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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.
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 thereafter according to routine patient management.
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.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
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.
Brief Summary of full Prescribing Information
Adverse Reactions in Clinical Trials of LITFULO for the Treatment of Alopecia Areata
50 mg N=130 n (%) Placebo N=213 n (%)
Headache 14 (10.8)18 (8.5)
Diarrhea 13 (10.0)8 (3.8)
Acne 8 (6.2)10 (4.7)
Rash 7 (5.4)2 (0.9)
Urticaria 6 (4.6)3 (1.4)
Folliculitis 4 (3.1)4 (1.9)
Pyrexia 4 (3.1)0
Dermatitis atopic 3 (2.3)1 (0.5)
Dizziness 3 (2.3)3 (1.4)
Blood CPK increased 2 (1.5)0
Herpes zoster 2 (1.5)0
Red blood cell count decreased 2 (1.5)0
Stomatitis 2 (1.5)0
Specific Adverse Reactions
Exposure adjusted incidence rates were adjusted by clinical trial size for all adverse reactions reported in this section.
Overall Infections
In the placebo-controlled trials, for up to 24 weeks, overall infections were reported in 66 patients (80.35 per 100 patient-years) treated with placebo and 43 patients (74.53 per 100 patient-years) treated with LITFULO 50 mg. Across clinical trials, including the long-term trial, overall infections were reported in 645 patients (50.71 per 100 patient-years) treated with LITFULO 50 mg or higher.
Serious Infections
In the placebo-controlled trials, for up to 24 weeks, 3 patients reported serious infections across all ritlecitinib doses studied. Across clinical trials, including the long-term trial, serious infections were reported in 12 patients (0.66 per 100 patient-years) treated with LITFULO 50 mg or higher. The most common serious infections were related to appendicitis, COVID-19 infection (including pneumonia), and sepsis.
Herpes Zoster
In the placebo-controlled trials, for up to 24 weeks, herpes zoster was reported in 4 patients across all ritlecitinib doses studied and 0 patients treated with placebo. Across clinical trials, including the long-term trial, herpes zoster was reported in 21 patients (1.17 per 100 patient-years) treated with LITFULO 50 mg or higher. Opportunistic infections of multi-dermatomal herpes zoster were reported in 1 patient (0.50 per 100 patient-years) treated with the ritlecitinib higher dose in the placebo-controlled trials and 2 patients (0.1 per 100 patient-years) treated with LITFULO 50 mg or higher in all clinical trials.
Malignancy
In the placebo-controlled trials, for up to 24 weeks, 1 malignancy (breast cancer) was reported in 1 patient (1.33 per 100 patient-years) treated with ritlecitinib higher dose and no malignancy was reported in patients treated with placebo. Across clinical trials, including the long-term trial, malignancies excluding NMSC were reported in 7 patients (0.37 per 100 patient-years) treated with LITFULO 50 mg or higher.
Thromboembolic Events
Across clinical trials, including the long-term trial, PE was reported in 1 patient (0.06 per 100 patient-years) treated with LITFULO. There was 1 report of retinal artery occlusion and 1 report of acute MI.
Urticaria
In the placebo-controlled trials, for up to 24 weeks, urticaria was reported in 28 patients treated in all ritlecitinib doses studied and 3 patients treated with placebo. The rate of urticaria was 8.23 per 100 patient-years in patients treated with LITFULO 50 mg and 4.03 per 100 patient-years in patients treated with placebo. Across clinical trials, including the long-term trial, urticaria was reported in 76 patients treated with LITFULO 50 mg or higher. Among all patients treated with LITFULO 50 mg or higher in the integrated safety analysis, the rate of urticaria was 4.10 per 100 patient-years.
The median time to onset of an initial event was 8 weeks; median duration of urticaria was 7 days. Most of the cases were mild to moderate in severity.
Decreased Lymphocyte Counts
Across clinical trials, including the long-term trial, confirmed ALC <500/mm3 occurred in 1 patient (<0.1%) treated with LITFULO 50 mg. Age appeared to be a risk factor for lower ALC in patients ≥65 years of age.
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.
DRUG INTERACTIONS
Effects of LITFULO on Other Drugs
CYP3A Substrates
Ritlecitinib is a CYP3A inhibitor. Concomitant use of ritlecitinib increases area under the curve (AUC) and Cmax of CYP3A substrates, which may increase the risk of adverse reactions of these substrates.
Consider additional monitoring and dosage adjustment in accordance with approved product labeling of CYP3A substrates where small concentration changes may lead to serious adverse reactions when used with LITFULO.
CYP1A2 Substrates
Ritlecitinib is a CYP1A2 inhibitor. Concomitant use of ritlecitinib increases AUC and Cmax of CYP1A2 substrates, which may increase the risk of adverse reactions of these substrates. Consider additional monitoring and dosage adjustment in accordance with the approved product labeling of CYP1A2 substrates where small concentration changes may lead to serious adverse reactions when used with LITFULO.
Effects of Other Drugs on LITFULO
CYP3A Inducers
Concomitant use of strong CYP3A inducer (e.g., rifampin) may decrease AUC and Cmax of ritlecitinib, which may result in loss of or reduced clinical response. Coadministration with strong inducers of CYP3A is not recommended.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Exposure Registry
If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940.
Risk Summary
Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures equal to 49 and 55 times the maximum recommended human dose (MRHD) based on an AUC comparison, respectively.
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 estimated 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.
Data
Animal Data
In an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the MRHD based on AUC comparison). Maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the MRHD based on AUC comparison). There was no developmental toxicity at 75 mg/kg/day (16 times the MRHD based on AUC comparison).
In an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic
arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the MRHD based on AUC comparison). There was no developmental toxicity at doses up to 25 mg/kg/day (12 times the MRHD based on AUC comparison).
In a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the MRHD based on AUC comparison). At 175 mg/kg/day (41 times the MRHD based on AUC comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. Bred females in the F1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day.
Lactation
Risk Summary
There are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Ritlecitinib is present in the milk of lactating rats. When a drug is present in animal milk, it is likely that it will be present in human milk. Because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with LITFULO and for approximately 14 hours after the last dose (approximately 6 elimination half-lives).
Data
After a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. The mean milk to plasma AUC ratio was determined to be 2.2.
Pediatric Use
The safety and effectiveness of LITFULO for alopecia areata have been established in pediatric patients ages 12 years and older. A total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (Trial AA-I). Efficacy was consistent between the pediatric patients and adults. The adverse reaction profile in the pediatric patients was similar to adults.
The safety and efficacy of LITFULO have not been established in pediatric patients under 12 years of age.
Geriatric Use
No dose adjustment is required for patients ≥65 years of age.
A total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. Clinical trials of LITFULO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Hepatic Impairment
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment.
OVERDOSAGE
LITFULO was administered in clinical trials up to a single oral dose of 800 mg. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetics data up to and including a single oral dose of 800 mg in healthy adult volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 48 hours.
There is no specific antidote for overdose with LITFULO. Treatment should be symptomatic and supportive, and monitor patients for signs and symptoms of adverse reactions.
In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.
This brief summary is based on LITFULOTM (ritlecitinib) Prescribing Information LAB-1469-0.5.
Issued: June 2023.
The product’s label may have been updated.
For full Prescribing Information, visit LITFULOHCP.com.
INDICATIONS AND USAGE
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.
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 CIBINQO® (abrocitinib) tablets, for oral use
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
CIBINQO®
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.
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
• Mortality
• Malignancy and Lymphoproliferative Disorders
Clinical Trials Experience
• Major Adverse Cardiovascular Events
• Thrombosis
• Laboratory Abnormalities
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
a Study size adjusted percentages b Herpes simplex also includes oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes.
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 200mg.
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.
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
Clinical Impact
Inhibitors
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 Impact
Coadministration of CIBINQO with P-gp 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 Impact
Coadministration of CIBINQO with antiplatelet 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.
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
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.
ACCESS DERMATOLOGY
A magazine dedicated to supporting patient access with practical information and lifestyle content
ISSUE 10 | 2024
MISSION STATEMENT:
Access Dermatology aims to educate and empower the biologic coordinator by keeping them informed of the complex and everchanging drug and patient access landscape. Readers are engaged with editorial and lifestyle content equally suitable for dermatologic patients, so they too may gain a better sense of therapies and the patient services programs that can assist in their therapeutic journey.
EXECUTIVE DIRECTOR
Craig Schuette
EDITOR
Elizabeth Hole
CREATIVE DIRECTOR
Venera Alexandrova
ASSISTANT ART DIRECTOR
Lisa Servidio
PRODUCTION DIRECTOR
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CORRESPONDENCE:
Communications regarding original articles as well as editorial suggestions for future issues should be addressed to Craig Schuette at cs@bcofdermatology.com. Any content forwarded to the publisher assumes no liability for the safety or return of unsolicited art, photographs, or manuscripts.
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Contact Craig Schuette at cs@bcofdermatology.com.
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MOFFLY CUSTOM MEDIA
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Tips to stay organized and offer high-quality care
44 Tricks of the Trade
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50 Best Foot Forward
How wide toe-box shoes are transforming our feet and overall health
52 From Clinic to Coordination
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A way to get patients started on treatment while they wait for appeals
Support through the prior authorization (PA) and appeals process
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Commercial Bridge Program*
Enhanced Services Specialty Pharmacy Network†
Advanced PA guidance
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.
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:
• Ac tive 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.
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.
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, 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.
Lactation
Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives). Please see Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.
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
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
atopic group, and 4% and at OPZELURA adverse 4 (1%)
Urticaria 3 (1%)
Adverse OPZELURA pyrexia, acneiform
Nonsegmental
TRuE-V2), vitiligo of subjects Asian. ≥ 1% and period any treatment 26 (6%) 5 (2%), site erythema
Adverse the OPZELURA hypertension, dermatitis influenza-like DRUG Drug known may increase decrease Strong inhibitors ruxolitinib
USE IN Pregnancy
Pregnancy outcomes persons exposure
Risk Summary are not other adverse of ruxolitinib adverse
The background populations other adverse birth defects Data Animal of organogenesis, rabbits. weight 60 mg/kg/day. systemic exposure affected lower fetal highest approximately study lactation embryofetal function
Lactation
Risk Summary on the of lactating present serious breastfeed last dose Data: (30 mg/kg) for up the maternal several
or with patients for treatment with opportunistic trials with kinase patients for OPZELURA (e.g., used to herpes inflammatory unknown. trials. elevations reported in is not inhibitor least one sudden inhibitor patient lymphomas, conditions. Malignancies, to treat an oral non-melanoma skin treated with the cancers those additional individual patients cancers), current or cell and Perform treatment as protective postmarketing least one (MACE) stroke Patients benefits and OPZELURA, other serious patients
OPZELURA. (PE), and used to serious and an oral cardiovascular compared to increased OPZELURA and , and benefits prior to indicated. If anemia, and increases (LDL) varying directly rates 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.
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
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.
CO-FOUNDER OF BCOD, GWU DEPARTMENT OF DERMATOLOGY, WASHINGTON, DC
WAYS TO USE AI IN OUR FIELD
In 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!
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.
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.
CAN YOU WALK US THROUGH THIS PROCESS STEP BY STEP?
6
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.
3 The AI company has access to our EMR, and a task is sent from the AI company confirming they have received the prescription. 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. 5 Prior Authorization is submitted from the AI company.
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.
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. 8 The appeal is submitted from Tandem. If approved, the AI company forwards the prescription to the mandated pharmacy through our EMR.
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.
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.
CONCLUSION
IS IT TRULY ALL “ROBOTIC” OR ARE THE COMPANY’S EMPLOYEES DOING ALL OF THIS?
Employees. I communicate with someone through tasks.
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!
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
• Have been prescribed OPZELURA according to the prescribing information
• Have tried and failed a topical medication
• Have been denied coverage for OPZELURA by their payer through a prior authorization (PA)
1. Send your prescription to a participating pharmacy (see QR code)
2. Provide the SP information required for a PA
3. Submit the PA to the payer per SP’s direction
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.
Get patients to the other side.
Scan the QR code or visit opzeluraontrachcp.com to find a participating Specialty Pharmacy.
Integrity Dr Madison, WI 53717 855-847-3553855-847-3558
Noble Health Services - Northeast 1750626453 6040 Tarbell Rd Syracuse, NY 13206
Noble Health Services - Southeast 1417469388 2506 Lakeland Dr, #201 Jackson, MS 39232
Polaris Specialty Rx1053486795 410 Cloverleaf Dr Baldwin Park, CA 91706
Professional Arts Specialty Pharmacy 1194890731 128 Curran Ln Lafayette, LA 70506
Quality Drug Clinical Care 1003698820 18 Technology Dr, #104 Irvine, CA 92618
Signio Specialty Pharmacy 1730515792
100 Enterprise Dr, #501 Rockaway, NJ 07866
888-843-2040888-842-3977
866-420-4041601-420-4040
Nationwide, Puerto Rico Does not ship to AR
Nationwide, Puerto Rico
Nationwide, Puerto Rico
626-626-9400800-540-3400Nationwide
888-237-4737855-724-6797Nationwide
833-210-5964833-210-5968
Nationwide, Puerto Rico Does not ship to AR
866-295-3015201-313-9798Nationwide
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:
• Ac tive 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.
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.
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, 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.
Lactation
Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives). Please see Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.
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].
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.
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
of endemic tuberculosis or endemic mycoses; or underlying conditions that may predispose them to infection. Closely monitor patients the development of signs and symptoms of infection during and after treatment OPZELURA. Interrupt OPZELURA if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume OPZELURA until the infection is controlled. : No cases of active tuberculosis (TB) were reported in clinical trials C ases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients administration of OPZELURA. During OPZELURA
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.
(TRuE-AD1 atopic group, and 4% and at OPZELURA adverse 4 (1%)
Urticaria 3 (1%)
: Viral reactivation, including cases of herpes virus reactivation herpes zoster), were reported in clinical trials with Janus kinase inhibitors used 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 O PZELURA initiation
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.
Adverse OPZELURA pyrexia, acneiform Nonsegmental TRuE-V2), vitiligo of subjects Asian. ≥ 1% and period any treatment 26 (6%) 5 (2%), site erythema
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 cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor
Consider the benefits and risks for the individual patient
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.
Malignancies, including lymphomas, inhibitors used to treat inflammatory conditions.
Adverse the OPZELURA hypertension, dermatitis influenza-like DRUG
Drug known may increase decrease
Strong inhibitors ruxolitinib
USE IN Pregnancy
Patients who are current or past smokers are at additional increased risk. Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to inflammatory conditions. In a large, randomized, postmarketing safety study of an JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma 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 A higher rate of lung cancers JAK inhibitor compared to 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), and patients who are current
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.
Pregnancy outcomes persons exposure
Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell squamous cell carcinoma have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment appropriate. Exposure to sunlight and UV light should be limited by wearing protective
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.
Risk Summary are not other adverse of ruxolitinib adverse
In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients 50 years of age and older with at least cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients Consider the benefits 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 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
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.
The background populations other birth defects Data
Animal of organogenesis, rabbits. weight 60 mg/kg/day. systemic exposure affected lower highest approximately study lactation embryofetal function
Thromboembolic events were observed in clinical trials with OPZELURA. Thrombosis, including deep vein thrombosis (DVT), pulmonary embolism (PE), arterial thrombosis have been reported in patients receiving JAK inhibitors used treat inflammatory conditions. Many of these adverse reactions were serious some resulted in death. In a large, randomized, postmarketing safety study of an 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 those treated with TNF blockers. Avoid OPZELURA in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue OPZELURA
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
T hrombocytopenia, anemia 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 initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. signs and/or symptoms of clinically significant thrombocytopenia, anemia,
Lactation
Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein
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
Risk Summary on the of lactating present serious breastfeed last dose Data: (30 mg/kg) for up the maternal several
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 Atopic Dermatitis: In two double-blind, vehicle-controlled clinical
(TRuE-AD1 and TRuE-AD2), 499 adult and pediatric subjects 12 years of age and older with dermatitis were treated with OPZELURA twice daily for 8 weeks. In the OPZELURA 62% of subjects were females, and 71% of subjects were White, 23% were Black, 4% were Asian. The adverse reactions reported by ≥ 1% of OPZELURA treated subjects 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 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 vs 0 (0%), and Rhinorrhea 3 (1%) vs 1 (<1%).
(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.
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 TRuE-V2), 449 adult and pediatric subjects 12 years of age and older with nonsegmental were treated with OPZELURA twice daily for 24 weeks. In the OPZELURA group, 55% subjects were females, and 81% of subjects were White, 5% were Black, and 4% were The adverse reactions reported by OPZELURA and at least 1% greater incidence than in the vehicle arm in the 24-week double-blind are as follows for OPZELURA (N=449) vs Vehicle (N=224), respectively: Subjects with treatment emergent adverse event (TEAE) 214 (48%) vs 79 (35%), Application site acne (6%) vs 2 (1%), Application site pruritus 23 (5%) vs 6 (3%), Nasopharyngitis 19 (4%) vs (2%), Headache 17 (4%) vs 6 (3%), Urinary tract infection 7 (2%) vs 1 (<1%), Application erythema 7 (2%) vs 1 (<1%), and Pyrexia 6 (1%) vs 0 (0%)
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 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.
INTERACTIONS
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
interaction studies with known to be a substrate for cytochrome P450 3A4 increase ruxolitinib systemic concentrations whereas inducers of decrease ruxolitinib systemic concentrations.
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.
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.
IN SPECIFIC POPULATIONS
Pregnancy
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Exposure Registry utcomes 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.
Summary
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.
not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity. background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or adverse outcomes. The background risk in the U.S. general population of major defects and miscarriage is 2-4% and 15-20%, respectively.
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
Data: Ruxolitinib was administered orally to pregnant rats or rabbits during the period organogenesis, at doses of 15, 30 rabbits. There were no treatment-related malformations at any dose. A decrease in fetal of approximately 9% was noted in rats at the highest and maternally toxic dose of 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 fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of approximately 70% the MRHD clinical systemic exposure. In a pre-and post-natal development 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
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
Summary breastfed child, or the effects on milk production. Ruxolitinib was present in the milk 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 dose (approximately
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).
Lactating rats were administered a single dose of [14C]-labeled ruxolitinib mg/kg) on postnatal Day 10, after which plasma and milk samples were collected to 24 hours. The AUC for total radioactivity in milk was approximately 13 times 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.
or with patients for treatment with opportunistic trials with kinase patients for OPZELURA reactivation (e.g., used to herpes inflammatory unknown. trials. elevations reported in is not inhibitor least one sudden inhibitor patient lymphomas, conditions. Malignancies, to treat an oral non-melanoma skin treated with the cancers those additional individual patients cancers), current or cell and Perform treatment as protective postmarketing least one (MACE) stroke Patients benefits and OPZELURA, other serious patients OPZELURA. (PE), and used to serious and an oral cardiovascular compared to increased OPZELURA and anemia , and benefits prior to indicated. If anemia, and increases (LDL) varying directly rates clinical trials
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.
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
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.
BENEFITS YOU CAN EXPECT
NEW LEARNING PATHS
Customized sessions for every career phase
HANDS-ON WORKSHOPS
Interact with experts to improve your skills
EXCLUSIVE EARLY BIRD SPECIAL:
CAREER GROWTH
Elevate your career with cutting-edge knowledge
NETWORKING
Connect with peers and industry leaders in an engaging environment
Be one of the first 100 members to register and book your hotel room to receive exclusive BCoD or FIGS gear. Don’t miss the chance to enhance your conference experience with these special perks!
NEED ANOTHER REASON TO ATTEND THE BCOD NATIONAL CONFERENCE THIS YEAR?
NEED ANOTHER REASON TO ATTEND THE BCOD NATIONAL CONFERENCE THIS YEAR?
BCOD MASTERCLASS:
BCOD MASTERCLASS:
New this year, we are introducing a special workshop, the BCoD Masterclass, focused on reducing script fulfillment delays, promoting team communication, and enhancing patient satisfaction. Attendees will receive a Biologic Binder, a valuable resource for office staff to facilitate drug approvals and enhance documentation within EHR systems.
New this year, we are introducing a special workshop, the BCoD Masterclass, focused on reducing script fulfillment delays, promoting team communication, and enhancing patient satisfaction. Attendees will receive a Biologic Binder, a valuable resource for office staff to facilitate drug approvals and enhance documentation within EHR systems.
ENHANCING OFFICE WORKFLOWS:
ENHANCING OFFICE WORKFLOWS:
The training session aims to establish and enhance office workflows to ensure efficient drug fulfillment. This includes optimizing processes and protocols for faster medication approvals.
The training session aims to establish and enhance office workflows to ensure efficient drug fulfillment. This includes optimizing processes and protocols for faster medication approvals.
TEAM COHESION:
TEAM COHESION:
BCoD will guide practices in fostering cohesive teamwork within the office. This teamwork is crucial for streamlining operations and reducing delays in patient care.
BCoD will guide practices in fostering cohesive teamwork within the office. This teamwork is crucial for streamlining operations and reducing delays in patient care.
UTILIZATION OF TECHNOLOGY PLATFORMS:
UTILIZATION OF TECHNOLOGY PLATFORMS:
Drawing on experience with EMA, Epic, and other tech platforms, the session will provide insights into leveraging these tools effectively. This can significantly contribute to reducing administrative burdens and improving efficiency.
Drawing on experience with EMA, Epic, and other tech platforms, the session will provide insights into leveraging these tools effectively. This can significantly contribute to reducing administrative burdens and improving efficiency.
COMPREHENSIVE TRAINING MATERIALS:
COMPREHENSIVE TRAINING MATERIALS:
Participants will receive comprehensive materials and guides covering brand-specific approval documents, EMR setup instructions, process and protocol best practices, and biosimilar drug lists. These resources are designed to equip staff with the necessary knowledge to expedite medication processes.
Participants will receive comprehensive materials and guides covering brand-specific approval documents, EMR setup instructions, process and protocol best practices, and biosimilar drug lists. These resources are designed to equip staff with the necessary knowledge to expedite medication processes.
BIOLOGIC BINDER:
BIOLOGIC BINDER:
Attendees will receive robust biologic binder, which includes never-before-seen content. This binder aims to serve as a practical tool for offices and new staff, providing readily accessible information to further optimize medication management.
Attendees will receive a robust biologic binder, which includes never-before-seen content. This binder aims to serve as a practical tool for offices and new staff, providing readily accessible information to further optimize medication management.
COST-EFFECTIVE TRAINING OPPORTUNITY:
COST-EFFECTIVE TRAINING OPPORTUNITY:
Unlike similar market programs that can cost over $1,000, BCoD’s workshop is offered at no cost to conference attendees. This makes high-quality training accessible to all BCs, thereby potentially benefiting more dermatology practices.
Unlike similar market programs that can cost over $1,000, BCoD’s workshop is offered at no cost to conference attendees. This makes high-quality training accessible to all BCs, thereby potentially benefiting more dermatology practices. Join BCoD and attend our 2024 National Conference for this masterclass and many additional empowering workshops and presentations.
MEDICAL SCIENCE LIAISON
EXPERTS PROVIDE RESOURCES AND SUPPORT
It 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)?
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).
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/
“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").
*DISCLAIMER
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/
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.
Once a prescribing decision has been made to prescribe TREMFYA® (guselkumab), enroll patients in
A dedicated support program for TREMFYA® patients
TREMFYA withMe provides a range of dedicated support to help make it easier for patients as they begin, and continue, their TREMFYA® treatment journey.
If a patient has been prescribed TREMFYA® for approved on-label use and is 18 or older, they are eligible for this program.
Here’s how you can sign up patients. Scan or Visit: Visit tremfyawithme.com/ healthcare-professionals to sign up patients and for more information. Scan this QR CODE with your phone’s camera
Actor Portrayal
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.
ACCESS
MANAGEMENT
TIPS TO STAY ORGANIZED AND OFFER HIGH-QUALITY CARE
By Alisa Redmon
“For every minute spent organizing, an hour is earned.”
–BENJAMIN FRANKLIN
You’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.
WHAT INFORMATION IS MOST IMPORTANT TO KNOW ABOUT EACH PATIENT?
THE BASICS
Name, date of birth, contact information, medication
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.
COVERAGE
Determination status and assistance status
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.
“All worries are less with cheese.”
– AMIT KALANTRI
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.
1. Reason JT. Human Error. Cambridge, England: Cambridge University Press. 1990
SPECIALTY PHARMACIES: TO UTILIZE OR NOT
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.
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.
HELPFUL TIPS
1. PATIENT EDUCATION
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.
5. FIND YOUR COMMUNITY
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.
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.
TRICKS OF THE TRADE
Kalie Carlton
Office Manager, NORTHERN NURSE PRACTITIONERS
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.
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.
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.
To have a routine or steps, follow with each biologic start. That really helps to make sure you don't forget something.
Stay in communication with the patient until medication is in their hands. Lack of communication is how patients will fall through the cracks.
Talisa Soto
Biologic Coordinator, CHICAGO SKIN CLINIC
TRICKS OF THE TRADE
I created a bilingual Checklist/FAQ sheet to aid patients in understanding the process while they wait for medication approval.
Jennifer Reyes
Biologics Coordinator, CATSKILL DERMATOLOGY
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
Biologic Coordinator, DALTON DERMATOLOGY AND DAY SPA
Keep patients updated. If the patients know what is going on, you will have fewer phone calls and happier patients.
Review pending PAs and PAP often. This ensures the requests were received for review and that decisions are received in a timely manner.
Always remember no matter how complex and tough the process may be, the approval for the patient is always worth it in the end.
Krystal Clayton
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.
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
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%).
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.
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 7 (1.5)
1 (0.4)
Nausea 6 (1.3) 0 (0)
Headache 5 (1.1) 0 (0)
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 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).
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.
By Georgette Yacoub
by Kasandra Barton
Best Foot
Humans 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.”
Illustrations
healthy toes
Forward
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
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
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.
“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.
hammer toe
claw toe
By Darla Hobbs MEDICAL ASSISTANT AND BIOLOGIC COORDINATOR, LOCKHART MATTER DERMATOLOGY
FROM CLINIC
BALANCING DUAL ROLES OF CLINICAL MEDICAL ASSISTANT AND BIOLOGIC COORDINATOR
As 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.
TO
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.
COORDI
NATION
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.
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.
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.
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.
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.
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.
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.
By Carolyn Williams BIOLOGIC COORDINATOR, PIEDMONT PLASTIC SURGERY & DERMATOLOGY
Hidradenitis Suppurativa
WHAT IS IT AND HOW CAN IT BE TREATED?
As 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.
EXPERT INTERVIEW
& Q A
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.
WHAT IS HIDRADENITIS SUPPURATIVA?
HS is a lifelong condition.
The biggest mistake people make is treating their HS only for flares or for short periods of time.
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
respond well to medical treatment and the tunnels will need to be removed surgically.
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.
TOGETHER WE ADVANCE PATIENT
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
Exclusive invites to educational trainings, webcasts, and meetings. RESOURCES
Office and patient resources for easier approvals and workflow management.
PROFESSIONAL DEVELOPMENT
Content designed for personal and professional growth. IMPROVE PATIENT OUTCOMES
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
By Liz Barron
Real Talk
BUSY MOM AND CONTENT
CREATOR MEGAN
SCHINELLA JOINS NEW PODCAST "ROOM 4 FOUR"
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.
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
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.
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
Kallie Branciforte, Caitlin Houston, Megan Schinella and Charlotte Smith on the set of their new podcast, Room 4 Four.
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.”
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
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
in our home is healthy, that’s all that matters,” she adds.
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.
above: Joseph, Nico, Ava, Gianna and Megan Schinella
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