Fetal Risk

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emtricitabine - tenofovir alafenamide (FDA-USA)

There are insufficient human data on the use of Emtricitabine - Tenofovir Alafenamide during pregnancy to inform a drug-associated risk of birth defects and miscarriage. Tenofovir Alafenamide (TAF) use in women during pregnancy has not been evaluated; however, Emtricitabine (FTC) use during pregnancy has been evaluated in a limited number of women reported to the Antiretroviral Pregnancy Registry (APR). Available data from the APR show no difference in the risk of overall major birth defects for FTC (2.4%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The rate of miscarriage is not reported in the APR. In animal studies, no adverse developmental effects were observed when the components of Emtricitabine - Tenofovir Alafenamide were administered separately during the period of organogenesis at exposures 60 and 108 times (mice and rabbits, respectively) the FTC exposure and at exposure equal to or 53 times (rats and rabbits, respectively) the TAF exposure at the recommended daily dose of Emtricitabine - Tenofovir Alafenamide. Likewise, no adverse developmental effects were seen when FTC was administered to mice through lactation at exposures up to approximately 60 times the exposure at the recommended daily dose of Emtricitabine - Tenofovir Alafenamide. No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 14 times the exposure at the recommended daily dosage of Emtricitabine - Tenofovir Alafenamide.