Descovy Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of Descovy or its components in pregnant women. There are no or limited data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women. However, a large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development. Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see Pharmacology: Toxicology under Actions).
Descovy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding: It is not known whether tenofovir alafenamide is excreted in human milk. Emtricitabine is excreted in human milk. In animal studies it has been shown that tenofovir is excreted in milk.
There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants. Therefore, Descovy should not be used during breast-feeding. In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Fertility: There are no data on fertility from the use of Descovy in humans. In animal studies there were no effects of emtricitabine and tenofovir alafenamide on mating or fertility parameters (see Pharmacology: Toxicology under Actions).