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Clinical Highlights: September 2024

Your monthly source for drug information highlights.

September 30, 2024

Shortage Updates

 
  • Eli Lilly’s tirzepatide (Zepbound) is reported as currently available in all strengths, as is the T2DM formulation of tirzepatide (Mounjaro). Additionally, all strengths of Novo Nordisk’s semaglutide (Ozempic) formulation for select patients with T2DM are available, along with all strengths, except for the 0.25 mg strength, of the semaglutide product indicated for weight management (Wegovy). Novo Nordisk’s liraglutide (Saxenda) has limited availability, as does the liraglutide (Victoza) formulation indicated for select patients with T2DM; an authorized generic of Victoza distributed by Teva is available. The GLP-1 receptor agonist dulaglutide (Trulicity), indicated for select patients with T2DM, is available in all strengths

  • .Two of the three strengths of penicillin G benzathine (Bicillin L-A) are available with the remaining strength having an estimated recovery of March 2025. The shortage of this antibiotic is due to increased demand for the drug. The FDA continues to allow temporary importation of benzathine benzylpenicillin (Extencilline) and temporary importation of benzathine benzylpenicillin tetrahydrate (Lentocilin) to mitigate the shortage. Both imported products are available.

  • Shortages of stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) continue to be reported. Availability of generic methylphenidate HCl extended-release (ER) tablets is variable depending on the manufacturer. Brand-name Relexxii from Vertical, as well as brand-name Concerta from Janssen, are currently available. Generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate immediate release (IR) tablet shortages continue to improve, and brand-name Adderall IR tablets from Teva are available. Shortages of the generic version of Vyvanse, lisdexamfetamine dimesylate capsules and chewable tablets persist. Brand-name Vyvanse capsules and chewable tablets remain available from Takeda. To address the lisdexamfetamine shortage, the DEA increased production limits for lisdexamfetamine by nearly 24%.

Drug Information Highlights

 
  • Pfizer has announced the voluntary withdrawal of all lots of the sickle cell disease therapy voxelotor (Oxbryta) and discontinuation of all active clinical trials for the drug. The withdrawal is based on clinical data that suggest an increase in vaso-occlusive crises and fatal events with Oxbryta that necessitate further evaluation.

  • The FDA has issued a Drug Safety Communication warning of rare occurrences of serious liver injury with fezolinetant (Veozah), an oral neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. The new safety concern has been added to the existing warning in the labeling about hepatic transaminase elevation; patients should stop Veozah immediately and contact an HCP if signs or symptoms of liver injury occur. The frequency of hepatic laboratory tests has been increased, and the prescribing information now recommends monthly testing for two months after initiation; testing should also occur at months three, six and nine (already recommended).

  • The CDC has published interim clinical considerations for use of the Smallpox and Monkeypox Vaccine, Live, Nonreplicating (Jynneos) for mpox prevention; Jynneos is FDA-approved for prevention of smallpox and mpox in adults determined to be at high risk for these infections. People at risk of mpox should ideally be vaccinated prior to exposure to mpox virus, but the vaccine can also be used post-exposure to prevent infection. Jynneos has been the predominant vaccine used in the U.S., but Smallpox and Mpox (Vaccinia) Vaccine, Live (ACAM2000) is also indicated for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for these infections; however, this vaccine has more adverse effects and contraindications.

  • The FDA has expanded use of Insulet's SmartAdjust technology utilized by Insulet's Omnipod 5 Automated Insulin Delivery System to include management of T2DM in adults. Previously, the interoperable automated glycemic controller (SmartAdjust Technology) was only indicated for the management of type 1 diabetes mellitus (T1DM) in ages ≥ 2 years old. The SmartAdjust technology software automatically adjusts insulin delivery through a connection to an alternate controller-enabled insulin pump and integrated continuous glucose monitor (iCGM).

  • The FDA's Cardiovascular and Renal Drugs Advisory Committee will convene on Oct. 10, 2024 to discuss the new drug application (NDA) for elamipretide by Stealth Bio. Elamipretide injection is an investigational agent for the treatment of Barth Syndrome, a rare condition characterized by dilated cardiomyopathy, skeletal myopathy, neutropenia and short stature that predominantly affects men.

Drug Information Happenings

 
  • The CDC has published updated recommendations from ACIP in the MMWR on the use of respiratory syncytial virus (RSV) vaccines in adults ≥ 60 years old. In June 2024, ACIP voted in favor of all adults ≥ 75 years of age as well as adults aged 60 to 74 years who are at increased risk for severe RSV disease to receive a single dose of RSV vaccine. 

  • The Institute for Clinical and Economic Review (ICER) has released its final evidence report on imetelstat (Rytelo) for the treatment of anemia in patients with low-to-intermediate risk myelodysplastic syndrome (MDS). A majority of panelists voted that current evidence is inadequate to show a net health benefit for imetelstat plus best supportive care compared to best supportive care alone in patients with lower risk MDS without the del(5q) mutation who are transfusion dependent and ineligible for, or refractory to erythropoiesis-stimulating agents (ESAs). Furthermore, all panelists voted that current evidence is inadequate to show a net health benefit for imetelstat plus best supportive care when compared to luspatercept-aamt (Reblozyl) plus best supportive care in patients with lower risk MDS without the del(5q) mutation who are transfusion dependent and ineligible for, or refractory to ESAs, and are ring sideroblast positive.

  • The U.S. Preventive Services Task Force (USPSTF) has issued final recommendations on screening and supplementation for iron deficiency and iron deficiency anemia during pregnancy. The USPSTF concludes that for asymptomatic pregnant adolescents and adults, evidence is insufficient to recommend for or against screening for iron deficiency and iron deficiency anemia, and evidence is insufficient to determine the benefits versus harms of routine iron supplementation in pregnant patients for prevention of adverse maternal and infant health outcomes.

  • The American College of Gastroenterology (ACG) has published new recommendations for the treatment of Helicobacter pylori (H. pylori) infection in North America. In addition to providing recommendations for treatment-naïve and treatment-experienced patients, the guidelines detail who to test, the need for universal post-treatment test-of-cure, as well as evidence on antibiotic susceptibility testing and its role in determination of initial and salvage treatment.

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care provider.

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