FDA Issues Biktarvy Label Changes
The U.S. Food & Drug Administration has approved changes to the label for the HIV medication Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) that include:
- Expanding the patient population to include pediatric patients with HIV weighing at least 25 kg;
- An update to the Warnings and Precautions Immune Reconstitution Syndrome subsection with autoimmune hepatitis information;
- An update the Drug Interactions Table 3, information pertaining to the coadministration of Biktarvy with polyvalent cation (PVC) containing-antacids and supplements;
- An update to the Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility subsection, with the carcinogenicity data from a 2-year rate study.
The updated label is here.