyre signing the biologic enrollment form.

Rasheedah Smith

Medical Assistant, SPARTANBURG DERMATOLOGY

Do the PA yourself if you have time; it’s faster.

I only use the specialty pharmacies for appeal help!

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TRICKS OF THE Talisa Soto TRADE Biologic Coordinator, CHICAGO SKIN CLINIC

I created a bilingual Checklist/FAQ sheet to aid patients in understanding the process while they wait for medication approval.

Rebecca Mensah

CMA, Biologic Coordinator, BRADDOCK FINNEGAN HELGET DERMATOLOGY

Jennifer Reyes

To have a routine or steps, follow with each biologic start.

That really helps to make sure you don't forget something.

Biologics Coordinator, CATSKILL DERMATOLOGY

Stay in communication with the patient until medication is in their hands. Lack of communication is how patients will fall through the cracks.

Using a patient tracker spreadsheet is a very effective and efficient way to monitor your patients prior authorization process. The sheet can be customized to fit the needs of your office and help keep records organized.

Rene Souther

Always remember no matter how complex and tough the process may be, the approval for the patient is always worth it in the end.

Keep patients updated. If the patients know what is going on, you will have fewer phone calls and happier patients.

Krystal Clayton

Biologic Coordinator, DALTON DERMATOLOGY AND DAY SPA

Review pending PAs and PAP often. This ensures the requests were received for review and that decisions are received in a timely manner.

Certified Medical Assistant, THE DERMATOLOGY SPOT

The more information regarding how the disease process is affecting the patient, along with tried and failed medications being documented in each visit note, helps tremendously with PA and appeal process.

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NOW AVAILABLE!

®

DOWN TO AGE 9

Effectively control seborrheic dermatitis and simplify treatment with a steroid-free foam.1 One foam. Once a day. Anywhere.1

SebDone.

DRAMATIC 77% IGA SUCCESS AT WEEK 81,2

Actor portrayal

Trial 203 and STRATUM studies evaluated ZORYVE (n=458) vs vehicle (n=225) once daily for 8 weeks in patients with seborrheic dermatitis. The primary endpoint was IGA Success at Week 8, defined as a score of Clear (0) or Almost Clear (1) and a ≥2-grade improvement from baseline.

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.1 IGA = Investigator Global Assessment

A 2023 Arcutis survey of 93 adults diagnosed with seborrheic dermatitis found that an average of 15 products (including over-the-counter, alternative, and prescription treatments) were reportedly used on a yearly basis. 2

INDICATION ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

See the results at zoryvehcp.com/foam Please see brief summary of full Prescribing Information for ZORYVE foam on the following page.

References: 1. ZORYVE® foam. Prescribing information. Arcutis Biotherapeutics, Inc; 2023.

2. Data on File. Arcutis Biotherapeutics, Inc. © 2024 Arcutis Biotherapeutics, Inc. All rights reserved.

US-COM-154-00125 01/24

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Brief Summary of Prescribing Information for ZORYVE® (roflumilast) foam, 0.3%, for topical use. See package insert for full Prescribing Information.

INDICATIONS AND USAGE ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

DOSAGE AND ADMINISTRATION Shake can prior to each use. Apply a thin layer of ZORYVE foam, 0.3%, once daily to affected areas on skin and/or scalp when they are not wet. Rub in completely.

Wash hands after application.

Avoid fire, flame, and smoking during and immediately following application.

ZORYVE foam, 0.3%, is for topical use only and not for ophthalmic, oral, or intravaginal use.

CONTRAINDICATIONS ZORYVE foam, 0.3%, is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

WARNINGS AND PRECAUTIONS Flammability The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 203 and STRATUM), 683 adult and pediatric subjects 9 years of age or older with seborrheic dermatitis were treated with ZORYVE foam, 0.3%, or vehicle foam once daily for 8 weeks.

The combined trial population was 79% White, 11% Black, and 5% Asian; for ethnicity, 79% identified as non-Hispanic/Latino and 21% identified as Hispanic/Latino.

Fifty percent (50%) were male and 50% were female. The median age was 41 years (range 9 to 87 years). The median body surface area (BSA) affected was 2.5%.

Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE foam, 0.3%.

Table 1: Adverse Reactions Reported in ≥1% of Subjects with Seborrheic Dermatitis Treated with ZORYVE Foam, 0.3%, for 8 Weeks in Trial 203 and Trial STRATUM Adverse Reaction

ZORYVE foam, 0.3% (N=458) n (%)

Vehicle foam (N=225) n (%)

Nasopharyngitis Nausea Headache

7 (1.5) 6 (1.3) 5 (1.1)

1 (0.4) 0 (0) 0 (0)

In a fertility and embryo-fetal development study, male rats were dosed orally with up to 1.8 mg/kg/day roflumilast for 10 weeks and females for 2 weeks prior to pairing and throughout the organogenesis period. Roflumilast induced pre- and post-implantation loss at maternal oral doses greater than or equal to 0.6 mg/kg/day (10 times the MRHD on a mg/m2 basis). Roflumilast did not cause fetal structural abnormalities at maternal oral doses up to 1.8 mg/kg/day (29 times the MRHD on a mg/m2 basis).

In an embryo-fetal development study in rabbits, pregnant does were dosed orally with 0.8 mg/kg/day roflumilast during the period of organogenesis. Roflumilast did not cause fetal structural abnormalities at the maternal oral doses of 0.8 mg/kg/day (26 times the MRHD on a mg/m2 basis).

In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day roflumilast during the period of organogenesis and lactation.

Roflumilast induced stillbirth and decreased pup viability at maternal oral doses greater than 2 mg/kg/day and 6 mg/kg/day, respectively (16 and 49 times the MRHD on a mg/m2 basis, respectively). Roflumilast induced delivery retardation in pregnant mice at maternal oral doses greater than 2 mg/kg/day (16 times the MRHD on a mg/m2 basis). Roflumilast decreased pup rearing frequencies at a maternal oral dose of 6 mg/kg/day during pregnancy and lactation (49 times the MRHD on a mg/m2 basis).

Roflumilast also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at a maternal oral dose of 12 mg/kg/day (97 times the MRHD on a mg/m2 basis).

Lactation Risk Summary There are no data on the presence of roflumilast or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.

Roflumilast and/or its metabolites are excreted into the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZORYVE foam, 0.3%, and any potential adverse effects on the breastfed infant from ZORYVE foam, 0.3%, or from the underlying maternal condition.

Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use ZORYVE foam, 0.3%, on the smallest area of skin and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, advise breastfeeding women not to apply ZORYVE foam, 0.3%, directly to the nipple or areola. If applied to the patient’s chest, avoid exposure via direct contact with the infant’s skin.

Data Animal data Roflumilast and/or its metabolite concentrations measured 8 hours after an oral dose of 1 mg/kg given to lactating rats were 0.32 and 0.02 mcg/g in the milk and pup liver, respectively.

Pediatric Use The safety and effectiveness of ZORYVE foam, 0.3%, for the treatment of seborrheic dermatitis have been established in pediatric patients 9 years of age and older. Use of ZORYVE foam, 0.3%, in this age group is supported by data from two 8-week, vehiclecontrolled trials which included 32 pediatric subjects 9 to 17 years of age, of whom 17 received ZORYVE foam, 0.3%, and from open-label trials of up to 52 weeks which included 23 pediatric subjects treated with ZORYVE foam, 0.3%. The adverse reaction profile was consistent with that observed in adults.

The safety and effectiveness of ZORYVE foam, 0.3%, in pediatric patients below the age of 9 years have not been established.

Geriatric Use Of the 683 subjects with seborrheic dermatitis exposed to ZORYVE foam, 0.3%, or vehicle for up to 8 weeks in the controlled clinical trials, 98 (14%) were 65 years of age or older, and 33 (5%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment Oral roflumilast 250 mcg once daily for 14 days was studied in subjects with hepatic impairment. The systemic exposure of roflumilast and roflumilast N-oxide were increased in subjects with moderate (Child-Pugh B) hepatic impairment. ZORYVE foam, 0.3%, is contraindicated in patients with moderate to severe liver impairment (ChildPugh B or C). No dosage adjustment is needed in patients with mild (Child-Pugh A) hepatic impairment.

PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).

Flammability Because the propellants in ZORYVE foam, 0.3%, are flammable, instruct the patient to avoid fire, flame, and smoking during and immediately following application.

Lactation Advise patients to use ZORYVE foam, 0.3%, on the smallest area of skin and for the shortest duration possible while breastfeeding. Instruct patients who are breastfeeding not to apply ZORYVE foam, 0.3%, directly to the nipple or areola to avoid direct infant exposure. Instruct patients to avoid inadvertent contact of treated areas with infant skin.

The following additional adverse reactions were reported in fewer than 1% of subjects treated with ZORYVE foam, 0.3%: diarrhea and insomnia.

In 408 subjects who continued treatment with ZORYVE foam, 0.3%, for up to 24 to 52 weeks in an open-label, long-term trial, the adverse reaction profile was consistent with that observed in vehicle-controlled trials.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are insufficient data available on the use of ZORYVE foam, 0.3%, in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 30 and 26 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 10 times the MRHD. Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 16 and 49 times the MRHD, respectively. Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 49 times the MRHD during pregnancy and lactation periods in mice.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Labor and delivery Avoid using ZORYVE foam, 0.3%, during labor and delivery. There are no human studies that have investigated effects of ZORYVE foam, 0.3%, on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice.

Data Animal data In an embryo-fetal development study, pregnant rats were dosed orally during the period of organogenesis with up to 1.8 mg/kg/day roflumilast (30 times the MRHD on a mg/m2 basis). No evidence of structural abnormalities or effects on survival rates were bcofdermatology.com observed. Roflumilast did not affect embryo-fetal development at a maternal oral dose of 0.2 mg/kg/day (3 times the MRHD on a mg/m2 basis). © 2024 Arcutis Biotherapeutics, Inc. All rights reserved.

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By Georgette Yacoub Illustrations by K as and ra Barton

healthy toes

Best Foot HOW WIDE TOE-BOX SHOES ARE TRANSFORMING

corn

H

umans first began wearing footwear as protection, but as time went on, shoes became less about or function and more about fashion.

Women of higher social status in medieval China were binding their feet to deliberately stunt their foot growth in hopes of smaller, delicate feet. The trend continued and traveled to 12th-century Europe, where a popular shoe style called the Pouline—a super narrow leather shoe with a pointed toe—was worn by higher society as a symbol of their status.

Now, we have this stylistic hangover from the middle ages where a narrow shoe with a narrow toe box has become a symbol of fashion.

Dr. Elizabeth Cody, orthopedic surgeon at Hospital of Special Surgery specializing in the foot and ankle, explains that while people think a narrower toe box is more attractive, people with wider feet find narrow shoes extremely uncomfortable. “A narrower toe box is considered more attractive in fashion shoe wear because they were basically designed for young people who have narrower feet,” she says. “As people age, their feet get wider.”

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bunion

t Forward hammer toe

claw toe

OUR FEET AND OVERALL HEALTH The narrow toe box is not a narrow problem. In fact, it’s been studied that 63 to 72% of people are wearing shoes that do not accommodate the dimensions of their feet. Hence the rise in ailments and foot deformities Dr. Cody is seeing in her patients, including bunions, hammer toes, claw toes, corns and more.

Much like a weak or deformed foundation can cause instability in a building, a weak or deformed foot can cause issues that go far beyond the foot— into the ankles, lower limbs, and higher up in the body. “If your toes are uncomfortable in a shoe, you may walk abnormally and that can lead to problems in higher up joints like the knees and even

more normally, preventing the crowding of toes that lead to other problems. Plus, they are more comfortable overall.

Some popular brands making a splash in the wide toe-box space are Flux Footwear, Vivobarefoot, and Altra Running.

your back,” says Dr. Cody.

Thankfully, there’s a small but mighty shift towards wide toe-box footwear. One that started primarily in athletic footwear and is making its transition to fashion footwear. This style of shoe allows your foot to function

“If your toes are uncomfortable in a shoe, you may walk abnormally and that can lead to problems in higher up joints like the knees and even your back."

Well-known brands like Crocs and Birkenstocks also allow the toes to splay in their natural position.

However, Cody warns that the transition to wide toe-box footwear should be gradual while your feet get time to grow strong in those newer albeit natural positions. This is particularly important for runners transitioning to wider running shoes.

As humans in the modern world, we cannot go walking around barefoot. But we can wear better shoes that support the natural function of our feet to counteract and prevent any further damage and pain to our body. The trend toward wide toe-box shoes is our step toward that.

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By Darla Hobbs MEDICAL ASSISTANT AND BIOLOGIC COORDINATOR, LOCKHART MATTER DERMATOLOGY

FROM CLINIC

BALANCING DUAL ROLES OF CLINICAL MEDICAL ASSISTANT AND BIOLOGIC COORDINATOR

A

s someone who wears the dual hats of a dermatology clinical medical assistant and

a biologic coordinator, I’ve come to understand the unique challenges that come with these roles. The complexity of managing both clinical and administrative tasks can be overwhelming, but through experience, I’ve found strategies that help maintain balance and efficiency.

The Challenge of Dual Roles The daily responsibilities of a clinical medical assistant are demanding enough, with duties ranging from patient care to assisting physicians.

Adding the role of a biologic coordinator means managing biologic prior authorizations, appeals, and staying updated with the evolving landscape of biosimilars. This dual responsibility can stretch anyone thin, making organization and prioritization crucial.

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I NATION bcofdermatology.com

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SOLUTIONS FOR ORGANIZATION AND PRIORITIZATION One of the biggest challenges is making sure to organize and prioritize tasks. I have found that maintaining a detailed calendar is essential. Here’s what works for me: 1. TASK BLOCKING

Breaking down my day into clinical and administrative blocks has helped.

Mornings are usually reserved for biologic coordination tasks.

2. PLANNER/CALENDAR

This allows me to prioritize tasks effectively and ensures that nothing falls through the cracks.

3. DAILY CHECKLISTS

Creating daily checklists for both roles provides a clear view of what needs to be accomplished. Checking off completed tasks gives a sense of accomplishment and helps maintain focus.

STREAMLINING OFFICE WORKFLOW

Finding the right office workflow has been another challenge. Communication and collaboration with my clinical and practice manager are key to streamlining processes.

1. REGULAR MEETINGS

Meetings with my clinical manager have been crucial to my success. This ensures that I have scheduled times to work biologics.

MANAGING TIME FOR PRIOR AUTHORIZATIONS AND APPEALS Biologic prior authorizations and appeals are timeconsuming but critical for patient care. Efficient time management is essential to handle these tasks effectively.

DEDICATED TIME SLOTS

Allocating specific times during the week for handling prior authorizations and appeals will ensure these task receive focused attention. Early mornings or late afternoons, when clinical activities are slower, work best for me.

2. OFFICE PROTOCOLS

Developing OP for our biologic enrollment process helps streamline everything and makes sure no one slips through the cracks.

Having a set procedure saves time and minimizes errors.

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KEEPING UP WITH THE CHANGING LANDSCAPE OF BIOLOGIC TREATMENTS 1. REGULAR TRAINING

Attending workshops, webinars, and training sessions helps keep me updated on the latest developments. Networking with colleagues and industry professionals also provides insights into best practices.

2. UTILIZING FIELD REIMBURSEMENT MANAGERS AND PHARMACEUTICAL REPS

Leveraging the expertise of field reimbursement managers and pharmaceutical reps has proven invaluable.

They provide up-to-date information, resources and support, making the process of obtaining and starting biologic medications smoother for patients.

BEING AVAILABLE FOR PATIENTS

Despite the administrative load, being available for patients and helping them navigate the biologic medication process is paramount.

1. OPEN COMMUNICATION AVENUES

Ensuring patients have multiple ways to reach me, whether through phone, email, or patient portals helps maintain accessibility. Prompt responses to their queries and concerns have built trust and eased their journey. They know I am there for them every step of the way, as we walk through this journey together.

2. PATIENT EDUCATION

Providing clear, concise information about the biologic medication process, expected timelines, and potential hurdles helps set realistic expectations.

Empowering patients with knowledge makes them active participants in their own care.

The complexity of managing both clinical and administrative tasks can be overwhelming, but through experience, I’ve found strategies that help maintain balance and efficiency.

Balancing the dual roles of a clinical medical assistant and biologic coordinator is undoubtedly challenging.

However, with strategic organization, effective time management, continuous learning, and strong patient communication, it is possible to manage both roles successfully. By staying flexible and utilizing available resources, I’ve found a way to provide compassionate care while managing administrative responsibilities efficiently.

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By Carolyn Williams BIOLOGIC COORDINATOR, PIEDMONT PLASTIC SURGERY & DERMATOLOGY

Hidradenitis Suppurativa DREAMALITTLEDREAM - STOCK.ADOBE.COM

WHAT IS IT AND HOW CAN IT BE TREATED?

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CONTRIBUTED

DREAMALITTLEDREAM - STOCK.ADOBE.COM

A

s biologic coordinators, we communicate with patients daily on both benign and complex disease states. Hidradenitis Suppurativa, commonly referred to as HS, is one of those disease states that may be unfamiliar to newly diagnosed patients.

Throughout this article, you’ll find helpful information to share with patients who are affected by HS. A diagnosis of Hidradenitis Suppurativa can feel extremely overwhelming. After a diagnosis, you may have questions surrounding how it can be treated and the impact it may have on your day-to-day activities. You may also have questions on how to inform others of your condition. Hopefully, after reading this article, you will have a better understanding of your diagnosis and will be better equipped to answer any questions and concerns.

QA EXPERT INTERVIEW

&

I had the privilege to interview Dr. Nicole Seminara, an esteemed dermatologist with extensive knowledge of HS. Dr. Seminara graduated from the University of Pennsylvania Medical School and completed her dermatology residency at Stanford University. She spent years working on cutting-edge research and has numerous articles in highly respected journals. After graduating, she joined the faculty at New York University, where she served as the director and head instructor for the dermatology curriculum. She was the youngest faculty member to ever be voted Teacher of the Year. Dr. Seminara has been featured in the Wall Street Journal, New York Times, Fox News, Smithsonian Magazine, NY Daily News, Cosmopolitan, and Vogue Business.

She is currently a partner at the largest dermatology group in the Carolinas.

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Hidradenitis Suppurativa, also known as HS, is a multisystem inflammatory condition that causes nodules and tunnels most commonly in the groin and underarms. It can also occur under the breast, on the neck and any areas of friction. These nodular tunnels can result in scars. Despite common misconceptions, HS is not related to hygiene and can affect anyone at any time; although, it disproportionately affects women of African descent. There is no current cure for Hidradenitis Suppurativa, but there has been a surge in research surrounding HS. In addition, there are numerous treatments available and soon to be approved.

WHAT COMMUNITY IS MOST COMMONLY AFFECTED BY HS? Hidradenitis Suppurativa disproportionately affects women of African descent. Both the instance and severity have been found to

be higher in this population. According to the National Library of Medicine (NIH), “The average HS prevalence rates were highest in African American women (1.3%)”, but all demographics can be affected. Ultimately, HS affects about one percent of the global population.

COMMON SIGNS OF HS In many cases, HS begins as a small abscess. Most people do not think much of it at this point, but over time as it becomes more frequent, you may start to notice more lesions or see scarring that occurs in the same area or multiple areas. Smoking and weight gain are wellknown triggers of HS. Some women may see an increase in outbreaks during their menstrual cycles. HS can affect different people differently, so it is important to pay attention to how it may be affecting you and share these findings with your provider. If a patient begins to get tunnels under the skin, they typically don’t

DREAMALITTLEDREAM - STOCK.ADOBE.COM

HS is a lifelong condition.

The biggest mistake people make is treating their HS only for flares or for short periods of time.

WHAT IS HIDRADENITIS SUPPURATIVA?

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respond well to medical treatment and the tunnels will need to be removed surgically.

DREAMALITTLEDREAM - STOCK.ADOBE.COM

WHAT ARE THE TREATMENT OPTIONS FOR HS? There are various treatments for HS. For mild cases, a provider may start you on medications like Hibiclens and Clindamycin or supplements such as zinc and vitamin D. There is evidence that laser hair removal can be effective in mild cases. For most moderate cases, antibiotics can be effective but will not work in short courses. You will need constant treatment to suppress HS, and antibiotics will not be effective if only used during flares. Doxycycline and Bactrim are common antibiotics used. Severe cases of Hidradenitis Suppurativa may require a biologic medication.

There are three classes of biologics that can be helpful: TNF agents, IL 17s, and immune modulators. Humira is an example of a biologic from the TNF agents category, and it has been shown to clear

people about 50%. However, it can lose effectiveness over time. It can be used, in some cases, in conjunction with an antibiotic. Cosentyx and Bimzelx are IL 17s. Cosentyx begins with a comparable efficacy to Humira, but over time tends to have improved efficacy. Bimzelx has not yet been approved in treatment for HS, but the preliminary data appears to be highly promising. Rinvoq, a JAK inhibitor, has also not yet been approved for treatment of HS.

ARE THESE MEDICATIONS LIFELONG MEDICATIONS? HS is a lifelong condition. The biggest mistake people make is treating their HS only for flares or for short periods of time. HS medications should be used continuously to suppress the condition. There is no current cure for hidradenitis suppurativa. For providers like Dr. Seminara, the goal is always to get their patient as close to 100% better as possible, which is why HS should be treated aggressively and continuously.

There is no current cure for Hidradenitis Suppurativa, but there has been a surge in research surrounding HS.

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UNLOCK YOUR POTENTIAL WITH BCOD

TOGETHER WE ADVANCE PATIENT ACCESS Join the Biologic Coordinators of Dermatology (BCoD) and discover a world of member benefits designed to elevate your professional journey and enhance patient care.

MEMBER BENEFITS EDUCATIONAL TRAINING

PROFESSIONAL DEVELOPMENT

RESOURCES

IMPROVE PATIENT OUTCOMES

Content designed for personal and professional growth.

Exclusive invites to educational trainings, webcasts, and meetings.

Office and patient resources for easier approvals and workflow management.

Tools and insights that enhance patient outcomes.

COMMUNITY

A platform that connects you with peers nationwide.

Embrace the vibrant community of BCoD, where each member plays a crucial role in advancing patient access.

Learn more at BCOFDERMATOLOGY.COM bcofdermatology.com

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By Liz B arron

Real Talk DEAGREEZ - STOCK.ADOBE.COM

BUSY MOM AND CONTENT CREATOR MEGAN SCHINELLA JOINS NEW PODCAST "ROOM 4 FOUR"

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Kallie Branciforte, Caitlin Houston, Megan Schinella and Charlotte Smith on the set of their new podcast, Room 4 Four.

PHOTO BY BEVY RUTLEDGE

HOW IT STARTED

Having found herself on a multi-year career hiatus after having children, blogger and influencer Megan Schinella realized when her youngest turned one, that she was ready to go back to work and carve out some time for herself. The mom of three had spent years filling her days coming up with fun and creative outings for her little ones. Schinella was often asked for suggestions and ideas about activities and events to keep their own kids entertained. “People kept telling me that I should start a blog so that I could share the fun adventures we were going on every day,” says Schinella.

burner while she raised her kids, her experience and creativity quickly proved useful in her new endeavors with creating lifestyle content. Some of the first connections that she made back in the fashion industry have now come full circle and Schinella is finding herself able to work on new partnerships with old friends once again.

Once the seed had been planted, she began to grow her Instagram presence and @campbymama officially took off. “When I first started creating content on Instagram, it was very different.

All youhad to do was post a pretty photo and people would like it," she says. "But now it’s an entirely different platform, it’s all about content creation reels and videos. You need to give people some sort of entertainment, make them laugh or provide value or an experience."

Before kids, Schinella worked in marketing in the fashion industry at Nine West Group and Camuto Group. Even though that work had been on the back

ROOM 4 FOUR

This past winter, Schinella was approached about being a part of the Room 4 Four podcast, which is owned by Seasons Media. The media production company was looking to connect four moms, each of whom would

bring something different to the table. The idea was to create a forum for the women to connect on everyday relatable topics.

Reaching out to Schinella made perfect sense.

Schinella and her co-hosts Kallie Branciforte, Caitlin Houston and Charlotte Smith cover a wide array of topics in a relatable and honest way, with just the right amount of humor thrown in. Lighter topics can range from meal planning to parenting fails, but they have also had deeper conversations about things like the feeling of isolation that can come with being a new parent and the challenges of making new mom friends. “Think of it like

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above: Joseph, Nico, Ava, Gianna and Megan Schinella

GETTING REAL

Every job comes with its difficulties and when asking Schinella about some of hers, she explained that her biggest challenge has been learning to deal with negative comments or mean messages. “I’ve developed a thicker skin and have learned to brush things off in a way that

in our home is healthy, that’s all that matters,” she adds.

I might not have been able to otherwise,” she says. Coming to terms with the fact that she’ll never be able to please everyone has helped Schinella build a sense of confidence that she didn’t always have. “It’s true that you really can’t sweat the small stuff and at the end of the day, if my kids are happy and everyone

THE BEST PART

The people, connections and community that Schinella has found through her work are what make what she does so meaningful. “I’ve met so many people through these online

platforms and events. And even though the relationships might start off as social media friendships, they very often end up becoming real life friendships,” she says. “Even if Instagram was deleted tomorrow, I’d still have those friends and I’m so grateful for that.”

UP NEXT

It feels like something that had been missing that I didn't even realize was missing until now.

— MEGAN SCHINELLA, ON HER NEW PODCAST "ROOM 4 FOUR"

Schinella plans to continue sharing interesting experiences and fashion brand styles on social media. She will continue to make us all laugh with her parenting humor reels, while also working on a few hotel partnerships documenting fun things to do, places to stay and where to eat.

When she isn’t spending time with her family, creating content or in the recording studio, you can find Schinella playing tennis, hockey for “Moms Who Puck” or taking a barre class. You can listen to Room 4 Four on your favorite podcast platform.

LOVE AND LIMONCELLO PHOTOGRAPHY

your group chat coming to life,” says Schinella. “We stay away from controversial topics and really just try to focus on positive things that help people and make them feel good.”

The podcast is unlike anything Schinella has done before and she is finding it fulfilling in ways that she didn't imagine. “It’s a very different type of creative outlet for me. It feels like something that had been missing that I didn’t even realize was missing until now,” she says. “These girls fill my cup, and I always feel good inside after recording with them and spending time together.”

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