Thanks for the query.
EVIPLERA (300 mg tenofovir disoproxil fumarate/200 mg Emtricitabine/25 mg Rrilpivirine) tablets. No reproductive toxicity studies have been conducted with Tenofovir DF, Emtricitabine and Rilpivirine in combination.
Tenofovir disoproxil fumarate: Male and female rat fertility and mating performance or early embryonic development were unaffected by an oral Tenofovir DF dose (600 mg/kg/day) that achieved systemic drug exposures that were in excess of the expected value in humans receiving the therapeutic dose (5-fold based on plasma AUC). There was, however, an alteration of the oestrous cycle in female rats.
Emtricitabine: Emtricitabine did not affect fertility in male rats or in female and male mice at respective approximate exposures (AUC) of 130 and 50 to 80 times the exposure in humans. The fertility of offspring was unaffected by treatment of mice from early gestation to the end of lactation (50 times the human exposure).
Rilpivirine: In a study conducted in rats, there were no effects on mating or fertility with rilpivirine up to 400 mg/kg/day, a dose of Rilpivirine that showed maternal toxicity. This dose is associated with an exposure that is approximately 40 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Use in Pregnancy
Pregnancy Category B3
There are no well-controlled clinical studies of EVIPLERA in pregnant women. No embryo- foetal development studies have been conducted with tenofovir DF, emtricitabine and rilpivirine in combination. Because animal reproductive studies are not always predictive of human response, EVIPLERA should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
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