Tenofovir Disoproxil Fumarate Teva Use In Pregnancy & Lactation

Pregnancy: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil fumarate. Animal studies do not indicate reproductive toxicity. The use of tenofovir disoproxil fumarate may be considered during pregnancy, if necessary.
In the literature, exposure to tenofovir disoproxil fumarate in the third trimester of pregnancy has been shown to reduce the risk of HBV transmission from mother to infant if tenofovir disoproxil fumarate is given to mothers, in addition to hepatitis B immune globulin and hepatitis B vaccine in infants.
In three controlled clinical trials, a total of 327 pregnant women with chronic HBV infection were administered tenofovir disoproxil fumarate (300 mg) once daily from 28 to 32 weeks gestation through 1 to 2 months postpartum; women and their infants were followed for up to 12 months after delivery. No safety signal has emerged from these data.
Breast-feeding: Tenofovir has been shown to be excreted in human milk. There is insufficient information on the effects of tenofovir in newborns/infants. Therefore Tenofovir Disoproxil Fumarate Teva Tablet should not be used during breast-feeding. As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Fertility: There are limited clinical data with respect to the effect of tenofovir disoproxil fumarate on fertility. Animal studies do not indicate harmful effects of tenofovir disoproxil fumarate on fertility.