Ganciclovir Pregnancy and Breastfeeding Warnings

Ganciclovir is also known as: Cytovene

Ganciclovir Pregnancy Warnings

Ganciclovir has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality, fetotoxicity, teratogenicity, and mutagenicity. There are no controlled data in human pregnancy. Congenital anomalies have been reported during postmarketing experience; however, causality was not definitely determined. Ganciclovir should only be given during pregnancy when benefit outweighs risk. The manufacturer recommends that men use barrier method birth control during and for at least 90 days following ganciclovir therapy. Women of childbearing potential should use effective contraception during ganciclovir therapy.

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. Decreased fertility has been reported in male and female animals and aspermatogenesis/hypospermatogenesis have been reported in male animals.

Ganciclovir Breastfeeding Warnings

There are no data on the excretion of ganciclovir into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, nursing should be discontinued during ganciclovir therapy. The minimum interval before nursing can safely be resumed after the last dose is unknown. In addition, HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

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