Valganciclovir Pregnancy and Breastfeeding Warnings

Valganciclovir is also known as: Valcyte

Valganciclovir Pregnancy Warnings

Valganciclovir has been assigned to pregnancy category C by the FDA. Animal studies revealed evidence of embryolethality, fetotoxicity, and teratogenicity. Ganciclovir, the active metabolite, has been shown to be mutagenic in animal studies. There are no controlled data in human pregnancy. The manufacturer recommends that men use barrier method birth control during and for at least 90 days following valganciclovir therapy. Women should practice effective contraception during and for at least 30 days after valganciclovir therapy. Valganciclovir is only recommended for use during pregnancy when benefit outweighs risk.

Using an ex vivo human placental cotyledon model, ganciclovir has been shown to cross the placenta, achieving fetal concentrations of 17% to 19% of maternal concentrations.

Valganciclovir Breastfeeding Warnings

There are no data on the excretion of valganciclovir into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants (granulocytopenia, anemia, thrombocytopenia, mutagenicity, carcinogenicity), a decision should be made to discontinue the drug, taking into account the importance of the drug to the mother. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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