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Ganciclovir

CYTOVENE

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.

FDA-approved for

FDA label

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 dosingPopulationStartTargetMax
CMV retinitis maintenance (immunocompromised)Normal renal function1000 mg TID1000 mg TID or 500 mg every 3 h (6x/day, waking hours)
CMV disease prevention (advanced HIV)Adults1000 mg TID1000 mg TID
CMV disease prevention (transplant recipients)Adults1000 mg TID1000 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

Contraindications

Cautions

Adverse reactions

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

Lactation Undefined

⚠ BOXED WARNINGS

Cost, est. cash$10–$500/month

Generic entry2003

Classes and tags

Clinical profile

Therapeutic safety burden2 / 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.

Mechanism of action: Ganciclovir ballicule

Ganciclovir ballicule: receptor binding, kinetics and half-life diagram

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