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Pregnancy: There are no data from the use of Valganciclovir in pregnant women. Its active metabolite, ganciclovir, readily diffuses across the human placenta. Based on its pharmacological mechanism of action and reproductive toxicity observed in animal studies with ganciclovir there is a theoretical risk of teratogenicity in humans.
Valganciclovir should not be used in pregnancy unless the therapeutic benefit for the mother outweighs the potential risk of teratogenic damage to the child.
Breast-feeding: It is unknown if ganciclovir is excreted in breast milk, but the possibility of ganciclovir being excreted in the breast milk and causing serious adverse reactions in the nursing infant cannot be discounted.
Therefore, breast-feeding must be discontinued.
Fertility: Women of child-bearing potential must be advised to use effective contraception during treatment and at least 30 days after treatment. Male patients must be advised to practice barrier contraception during, and for at least 90 days following treatment with Valganciclovir unless it is certain that the female partner is not at risk of pregnancy.
