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Ganciclovir

    Brands

    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)

    Indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adults, including patients with acquired immunodeficiency syndrome (AIDS)

    Indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease

    Indicated for treatment of acute herpetic keratitis (dendritic ulcers)

    Also Indicated for

    • CMV Prevention in HIV Infected (Off-label)
    • CMV Colitis or Esophagitis in HIV-Infected Patients (Off-label)

    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

    Adults

    10 mg/kg/day IV; 5 drops/day ophthalmic gel in each affected eye.

    Geriatric

    10 mg/kg/day IV; 5 drops/day ophthalmic gel in each affected eye.

    Adolescents

    Safety and efficacy have not been established for IV dosing; however, 10 mg/kg/day IV has been used off-label for the treatment of CMV infection. 5 drops/day ophthalmic gel in each affected eye.

    Children

    2 to 12 years: Safety and efficacy have not been established for IV dosing; however, doses up to 15 mg/kg/day IV have been used off-label for the treatment of CMV infection. 5 drops/day ophthalmic gel in each affected eye.
    1 year: Safety and efficacy have not been established; however, doses up to 15 mg/kg/day IV have been used off-label for the treatment of CMV infection.

    Infants

    Safety and efficacy have not been established; however, doses up to 15 mg/kg/day IV have been used off-label for the treatment of CMV infection.

    Neonates

    Safety and efficacy have not been established; however, doses of 12 mg/kg/day IV have been used off-label for the treatment of congenital CMV disease.

    Ganciclovir sodium

    injection, lyophilized powder for reconstitution

    • 500mg

    ophthalmic gel

    • 0.15% (5g)