Ganciclovir

DEA Class; Rx

Common Brand Names; Cytovene, Vitrasert DSC, Zirgan

• Antivirals, CMV; 
• Ophthalmic

Synthetic purine nucleoside analog antiviral
Used for prevention and treatment of CMV; ophthalmic gel approved for acute herpetic keratitis
Dose adjustment may be required for hematological toxicity (neutropenia, thrombocytopenia)

Hypersensitivity reaction (eg, anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation

• Neutropenia w/ ANC <1000/cu.mm (25-50%)
• Thrombocytopenia (20%)
• Elevated LFTs
• Anemia
• Confusion
• Visual acuity loss (10-20%)
• Retinal detachment (10-20%)
• Vitreous hemorrhage (10-20%)
• Headache
• Nausea/vomiting
• Neuropathy
• Paresthesia
• Pruritus
• Retinal detachment,
• Rash
• Sepsis
• Weakness

Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia observed; not recommended if the absolute neutrophil count (ANC) <500 cells/mcL, hemoglobin <8 g/dL, or the platelet count <25,000 cells/mcL

Exercise caution patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation; granulocytopenia (neutropenia) usually occurs during first or second week of treatment but may occur at any time during treatment; cell counts usually begin to recover within 3-7 days after discontinuing drug Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving IV solution for treatment of CMV retinitis

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

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

No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production