The FDA has approved a lower-dose epinephrine auto-injector (Auvi-Q 0.1 mg – Kaléo) for emergency treatment of anaphylaxis in children weighing 7.5-15 kg (16.5-33 lbs). It is the first epinephrine auto-injector to be approved for use in infants and toddlers weighing less than 15 kg. Previously, Auvi-Q and other epinephrine auto-injectors were only available in 0.15- and 0.3-mg strengths for patients weighing 15-30 kg or ≥30 kg, respectively.The recommended dose of epinephrine for intramuscular (IM) or subcutaneous (SC) administration is 0.01 mg/kg. None of the previously available...

Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2 infection ("long COVID").

Oral antipsychotic drugs used for treatment of schizophrenia, schizoaffective disorder, delusional disorder, and other manifestations of psychosis or mania are listed in Table 1. Parenteral antipsychotic drugs used for treatment of these disorders are listed in Table 2.

The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq – Abbvie) have been approved by the FDA for treatment of moderate to severe atopic dermatitis.

Bevacizumab (Avastin - Genentech) is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor and prevents it from binding to receptors on endothelial cells, inhibiting formation of new blood vessels. Previously approved by the FDA for use in combination regimens for first-line treatment of metastatic colon cancer and metastatic non-small cell lung cancer, and used off-label for treatment of agerelated macular degeneration, it has now also been approved by the FDA for use in combination with paclitaxel (Taxol, and others) for first-line treatment of...

A Medical Letter reader recently received a diagnosis of athlete’s foot and a prescription for Naftin gel, for which his pharmacy charged $145, and his insurance company required a $70 copay because this formulation was not included in its formulary. Do patients need to pay prices like these to treat tinea pedis?

The FDA has approved Triumeq (Viiv Healthcare), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir and the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine, for once-daily treatment of HIV-1 infection. Dolutegravir (Tivicay) was approved as a single agent in 2013.

The FDA has approved extended-release (ER) calcifediol (25-hydroxyvitamin D3; Rayaldee – Opko), a prohormone of calcitriol, the active form of vitamin D3. It is indicated for treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels <30 ng/mL.

Brolucizumab-dbll (Beovu — Novartis), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA as an intravitreal injection for treatment of neovascular (wet) age-related macular degeneration (AMD). It is the fourth VEGF inhibitor to be approved in the US for this indication; bevacizumab (Avastin, and others), a VEGF inhibitor FDA-approved for treatment of breast cancer and other malignancies, has been used off-label for this indication for years.

Two FDA advisory committees recently concluded that use of a nasal spray formulation of the peptide hormone salmon calcitonin for treatment of postmenopausal osteoporosis is associated with an increased risk of cancer. Salmon calcitonin is available as 2 nasal sprays (Miacalcin, Fortical) and an injectable formulation (Miacalcin Injection) for use in osteoporosis.1The new cancer concern arose from the results of an unpublished meta-analysis that included 18 studies of Miacalcin Nasal Spray in which the risk of any cancer was 1.54 times greater (95% CI: 1.06, 2.23) in patients who used the drug...