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Pulse Newsletter

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

Volume 6 | Issue 8
April 15, 2024

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

Clinical Pharmacy Update

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

On March 21, 2024, the U.S. Food and Drug Administration (FDA) approved Duvyzat™ (givinostat), the first nonsteroidal medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients 6 years and older. DMD is the most common form of childhood muscular dystrophy, a group of progressive, degenerative diseases affecting the skeletal muscles. DMD primarily affects males, and symptoms appear during toddler years. DMD is characterized by deterioration of muscle fibers, and patients experience progressive weakness along with reduction in muscle strength and size. Typically, the upper legs and pelvis are affected first, followed by the upper arms. This may affect gait, increase frequency of falls and lead to difficulty ambulating. As the disease progresses, muscles of the diaphragm may be affected, leading to difficulty breathing, swallowing issues and heart problems. Duvyzat™ is an oral medication that targets the degenerative effects of DMD, helping to reduce inflammation and loss of muscle. The change in physical function and the speed of climbing four stairs was compared in those receiving Duvyzat™ with a standard-of-care steroid regimen and those receiving placebo with steroid regimen. Patients receiving Duvyzat™ showed less worsening of physical function and a faster speed of climbing four stairs at 18 months compared to patients receiving placebo. The most common side effects included diarrhea, nausea, vomiting, abdominal pain, elevated triglycerides and decreased number of platelets (increasing bleeding risk). Duvyzat™ was granted priority review, fast track, orphan drug, and rare pediatric disease designations.

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Drug Safety

Voluntary Recall of Vancomycin Hydrochloride for Oral Solution

Amneal Pharmaceuticals announced a voluntary recall of 4 lots of vancomycin hydrochloride oral solution due to the bottles being filled with more powder for reconstitution than is required, and the associated risk of receiving too high of a dose. Vancomycin is an antibiotic that, when administered orally, can be used for the treatment of infections of the colon caused by Staphylococcus aureus or Clostridium difficile. The maximum daily dose of oral vancomycin is 2 grams per day. However, due to the excess powder, some of the recalled bottles may dispense up to 4 grams per day, increasing the risk for side effects such as abdominal pain and low blood potassium levels. To date, there have been no reports of adverse events related to this recall. Amneal is directly contacting customers with a recall notification letter and providing arrangements for the return of affected products. Consumers should examine their bottle and discontinue use of the product if it has a recalled lot number. These include 22613003A, 22613004A, 22613005A and 22613005B, and all have an expiration date of 9/2025. Consumers may call or email Amneal for information and instructions. If any adverse effects are experienced, consumers should contact their health care provider and report it to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

New York Pharmacists Can Now Provide Hormonal Contraception Without a Prescription

On March 19, 2024, Governor Hochul announced a new standing order that allows pharmacists in New York State to dispense three types of self-administered hormonal contraceptives without a prescription. The three types include oral hormonal pills, hormonal vaginal rings and hormonal contraceptive patches. Self-administered hormonal contraceptives may be used for multiple purposes, including pregnancy prevention and management of irregular menstrual cycles. Participating pharmacists can dispense up to 12 months of hormonal contraception based on individuals’ preferences and insurance coverage. The pharmacist is required to provide the individual with a self-screening patient intake form, and the form must be renewed every 12 months. Pharmacists can select the most appropriate medication and provide counseling, including directions for use, potential adverse effects and risk for sexually transmitted infection. Within 72 hours, pharmacists will notify the individual’s primary health care practitioner to inform and coordinate care for patients. Authorizing pharmacists to prescribe hormonal contraceptives is intended to enhance patient convenience and promote better reproductive health outcomes. Individuals should speak with their pharmacist for more information about this service.

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FDA Approvals

New FDA Approvals

New Drug: Vafseo® (vadadustat)

Oral Tablets approved for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. [3/27/2024- AKEBIA THERAPEUTICS]

New Drug: Tryvio™ (aprocitentan) 

Oral Tablets approved for the treatment of high blood pressure, in combination with other antihypertensive medications, in adult patients who have not achieved adequate control on those other medications alone. [3/20/2024- IDORSIA PHARMACEUTICALS]