Ganciclovir

The Basics

What is Ganciclovir?

Ganciclovir is indicated for: Sight-threatening CMV retinitis; CMV pneumonitis in bone marrow transplant recipients; Prevention of CMV disease in bone marrow and solid organ transplant recipients; Confirmed CMV retinitis in people with AIDS (intravitreal implant) It is also used for acute CMV colitis. Ganciclovir has also been used with some success in treating Human herpesvirus 6 infections.

Brand names for Ganciclovir

Cytovene

How Ganciclovir is classified

Anti-Infective Agents, Antiviral Agents

Ganciclovir During Pregnancy

Ganciclovir pregnancy category

Category N/ANote 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 Ganciclovir while pregnant

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 exposure at the recommended human dose (RHD) . Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least one case report in a pregnant woman, no adequate human data are available to establish whether CYTOVENE-IV poses a risk to pregnancy outcomes. The background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Taking Ganciclovir While Breastfeeding

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

Several factors might affect the decision to use ganciclovir in a nursing mother. No information is available on the clinical use of ganciclovir 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. Although the manufacturer recommends avoiding breastfeeding during ganciclovir use because of the risk of infant drug toxicity, neonates with CMV infections are often treated directly with ganciclovir. 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

Several factors might affect the decision to use ganciclovir in a nursing mother. No information is available on the clinical use of ganciclovir 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. Although the manufacturer recommends avoiding breastfeeding during ganciclovir use because of the risk of infant drug toxicity, neonates with CMV infections are often treated directly with ganciclovir. If the mother has a concurrent infection with HIV, breastfeeding is not recommended in the United States and other developed countries.

Possible effects of Ganciclovir on milk supply

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

Possible alternatives to Ganciclovir

Letermovir.