Tafnat Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of 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 1000 exposed outcomes) indicates no malformative nor feto/neonatal toxicity associated with the use of tenofovir disoproxil fumarate.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The use of Tenofovir Alafenamide tablets may be considered during pregnancy, if necessary.
Breast-feeding: It is not known whether tenofovir alafenamide is secreted in human milk. However, in animal studies it has been shown that tenofovir is secreted into milk. There is insufficient information on the effects of tenofovir in newborns/infants.
A risk to the breastfed child cannot be excluded; therefore, Tenofovir Alafenamide tablets should not be used during breast-feeding.
Fertility: No human data on the effect of Tenofovir Alafenamide tablets on fertility are available. Animal studies do not indicate harmful effects of tenofovir alafenamide on fertility.