Valganciclovir

The Basics

What is Valganciclovir?

Used to treat symptoms of cytomegalovirus (CMV) retinitis.

Brand names for Valganciclovir

Valcyte

How Valganciclovir is classified

Anti-Infective Agents, Antiviral Agents

Valganciclovir During Pregnancy

Valganciclovir pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Valganciclovir while pregnant

After oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, VALCYTE is expected to have reproductive toxicity effects similar to ganciclovir. In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two-times the human exposure. There are no available human data on use of VALCYTE or ganciclovir in pregnant women to establish the presence or absence of drug-associated risk. The background risk of major birth defects and miscarriage for the indicated populations is unknown. However, the background risk in the U.S. general population of major birth defects is 2–4% and the risk of miscarriage is 15–20% of clinically recognized pregnancies. Advise pregnant women of the potential risk to the fetus [see WARNINGS AND PRECAUTIONS, Females And Males Of Reproductive Potential]. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome. However, in immunocompromised patients (i.e., transplant patients or patients with AIDS) CMV infections may be symptomatic and may result in significant maternal morbidity and mortality. The transmission of CMV to the fetus is a result of maternal viremia and transplacental infection. Perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract. Approximately 10% of children with congenital CMV infection are symptomatic at birth. Mortality in these infants is about 10% and approximately 50–90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems. The risk of congenital CMV infection resulting from primary maternal CMV infection may be higher and of greater severity than that resulting from maternal reactivation of CMV infection.

Taking Valganciclovir While Breastfeeding

What are recommendations for lactation if you're taking Valganciclovir?

Valganciclovir is rapidly converted to ganciclovir. Several factors might affect the decision to use valganciclovir in a nursing mother. No information is available on the clinical use of ganciclovir or valganciclovir during breastfeeding. Cytomegalovirus (CMV) can be transmitted to infants though breastmilk, with preterm and immunocompromised infants at greatest risk. No information is available on any changes in the risk of transmission if the mother is being treated with ganciclovir or valganciclovir. Although the manufacturer recommends avoiding breastfeeding during valganciclovir use because of the risk of infant drug toxicity, neonates with CMV infections are often treated directly with ganciclovir or valganciclovir. If the mother has a concurrent infection with HIV, breastfeeding is not recommended in the United States and other developed countries.

Maternal / infant drug levels

Valganciclovir is rapidly converted to ganciclovir. Several factors might affect the decision to use valganciclovir in a nursing mother. No information is available on the clinical use of ganciclovir or valganciclovir during breastfeeding. Cytomegalovirus (CMV) can be transmitted to infants though breastmilk, with preterm and immunocompromised infants at greatest risk. No information is available on any changes in the risk of transmission if the mother is being treated with ganciclovir or valganciclovir. Although the manufacturer recommends avoiding breastfeeding during valganciclovir use because of the risk of infant drug toxicity, neonates with CMV infections are often treated directly with ganciclovir or valganciclovir. If the mother has a concurrent infection with HIV, breastfeeding is not recommended in the United States and other developed countries.

Possible effects of Valganciclovir on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Valganciclovir

Letermovir.