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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 15
August 1, 2022

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves the First Topical Treatment Addressing Repigmentation in Vitiligo Patients  

On July 19, 2022, the FDA approved Opzelura® (ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years and older. It is the first FDA-approved medication to address repigmentation in vitiligo patients. Nonsegmental vitiligo is the most common form of vitiligo, and the condition involves a loss of pigment in patches of skin on the face, neck, scalp and around body openings such as mouth and genitals. It can also involve areas that tend to experience rubbing or impact, such as hands and arms. Vitiligo is a form of an autoimmune disorder when the immune system attacks the pigment cells in the skin. Opzelura® is a topical Janus kinase (JAK) inhibitor that blocks enzymes involved in activating immune cells. Opzelura® is also indicated for mild to moderate atopic dermatitis in select patients, ages 12 years and older. Two clinical trials were conducted to test the safety and effectiveness of Opzelura® in the treatment of nonsegmental vitiligo. In both trials, patients with the condition were randomized to treatment with Opzelura® or placebo cream twice daily for 24 weeks, followed by an additional 28 weeks of treatments during which all patients received Opzelura®. By the end of the initial 24-week treatment period, 30% of Opzelura® patients had at least 75% improvements in the facial Vitiligo Area Scoring Index, compared with 10% of placebo patients. Common adverse reactions to Opzelura® are application site acne, itching or redness, as well as common cold, headache, UTI, and fever. The use of Opzelura® in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

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Drug Safety

FDA Announces Insulin Recall Due to Missing Labels 

On July 5, 2022, Mylan Pharmaceuticals Inc. voluntarily recalled one batch of their Insulin Glargine injection pens due to potentially missing labels on some devices. These devices are 100 unit/mL, 3 mL prefilled pens which are packaged and distributed to patients in cartons of five pens. Insulin Glargine is a long-acting insulin used to improve blood glucose levels in adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Many patients use both a short-acting and a long-acting insulin injectable in their diabetes mellitus therapy. The missing labels on these Insulin Glargine pens could put these patients at risk of mixing up various products and strengths, leading to altered control of their blood glucose. These mislabeled products were manufactured by Biocon Sdn Bhd and distributed by Mylan Specialty LP. The company has notified distributors, retailers and consumers regarding the recall. Consumers who have received the recalled product should contact Sedwick at 1-877-643-8438 to return any unlabeled products. Affected consumers should report any adverse reactions or quality problems to their physician/health care provider as well as FDA's MedWatch. To date, Mylan has not received any reports of adverse events related to this recall.

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From the Pharmaceutical Industry

FDA Authorizes Pharmacists to Prescribe Oral COVID-19 Medication, Paxlovid™

On July 6, 2022, the U.S. Food and Drug Administration (FDA) authorized state licensed pharmacists to prescribe Paxlovid to eligible patients. Paxlovid must be taken within the first five days after symptom onset, so allowing pharmacists to prescribe the medication will vastly expand access to appropriate and timely treatment for all eligible patients. Paxlovid is authorized to treat mild to moderate symptoms in COVID-19 positive patients in both adults and pediatric patients (age ≥12 and weight ≥88 pounds). Paxlovid is for patients who are at high risk for progressing to severe COVID-19, including hospitalization and death. Eligibility for Paxlovid is determined by the pharmacist by viewing the positive results from a home rapid antigen test or a laboratory PCR test. COVID positive patients should bring the following information to their state licensed pharmacist to determine their eligibility: printed or electronic health records (within the past year, including most recent blood work) and a list of the medications they are taking, including prescription and over-the-counter products. The medical records may be received through the patient’s health care provider if the patient is unable to access them. Some limitations to the pharmacists’ prescribing powers have been outlined by the FDA. The pharmacist should refer the patient to a physician, nurse practitioner or physician assistant to evaluate eligibility in the following circumstances: if kidney and liver function cannot be adequately assessed, sufficient information is not available to identify potential drug interactions, modifications must be made to another medication due to a drug interaction with Paxlovid or if Paxlovid is not an appropriate option.

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FDA Approvals

New FDA Approvals

New Dosage Form:  Zonisade (zonisamide)
Oral suspension approved for treatment of partial-onset seizures in adults and pediatric patients 16 years and older. [07/15/2022 – AZURITY]

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New Generics

New Generics Entering the Marketplace

Pradaxa® (dabigatran etexilate mesylate)
Indication: Blood clot prevention
Dosage Form/Strength: 75 MG, 100 MG, 150 MG Capsules
Average Wholesale Price (AWP): Generic = $267 | Brand = $297