Clinical Alert- August 2022

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DEPUTY EDITORS Jessica Czechowski PharmD Carole Kerzic RPh Leslie Pittman PharmD Devon Trumbower PharmD, BCPS




The US FDA has announced revisions to the EUA for ritonavir-boosted nirmatrelvir (Paxlovid) to allow statelicensed pharmacists the authority to prescribe Paxlovid to eligible patients under certain circumstances. In the event of a positive COVID-19 test, the FDA instructs patients to first utilize their regular HCP or locate a Testto-Treat site, if available. In an effort to expand access to Paxlovid, the EUA updates allow retail pharmacies not currently participating in the Test-to-Treat program to have state-licensed pharmacists prescribe Paxlovid; however, certain limitations apply. Prior to prescribing, the state-licensed pharmacist is required to have adequate information to assess the patient’s eligibility for Paxlovid. This includes recent (< 12 months old) health record information with laboratory values to assess renal and hepatic function as well as a current, comprehensive medication list, including OTC drugs. Referral to a physician, physician assistant, or APRN is required, if the pharmacist does not have adequate information to evaluate renal and hepatic function, to assess for potential drug interactions, or if changes in drug therapy are needed in order to safely use Paxlovid.

The FDA is planning to convene the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on October 17th to 19th of this year for a hearing on hydroxyprogesterone caproate injection (Makena). In August 2021, the FDA ordered a hearing would be granted on the proposed withdrawal of the product and 5 generic versions. This followed the 2020 request by the manufacturer for a hearing after the FDA proposed withdrawal of the drug’s approval and issuance of a Notice of Opportunity for a Hearing. In 2019, an FDA Advisory Committee voted 9 to 7 for withdrawal based on results of the PROLONG study. Makena is currently the only FDA-approved therapy to decrease the risk for preterm birth in women with a singleton pregnancy and a history of spontaneous singleton preterm birth. The final decision regarding Makena remaining on the market will occur after the October 2022 hearing.

Additionally, to be eligible for Paxlovid, patients are required to meet the criteria in the HCP Fact Sheet. Paxlovid is authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (≥ 12 years old weighing ≥ 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid treatment should be started as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. Patients who report a positive home test result (rapid antigen or PCR) to their HCP are eligible for Paxlovid; confirmation testing is not required. The EPIC-HR study demonstrated an 86% relative risk reduction for hospitalization or death from any cause with Paxlovid compared to placebo. In June, Pfizer announced submission of an NDA to the FDA for approval of the agent. 2 | AUGUST 2022

COVID-19: NOTABLE DEVELOPMENTS The FDA has issued an EUA for the adjuvanted Novavax COVID-19 vaccine for prevention of COVID-19 caused by SARS-CoV-2 in those ≥ 18 years old. It is administered as a 2-dose IM (0.5 mL per dose) primary series with the doses separated by 3 weeks. An ongoing, randomized, placebo-controlled study demonstrated vaccine efficacy of 90.4% for prevention of mild, moderate, or severe COVID-19 and vaccine efficacy of 78.6% in those ≥ 65 years old. FDA approval has been granted to the Pfizer/Biontech COVID-19 vaccine, Comirnaty®, for use in individuals 12 through 15 years of age for prevention of COVID-19. The vaccine was previously only approved for use in individuals ≥ 16 years old, but carries an EUA for use in those ≥ 6 months of age. The HCP Fact Sheet for tixagevimab co-packaged with cilgavimab (Evusheld™) has been revised to recommend repeat dosing every 6 months (dose of 300 mg of tixagevimab and 300 mg of cilgavimab), if ongoing protection is needed. Please refer to the COVID-19 disclaimer at the end of the publication.


HAPPENINGS & HIGHLIGHTS • Mylan is voluntarily recalling 1 batch (NDC 495020394-75; BF21002895; expiration 8/2023) of unbranded insulin glargine-yfgn 3 mL prefilled pens due to the potential for the label to be missing on some pens. This recall is at the wholesaler, retailer, and consumer levels. Product is packaged in cartons of 5 pens and was distributed between April 4, 2022 and May 5, 2022. • Due to the Rx-to-OTC switch of Nasonex® 24HR Allergy (mometasone furoate), indications for the treatment of nasal symptoms of allergic rhinitis and nasal congestion associated with seasonal allergic rhinitis in patients ≥ 2 years old have been removed from Rx labeling. Remaining indications for Rx Nasonex are prophylaxis of nasal symptoms of seasonal allergic rhinitis in patients ≥ 12 years old and the treatment of chronic rhinosinusitis with nasal polyps in adults. The OTC version by Perrigo is labeled for temporary relief of symptoms due to hay fever or other upper respiratory allergies.

• The FDA has issued a drug safety communication on the increased risk of death with duvelisib (Copiktra®) compared to ofatumumab (Kesimpta®) observed in a clinical trial. A higher risk of serious side effects was also associated with use of duvelisib. The FDA intends to hold a public meeting to review the safety concerns and evaluate if duvelisib should remain on the market. The kinase inhibitor is indicated for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after ≥ 2 prior therapies. • Alfasigma announced the withdrawal of tegaserod (Zelnorm®) from the market. Tegaserod was initially approved in 2002 and withdrawn voluntarily in 2007 due to CV safety issues. It was made available again in August 2019 for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women ≤ 65 years old. The withdrawal, effective June 30, 2022, was due to a business-related decision and not based on efficacy or safety issues.

DRUG INFORMATION HAPPENINGS • The CDC has published interim recommendations from ACIP for Moderna and Pfizer/Biontech COVID-19 vaccines in children 6 months to 5 years old in the MMWR. The CDC has also endorsed ACIPs’ recommendation on the Novavax COVID-19 vaccine as another primary series option for adults. • The CDC has published a special report detailing the impact COVID-19 has had on antimicrobial resistance. • The FDA has published the 2021 calendar year report on drug shortages. • The FDA has released a 5-year action plan for supporting the development of medical therapies for rare neurodegenerative diseases, including ALS. • The US Preventive Services Task Force (USPSTF) has published final recommendations on vitamin, mineral, and multivitamin supplementation for prevention of CVD and cancer for community-dwelling, nonpregnant adults. Beta-carotene or vitamin E supplements are recommended against for the prevention of CVD or cancer (Grade D). Evidence is inadequate to determine the benefits versus harms of multivitamin supplements for prevention of CVD or cancer (Grade I). Evidence is also inadequate to determine the benefits and harms of use of single or paired nutrient supplements (other than aforementioned beta carotene and vitamin E) for prevention of CVD or cancer (Grade I).







adalimumab 100 mg/mL (biosimilar to Abbvie’s Humira®) Celltrion

• SC • Tumor necrosis factor-alpha (TNF-α) inhibitor


August 2022

trastuzumab (biosimilar to Genentech’s Herceptin®) Tanvex

• IV • Anti-human epidermal

Breast cancer; Gastric/ gastroesophageal cancer

August 2022

teclistamab Janssen

• SC • Anti-B cell maturation antigen (BCMA) antibody

Multiple myeloma (R/R)

Aug–Dec 2022

pimavanserin (Nuplazid®) Acadia

• Oral • Atypical antipsychotic

Alzheimer’s disease-related hallucinations and delusions


relugolix/estradiol/norethindrone (Myfembree®) Myovant

• Oral • estrogen/gonadotropinreleasing hormone (GnRH) antagonist/progestin



betibeglogene autotemcel Bluebird Bio

• IV • Gene therapy

β-thalassemia (transfusiondependent)


miglustat Amicus

• Oral • Glucosylceramide synthase inhibitor

Pompe disease (used in combination with cipaglucosidase alfa)


4 | AUGUST 2022

growth factor receptor 2 (HER2) antibody




New Drugs zonisamide (Zonisade™) Azurity

• 505(b)(2) NDA approval 07/15/2022; Standard Review • Indicated as adjunctive therapy for the treatment of partial-onset seizures in

adults and pediatric patients ≥ 16 years old

• Anticonvulsant • Oral suspension: 100 mg/5 mL • Recommended initial dosage is 100 mg daily with or without food; based on

response and tolerability, the dosage can be increased by 100 mg daily every 2 weeks to 400 mg daily; if additional response is needed, those who tolerate 400 mg daily can be increased up to a maximum dosage of 600 mg daily

testosterone undecanoate (Kyzatrex®) Marius

• 505(b)(2) NDA approval 07/27/2022; Standard Review • Indicated for testosterone replacement therapy in adult males for conditions

• • • •

• •

associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism and hypogonadotropic hypogonadism Safety and efficacy in males < 18 years old have not been established Androgen Oral capsule: 100 mg, 150 mg, 200 mg; not substitutable with other oral testosterone undecanoate products Recommended starting dosage is 200 mg twice daily with food; the dosage is adjusted based on serum testosterone levels 3 to 5 hours following the morning dose ≥ 7 days after starting treatment or after dose adjustments (minimum dose: 100 mg once in the morning; maximum dose: 400 mg twice daily) Boxed warning for blood pressure increases that may contribute to the risk of major adverse cardiovascular events Schedule III controlled substance

505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

COVID-19 Disclaimer: For more resources on COVID-19, visit the Magellan Rx Coronavirus Update webpage. For the most current information, visit the FDA, CDC, NIH, NIH guidelines, and WHO websites. State and local health departments also provide valuable information regarding management in local communities. As the COVID-19 landscape is fluid, assumptions are subject to change. Glossary: ACIP Advisory Committee on Immunization Practices

FDA Food and Drug Administration

PSO plaque psoriasis

ALS amyotrophic lateral sclerosis

HCP healthcare professional

R/R relapsed or refractory

IM intramuscular

RA rheumatoid arthritis

IV intravenous

Rx prescription

JIA juvenile idiopathic arthritis

SARS-CoV-2 severe acute respiratory syndrome coronavirus 2

APRN advanced practice registered nurse AS ankylosing spondylitis BLA Biologics License Application

MMWR Morbidity and Mortality Weekly Report

CD Crohn’s disease CDC Centers for Disease Control and Prevention COVID-19 Coronavirus Disease 2019 CV cardiovascular CVD cardiovascular disease EUA Emergency Use Authorization

NDA New Drug Application NDC National Drug Code NIH National Institutes of Health OTC over-the-counter PCR polymerase chain reaction PsA psoriatic arthritis


6 | AUGUST 2022

© 2022, Magellan Health. All rights reserved.

SC subcutaneous UC ulcerative colitis US United States WHO World Health Organization

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