Ganciclovir

CYTOVENE

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Pronunciation: gan-SYE-kloe-veer

Ganciclovir ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Ganciclovir ballicule

What it isViral-kinase-activated guanosine analog inhibiting viral DNA polymerase; cytomegalovirus disease.

Why it mattersThe IV standard for sight- or organ-threatening CMV, where oral prophylactic agents are insufficient.

What it changesMyelosuppression requires frequent counts; renal adjustment, fetal toxicity, fertility impairment, and handling precautions matter.

Ganciclovir molecular structure (skeletal formula) — Molecular structure: Ganciclovir

Ganciclovir prescription history

Animated chart of estimated U.S. prescriptions per year, Antivirals (non-HIV) (1966–2026). Ganciclovir enters in 1994 (estimated).

FDA-approved for

CMV (1989)

Classes and tags

Clinical profile

Therapeutic safety burden4 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Hematologic toxicity (granulocytopenia, anemia, thrombocytopenia, pancytopenia); impairment of fertility; fetal toxicity; mutagenesis and carcinogenesis

FDA dosing	Population	Start	Target	Max
CMV retinitis treatment (immunocompromised incl. AIDS)	Adults, normal renal function	Induction: 5 mg/kg IV over 1 h q12h × 14–21 days	Maintenance: 5 mg/kg IV QD 7 days/wk, or 6 mg/kg QD 5 days/wk	Do not exceed recommended dose/infusion rate
CMV disease prevention (transplant recipients at risk)	Adults, normal renal function	Induction: 5 mg/kg IV over 1 h q12h × 7–14 days	Maintenance: 5 mg/kg IV QD 7 days/wk, or 6 mg/kg QD 5 days/wk, until 100–120 days post-transplant	Do not exceed recommended dose/infusion rate

Renal Induction/maintenance by CrCl (mL/min): ≥70: 5 q12h / 5 q24h; 50–69: 2.5 q12h / 2.5 q24h; 25–49: 2.5 q24h / 1.25 q24h; 10–24: 1.25 q24h / 0.625 q24h; <10 (HD): 1.25 / 0.625 mg/kg 3 times per week after hemodialysis (doses mg/kg)

Hepatic Undefined (not studied)

Not recommended if ANC <500 cells/mcL, Hgb <8 g/dL, or platelets <25000 cells/mcL

Instructions

IV infusion only, over 1 h at constant rate; no rapid/bolus IV, IM or SC
Dilute in typically 100 mL (NS, D5W, Ringer's, LR); infusion conc. not >10 mg/mL
Use within 24 hours of dilution; refrigerate, do not freeze
Ensure adequate hydration
Handle as antineoplastic (pH 11; gloves)
CBC with differential/platelets frequently; monitor renal function; pregnancy test before start

Available strengths

inj 50 mg/mL
gel 0.15 %

Contraindications

Clinically significant hypersensitivity (e.g., anaphylaxis) to ganciclovir or valganciclovir

Cautions

Hematologic toxicity
Renal impairment (serum creatinine increases; reduce dose)
Impairment of fertility
Fetal toxicity (contraception during and 30 days after for females; barrier 90 days for males)
Mutagenesis and carcinogenesis

Adverse reactions

Pyrexia
Diarrhea
Leukopenia
Nausea
Anemia
Asthenia
Headache
Cough
Decreased appetite
Dyspnea
Abdominal pain
Sepsis

Pregnancy Teratogenic/embryolethal in animals at ~2 times RHD; no adequate human data — may cause fetal toxicity

Lactation Breastfeeding not recommended during treatment

Cost

Ganciclovir (CYTOVENE)

Strength		#/mo	generic $/unit	CostPlus
50 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Ganciclovir is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2003

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Self-check

Which blood toxicity requires frequent counts with ganciclovir?
Myelosuppression.
Which viral enzyme class activates ganciclovir?
Viral kinases.