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Pulse Newsletter

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

Volume 5 | Issue 14
August 15, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

Beyfortus™ Approved for Prevention of RSV in Babies and Toddlers

On July 17, 2023, the U.S. Food and Drug Administration (FDA) announced its approval of AstraZeneca’s Beyfortus™ for the prevention of Respiratory Syncytial Virus (RSV) infection in babies and toddlers. RSV is a common respiratory virus that may cause mild, cold-like symptoms in many people. Infants and older adults are at an increased risk of severe RSV infection that may lead to lower respiratory tract diseases, such as pneumonia or bronchiolitis and hospitalization. Approximately 1-3% of children under the age of one are hospitalized due to RSV annually. Rates of RSV infections begin to rise in early autumn and peak in the winter. The upcoming RSV season will be the first in the United States with preventative pharmaceuticals available for high-risk groups of infants, toddlers and older adults. In May 2023, the FDA approved two RSV vaccines, Arexvy® and Abrysvo®, for adults 60 and older. Now, the approval of Beyfortus™ addresses the need for prevention in infants. It is indicated for neonates and infants born during or entering their first RSV season and children up to 2 years old who may still be at risk of severe RSV infection entering their second RSV season. The Centers for Disease Control and Prevention (CDC) recommends Beyfortus™ for all infants younger than 8 months of age. Beyfortus™ is not a vaccine; it is a monoclonal antibody product administered as a single intramuscular injection. Vaccines usually administer a virus or virus-like product into a patient, prompting their immune system to make antibodies to protect against that virus. In contrast, patients receiving Beyfortus™ will acquire an antibody already prepared to bind to and block the RSV virus. The safety and efficacy of Beyfortus™ was demonstrated in 3 clinical trials of children up to 2 years old. Participants receiving Beyfortus™ showed a decrease in all health care provider visits by up to 75% compared to those receiving placebo. These health care provider visits included all physician, urgent care and emergency room visits and hospitalizations related to worsening symptoms and a positive RSV test. Possible side effects of Beyfortus™ include rash and injection site reactions. Caution should be used in patients with significant bleeding disorders or a history of serious allergic reactions to monoclonal antibodies. 

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Drug Safety

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Tydemy™ Oral Contraceptive

Lupin Pharmaceuticals, Inc. announced a voluntary recall of two lots of Tydemy™, an estrogen/progestin oral contraceptive used to prevent pregnancy and raise folate levels. These two lots were recalled due to reduced levels of ascorbic acid and increased impurities in the product. Reduction of ascorbic acid in the product could make Tydemy™ less effective, potentially leading to unexpected pregnancy in patients. Distributors and pharmacies have been made aware of this recall and have been instructed to return the recalled lots of this product to the company. Patients are advised to continue use of Tydemy™, but they should also contact their health care provider or pharmacist immediately regarding alternative treatment options. There have been no reports of adverse reactions to date, but patients are instructed to report any they may have experienced to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

Second OTC Naloxone Spray Approved for Opioid Overdose

On July 28, 2023, the FDA approved RiVive™ (naloxone hydrochloride) 3 mg nasal spray for use without a prescription. It is the second over the counter (OTC) naloxone product approved for the emergency treatment of known or suspected opioid overdose. Naloxone rapidly reverses the effects of opioids, and prompt administration of the drug can rescue an individual suffering an opioid overdose from death. Studies showed that RiVive™ reaches the bloodstream at a level comparable to that achieved by an approved prescription naloxone product, and studied consumers demonstrated an understanding of how to use the drug safely and effectively without a health care professionals’ supervision. Drug overdose is a major public health issue in the U.S., and the OTC availability of naloxone products may help increase access and protect the health of consumers. There are no risks when administering naloxone to individuals who haven’t taken opioids, so it can be administered whenever an opioid overdose is suspected. The pricing and availability of RiVive™ is not yet known but is anticipated for early 2024 as determined by the manufacturer, Harm Reduction Therapeutics, Inc. Harm Reduction Therapeutics, Inc. will also make at least 200,000 doses available free of charge to consumers.

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FDA Approvals

New FDA Approvals

New Drug: VANFLYTA® (quizartinib dihydrochloride)

Oral tablets approved for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML). [07/20/2023 - DAIICHI SANKYO, INC.]    

New Drug: XDEMVY™ (lotilaner)

Eye drops approved for the treatment of adult patients with Demodex blepharitis, a bacterial infection caused by mites. [07/24/2023 - TARSUS PHARMACEUTICALS, INC.]

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New Generics

New Generics Entering the Marketplace

ONGLYZA® (saxagliptin)

Indication: Used with diet and exercise to improve glucose control in adult patients with type 2 diabetes mellitus.

Dosage Form/Strength: 2.5mg, 5mg oral tablets

Average Wholesale Price (AWP): Generic = $524 | Brand = $582