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July 10, 2019

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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.

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