Epclusa Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women.
Sofosbuvir: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
It has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Velpatasvir: Animal studies have shown a possible link to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, Epclusa use is not recommended during pregnancy.
Breast-feeding: It is unknown whether sofosbuvir, metabolites of sofosbuvir or velpatasvir are excreted in human milk.
Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk.
A risk to the newborns/infants cannot be excluded. Therefore, Epclusa should not be used during breast-feeding.
Fertility: No human data on the effect of Epclusa on fertility are available. Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility.
If ribavirin is co-administered with Epclusa, refer to the Summary of Product Characteristics for ribavirin for detailed recommendations regarding pregnancy, contraception, and breast-feeding.