Ganciclovir

Ganciclovir is a prescription medication used to treat Cytomegalovirus (CMV) Retinitis, and prevent CMV in Transplant Recipients. 

• Ganciclovir is available under the following different brand names: Antivirals, CMV

Adult dosage

• Injection, lyophilized powder for reconstitution
• 500mg

CMV Retinitis

Adult dosage

• Induction: 5 mg/kg IV every 12 hours, infused over 1 hour for 14-21 days
• Maintenance: 
  • following induction treatment, 5 mg/kg IV once daily, or
  • 6 mg/kg IV once daily for 5 days/week

CMV Prevention in Transplant Recipients

Adult dosage

• Induction: 5 mg/kg IV once daily infused over 1 hour for 7-14 days
• Maintenance:
  • 5 mg/kg IV once daily 100-120 days after transplant, or
  • 6 mg/kg IV once daily for 5 days/week for 100-120 days after transplant 

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Ganciclovir include:

• nausea, 
• diarrhea, 
• stomach pain, 
• loss of appetite, 
• fever, 
• weakness, 
• low blood cell counts,
• headache,
• cough, 
• trouble breathing, and
• increased sweating

Serious side effects of Ganciclovir include:

• hives, 
• difficult breathing, 
• swelling of the face, lips, tongue, or throat, 
• fever, 
• chills, 
• tiredness, 
• mouth sores, 
• skin sores, 
• easy bruising, 
• unusual bleeding, 
• pale skin, 
• cold hands and feet, 
• lightheadedness, 
• shortness of breath, 
• seizure, 
• little or no urination, 
• swelling in the feet or ankles, and
• tiredness

Rare side effects of Ganciclovir include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Ganciclovir has severe interactions with no other drugs. 
• Ganciclovir has serious interactions with the following drugs:
  • abacavir
  • bacitracin
  • imipenem/cilastatin
  • imipenem/cilastatin/relebactam
  • pretomanid
  • ropeginterferon alfa 2b
  • talimogene laherparevpec
  • trilaciclib
  • zidovudine
• Ganciclovir has moderate interactions with at least 18 other drugs.
• Ganciclovir has minor interactions with at least 63 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ganciclovir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ganciclovir?”

Cautions

• Also see Black Box Warnings
• Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia observed; not recommended if the absolute neutrophil count (ANC) less than 500 cells/mcL, hemoglobin less than 8 g/dL, or the platelet count less than 25,000 cells/mcL
• Exercise caution patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation
• Renal impairment should be used with caution in patients with impaired renal function because the half-life and plasma/serum concentrations of ganciclovir will be increased due to reduced renal clearance; increased serum creatinine levels have been reported in elderly patients and in transplant recipients receiving concomitant nephrotoxic medications (eg, cyclosporine and amphotericin B); monitor renal function during therapy is essential, especially for elderly patients and those patients receiving concomitant agents that may cause nephrotoxicity
• Based on animal data and limited human data, recommended human dose (RHD) may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females (see Pregnancy)
• Fetal toxicity may occur when administered to pregnant women based on findings in animal studies (see Pregnancy)
• Animal data indicate that ganciclovir is mutagenic and carcinogenic, may potentially be carcinogenic in humans
• Drug interactions overview
  • Coadministration with imipenem-cilastatin is not recommended because generalized seizures reported
  • Monitor renal function when coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine
  • Based on increased risk, monitor for hematological and renal toxicity when concomitantly using mycophenolate mofetil with ganciclovir
  • Other drugs associated with myelosuppression or nephrotoxicity: Consider only if the potential benefits outweigh the risks
  • Coadministration with didanosine will potentially increase plasma levels and toxicities of didanosine; closely monitor
  • Concomitant use with probenecid may increase ganciclovir levels; consider reducing dose of ganciclovir and monitor possible toxicities

Pregnancy and Lactation

• Placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least 1 case report in a pregnant woman; however, no adequate human data are available to establish whether ganciclovir poses a risk to pregnancy outcomes
• 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 2 times the exposure at the recommended human dose (RHD)
• 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, CMV infections may be symptomatic and may result in significant maternal morbidity and mortality
  • CMV fetal transmission results from maternal viremia and transplacental infection
  • Perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract ~10% of children with congenital CMV infection are symptomatic at birth
  • Mortality in symptomatic infants is ~10% and ~50-90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems
  • 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
• Contraception
  • Test for pregnancy in females of reproductive potential before initiating treatment
  • Females: Because of ganciclovir’s mutagenic and teratogenic potential, use effective contraception during treatment and for at least 30 days following treatment
  • Males: Because of ganciclovir’s mutagenic and teratogenic potential, use barrier contraception during treatment and for at least 90 days following treatment
• Infertility
  • Based on animal data and limited human data, may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females at recommended human dose (RHD); advise patients that fertility may be impaired with use
• Lactation
  • No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production
  • Ganciclovir was present in milk in lactating rats following administration
  • Breastfeeding is not recommended during treatment owing to the potential for serious adverse reactions in nursing infants.