Pregnancy: There are no or limited amount of data from the use of sofosbuvir, velpatasvir or Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg in pregnant women.
Sofosbuvir: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
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.
Velpatasvir: Animal studies have shown a possible link to reproductive toxicity.
As a precautionary measure, Sofosbuvir and Velpatasvir tablet 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, Sofosbuvir and Velpatasvir tablet should not be used during breast-feeding.
Fertility: No human data on the effect of Sofosbuvir and Velpatasvir tablet on fertility are available. Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility.
If ribavirin is co-administered with Sofosbuvir and Velpatasvir tablet, refer to the Summary of Product Characterisitics for ribavirin for detailed recommendations regarding pregnancy, contraception, and breast-feeding.