Section 15 · Monograph
Ganciclovir
Reviewed Nov 2026FDA label
CytoveneAntiviral (nucleoside analog)
- Forms
- IV: 500mg vial
- Dose
- CMV encephalitis or ventriculitis: 5mg/kg IV every 12 hours (renal adjustment); often combined with foscarnet
- MOA
- Phosphorylated to ganciclovir triphosphate; inhibits CMV DNA polymerase
Black Box Warning
- Hematologic toxicity (severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia), impairment of fertility, fetal toxicity, mutagenesis and carcinogenesis
Indications
- CMV retinitis treatment and prevention of CMV disease in transplant recipientsFDA-labeled
Off-Label Uses
- CMV encephalitis, ventriculitis and polyradiculitisOff-label
Mechanism of Action
- Nucleoside analog phosphorylated by CMV UL97 kinase to ganciclovir triphosphate, which inhibits viral DNA polymerase
Full Dosing
Adult / usual
- CMV CNS disease: ganciclovir with or without foscarnet per current opportunistic infection guidelines; maintenance 5mg/kg once daily
- Infuse over 1 hour; hydrate
Renal
- Induction: 5mg/kg IV every 12 hours for 14-21 days, adjusted for creatinine clearance
Contraindications
- Hypersensitivity to ganciclovir or valganciclovir
- Absolute neutrophil count under 500/µL, platelets under 25,000/µL, or hemoglobin under 8g/dL
Drug Interactions
- Imipenem-cilastatin: seizure risk
- Mycophenolate, zidovudine and other myelosuppressives: additive hematologic toxicity
- Nephrotoxic drugs reduce clearance
Adverse Effects
- Neutropenia, anemia, thrombocytopenia
- Confusion, seizures and hallucinations
- Renal dysfunction
- Fever, rash, nausea
Monitoring Parameters
- CBC with differential and platelets at least twice weekly during induction
- Serum creatinine
- CMV viral load and clinical response
Pregnancy & Lactation
- Fetal toxicity and teratogenic in animals; avoid in pregnancy unless life-threatening; effective contraception required
- Breastfeeding not recommended