View the Expanded Table: Some Oral Drugs for Chronic Insomnia

Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not comment on the safety or effectiveness of their products beyond the date on the label. Since our last article on this subject, more data have become available.

The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases. The drug received accelerated approval for the same indication in 2020 based on initial overall response rates and duration of response.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer in patients who received prior therapy. Biliary tract cancer includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma. Zanidatamab is the first dual HER2-targeted therapy to be approved in the US for this indication. Accelerated approval was based on the overall response rate and duration of response.

The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.

View the COVID-19 Vaccine Comparison Chart

The FDA has approved an intranasal formulation of the opioid antagonist nalmefene (Opvee – Indivior) for emergency treatment of known or suspected opioid overdose in persons ≥12 years old. Nalmefene, which is available by prescription, is the second opioid antagonist to become available as a nasal spray for this indication; the first was naloxone, which is now available for sale over the counter (Narcan, and generic). Other nasal spray formulations of naloxone and injectable formulations of nalmefene and naloxone are available by prescription (see Table 2).

The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

The Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) recommend using insect repellents to prevent infections transmitted by mosquitoes and ticks. Insect repellents applied to exposed skin should be used in conjunction with other preventive measures such as wearing pants and long-sleeved shirts and avoiding outdoor activities during peak mosquito-biting times. Mosquitoes can transmit diseasecausing pathogens, including Zika, chikungunya, dengue, West Nile, eastern equine encephalitis, and yellow fever viruses, and the malaria parasite....