Valcyte Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: In animal studies ganciclovir was found to impair fertility (see Pharmacology: Toxicology: Impairment of Fertility under Actions). In a clinical study, renal transplant patients receiving Valcyte for CMV prophylaxis for up to 200 days were compared to an untreated control group. Spermatogenesis was inhibited during treatment with Valcyte. At follow-up, approximately six months after treatment discontinuation, the mean sperm density in treated patients was comparable to that observed in the untreated control group. In Valcyte treated patients, all patients with normal sperm density (n=7) and 8/13 patients with low sperm density at baseline had normal density after treatment cessation. In the control group, all patients with normal sperm density (n=6) and 2/4 patients with low sperm density at baseline had normal density at the end of follow-up.
Contraception: Women of reproductive potential should be advised to use effective contraception during and for at least 30 days after treatment. Sexually active men are recommended to use condoms during and for at least 90 days after cessation of treatment with Valcyte, unless it is certain that the female partner is not at risk of becoming pregnant (see Precautions and Pharmacology: Toxicology: Reproductive Toxicity under Actions).
Pregnancy: The safety of Valcyte for use in pregnant women has not been established. However, ganciclovir readily diffuses across the human placenta. The use of Valcyte should be avoided in pregnant women unless the benefit to the mother outweighs the potential risk to the fetus.
Reprotoxicity studies have not been repeated with valganciclovir because of the rapid and extensive conversion to ganciclovir. In animal studies ganciclovir was associated with reproductive toxicity and teratogenicity (see Pharmacology: Toxicology: Reproductive Toxicity under Actions).
The safe use of Valcyte during labor and delivery has not been established.
Lactation: Peri- and postnatal development has not been studied with valganciclovir or with ganciclovir but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the nursing infant cannot be discounted. Human data are not available but animal data indicates that ganciclovir is excreted in the milk of lactating rats.
Therefore, a decision should be made to discontinue the drug or discontinue nursing taking into consideration the potential benefit of Valcyte to the nursing mother.