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Pulse Newsletter

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

Volume 5 | Issue 22
December 15, 2023

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

Clinical Pharmacy Update

FDA Approves First Treatment for Desmoid Tumors

On November 27, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of OgsiveoTM (nirogacestat) for the treatment of progressing desmoid tumors in adult patients who need systemic treatment. Desmoid tumors are noncancerous growths found in the connective tissue of the abdomen, arms and legs. They do not spread to other areas of the body, but they can grow rapidly and impact surrounding tissues and organs. Patients with desmoid tumors may experience pain and mobility issues that impact their quality of life. OgsiveoTM is the first treatment approved for desmoid tumorsand will be available as oral tablets. In a randomized, double-blind, placebo-controlled trial, 142 patients with progressing desmoid tumors were given OgsiveoTM or placebo. Participants in the OgsiveoTM group showed improvement in progression-free survival and a higher objective response rate compared to placebo. Common adverse effects include diarrhea, disrupted menstrual cycle, rash, nausea, fatigue, inflammation of the mouth, headache, abdominal pain, cough, hair loss, upper respiratory tract infection and shortness of breath. OgsiveoTM was granted Priority Review, Breakthrough Therapy designation, Fast Track designation and Orphan Drug designation by the FDA. 

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Drug Safety

Recall of KinderMed Products Due to Acetaminophen Instability

On November 13, 2023, KinderFarms, LLC announced a voluntary recall of KinderMed Infants’ Pain & Fever oral suspension and KinderMed Kids’ Pain & Fever oral suspension due to instability of the main ingredient, acetaminophen. Some product lots were found to be outside of expected standards, and use of the product could cause side effects such as abdominal pain, nausea, vomiting or jaundice at high doses. All lots of the following products are being recalled: KinderMed Infants’ Pain & Fever 2 fluid ounces/59 mL Oral Suspension (UPC: 850001805698) and KinderMed Kids’ Pain & Fever 4 fluid ounces/118 mL Oral Suspension (UPC: 850001805728). These medications were widely distributed via both retail and online companies and any consumers who purchased the products are advised to stop using them and return the products to the place of purchase for a full refund. To date, there have been no reports of adverse events associated with this recall. Patients experiencing any adverse events related to the product are advised to contact their physician or health care provider and to report the event to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Identifying Prediabetes Risk in Americans 

In recognition of World Diabetes Day on November 14, 2023, the Centers for Disease Control and Prevention (CDC) announced a new “Be Your Own Hero” public service announcement (PSA), supporting their “Do I Have Prediabetes?” initiative. This PSA encourages patients to identify their risk of prediabetes so they can make lifestyle changes to delay or prevent progression to type 2 diabetes if they are at high risk. Prediabetes is defined as having blood sugar levels that are higher than normal but not high enough to meet the criteria for diabetes. Even before progression to type 2 diabetes, patients with prediabetes are at an increased risk for heart attack and stroke. It has been shown that a diagnosis of prediabetes inspires patients to make preventative lifestyle changes, such as increasing physical activity or improving diet. The CDC encourages all individuals to complete the prediabetes risk test, which is a short survey that assesses a patient’s age, family medical history, personal medical history, ethnicity, physical activity, gender and BMI. This risk assessment is free and only takes approximately 1 minute to complete, but the results could have long-lasting effects on a patient’s health. Whether a patient is at low or high risk of prediabetes, they receive tips to improve physical and mental well-being. Patients deemed high-risk are encouraged to reach out to their health care provider for blood testing to determine if they have prediabetes.

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FDA Approvals

New FDA Approvals

New Drug: Augtyro™ (repotrectinib) for non-small cell lung cancer

Oral capsule approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer [11/15/2023 – BRISTOL-MYERS SQUIBB]

New Drug: Truqap™ (capivasertib) for metastatic breast cancer

Oral tablets approved to be used in combination with another medication, fulvestrant, in the treatment of adult patients with HR-positive, HER2-negative breast cancer and specific genetic alterations in the tumor [11/16/2023 – ASTRAZENECA]

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New Generics

New Generics Entering the Marketplace

Forteo® (teriparatide)

Indication: Treatment of osteoporosis to increase bone mass in adult patients at high fracture risk.

Dosage Form/Strength: 600mcg/2.4mL subcutaneous injection

Average Wholesale Price (AWP): Generic = $4,748 | Brand = $4,998