Valfix Use In Pregnancy & Lactation

Pregnancy: 100 mg: Studies in humans have confirmed that Lamivudine crosses the placenta. Lamivudine concentrations in infant serum at birth were similar to those in maternal and cord serum at delivery.
Use in pregnancy should be considered only if the benefit outweighs the risk. Although the results of animal studies are not always predictive of human response, the findings in the rabbit suggest a potential risk of early embryonic loss.
Consequently, Lamivudine administration is not recommended during the first three months of pregnancy.
For patients who are being treated with Lamivudine and subsequently become pregnant consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of Lamivudine.
150 mg: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Lamivudine can be used during pregnancy if clinically needed. The malformative risk is unlikely in humans.
For patients co-infected with hepatitis who are being treated with lamivudine and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
100 mg: Lactation: Lamivudine should only be used in a nursing mother if the expected benefit justifies the potential risk to the infant. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from Lamivudine therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
150 mg: Breastfeeding: Following oral administration lamivudine was excreted in breast milk at similar concentrations to those found in serum. Serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age. There are no data available on the safety of lamivudine when administered to babies less than three months old. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV. Fertility: Lamivudine had no effect on fertility.