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 mattersIt is the 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

FDA-approved for

CMV (1989)

FDA label

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BOXED WARNING Hematologic toxicity (granulocytopenia, anemia, thrombocytopenia); carcinogenic, teratogenic, aspermatogenic in animals; capsules carry risk of more rapid CMV retinitis progression — maintenance use only when benefit outweighs risk

FDA dosing	Population	Start	Target
CMV retinitis maintenance (immunocompromised)	Normal renal function	1000 mg TID	1000 mg TID or 500 mg every 3 h (6x/day, waking hours)
CMV disease prevention (advanced HIV)	Adults	1000 mg TID	1000 mg TID
CMV disease prevention (transplant recipients)	Adults	1000 mg TID	1000 mg TID

Renal Reduce dose per creatinine clearance (e.g., CrCl ≥70: 1000 mg TID or 500 mg q3h); lower for reduced CrCl

Hepatic Undefined

Recommended dose should not be exceeded

Instructions

Take with food
Capsules must not be used for induction treatment

Available strengths

inj 50 mg/mL
gel 0.15 %

Contraindications

Hypersensitivity to ganciclovir or acyclovir

Cautions

Granulocytopenia, anemia, thrombocytopenia
Risk of more rapid CMV retinitis progression with oral capsules vs IV
Potential carcinogenicity/teratogenicity/impaired spermatogenesis

Adverse reactions

Neutropenia
Anemia
Thrombocytopenia
GI intolerance

Pregnancy Category C; embryotoxic and teratogenic in animals; use only if benefit justifies fetal risk

Lactation Undefined

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

⚠ BOXED WARNINGS

Hematologic toxicity
Impairment of fertility
Fetal toxicity
Mutagenesis and carcinogenesis

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.

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