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Pulse Newsletter

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

Volume 3 | Issue 4
February 14, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Update

FDA Approves First Extended-Release, Injectable Drug Regimen for Patients Living with HIV

On January 21, 2021, the U.S. Food and Drug Administration (FDA) approved Cabenuva® (cabotegravir/rilpivirine) injection for the treatment of human immunodeficiency virus type 1 (HIV-1). Cabenuva®, administered intramuscularly once a month, is a complete treatment regimen for HIV-1 that is meant to replace a patient’s current antiviral therapy regimen, which typically consists of multiple oral tablets taken daily. In order to become eligible for a switch to Cabenuva®, a patient must be in a state of virological suppression, which signifies a low level of HIV-1 in the blood and indicates a positive response to antiviral therapy. Tolerability to Cabenuva® is first assessed by trialing patients with a month-long lead-in of oral Vocabria® (cabotegravir) and oral Edurant® (rilpivirine). On the last day of the trial of oral medication, Cabenuva® injection is initiated with a starting dose of 600 MG cabotegravir and 900 MG of rilpivirine. Injections continue every month with a maintenance dose of 400 MG of cabotegravir and 600 MG of rilpivirine. Data from two clinical trials were used to establish the safety and efficacy of Cabenuva®. Through the trials, it was found that 1,182 HIV-infected adults who were virologically suppressed before starting Cabenuva® continued to successfully show virological suppression at the conclusion of each study. The most common side effects were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, and rash. Individuals who cannot tolerate cabotegravir or rilpivirine, or whose HIV-1 is not virally suppressed should not use Cabenuva®

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Safety First

Apotex Corp. Issues Voluntary Recall of Enoxaparin Due to Mislabeling

On February 3, 2021, the FDA released information regarding Apotex Corp.’s voluntary recall of two batches of enoxaparin sodium injection due to a packaging error. A customer complaint revealed a labeling error where syringe barrels containing a drug concentration of 100 mg/mL were incorrectly labeled with a concentration of 150 mg/mL on the barrel, and vice versa. Enoxaparin is an anticoagulant that is used to prevent the formation and growth of blood clots that may lead to adverse events such as heart attack, stroke or pulmonary embolism. An overdose of enoxaparin may lead to an increased risk for bleeds, while an inadequate dose of enoxaparin may result in a patient developing serious blood clotting conditions. Patients who have received medication from either of the two batches being recalled should contact their health care provider immediately and -are advised not to discontinue or alter their treatment in any way prior to speaking with their provider. Apotex Corp. is arranging the return of all recalled product from all wholesalers, distributers and retailers. To date, no adverse events related to the mislabeled batches have been reported to Apotex. Adverse reactions or quality problems should be reported to the FDA’s MedWatch Adverse Event Reporting Program. Questions regarding the recall can be made directly to Apotex Corp. by phone or email.

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From the Industry

Pfizer’s Xeljanz Fails RA Safety Study

Xeljanz® (tofacitinib), a JAK inhibitor indicated for the treatment of Rheumatoid Arthritis (RA) and other autoimmune diseases, has faced some scrutiny related to possible cardiovascular side effects and increased cancer risk associated with its use. JAK inhibitors, which transformed the market by offering an oral dosage form, are part of a class of medications known as disease-modifying antirheumatic drugs (DMARDs). Another class of medications used to treat RA, called TNF inhibitors (TNFi), are another type of DMARD, which are often administered by injection. Both classes are typically turned to when a patient fails one or more conventional, first-line agents, such as methotrexate. In 2019, the FDA added a boxed warning denoting increased risk of blood clots for individuals taking Xeljanz®. Now, the FDA may look to impose additional prescribing restrictions as a result of new data released from a longterm safety trial which showed that Xeljanz® did not meet the trial’s primary safety endpoints when compared to various TNFis. The ongoing safety concerns associated with Xeljanz® will need to be addressed by Pfizer as it continues to face steep competition amongst the growing number of new medications used to treat RA.

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FDA Approvals

Recent FDA Approvals

Novel Drug Approval: Cabenuva™ (cabotegravir/rilpivirine)
Intramuscular suspension approved for the replacement of a current antiretroviral regimen in adult patients infected with HIV-1 that are stable and have no history of treatment failure [1/21/21 – Fast TrackPriority Review – VIIV HEALTHCARE]

Novel Drug Approval: Lupkynis™ (voclosporin)
Oral capsule approved for the treatment of adult patients with active lupus nephritis, in combination with a background immunosuppressive therapy regimen [1/22/21 – Priority Review – AURINIA PHARMACEUTICALS, INC]

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New Generics

New Generics Entering the Marketplace

Truvada® (emtricitabine/tenofovir disoproxil fumarate)
Indication: Pre-Exposure Prophylaxis (PrEP) and treatment of HIV-1 infection
Dosage Form/Strength: 100/150, 133/200, 167/250 MG Oral tablet
Average Wholesale Price (AWP): Generic = $2,100 | Brand = $2,211

Zomig® (zolmitriptan)
Indication: Acute treatment of migraine with or without aura
Dosage Form/Strength: 2.5, 5 MG Intranasal solution
Average Wholesale Price (AWP): Generic = $669 | Brand = $704