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Valganciclovir

    Brands

    DEA Class; Rx

    Common Brand Names; Valcyte

    • Antivirals, CMV; 
    • Antivirals, Other

    Oral antiviral agent; prodrug of acyclovir
    Used to treat chickenpox, herpes zoster, herpes labialis (cold sores), and genital herpes
    Formulated to improve oral bioavailability with less frequent dosing than oral acyclovir

    Indicated for treatment of CMV retinitis in patients with AIDS

    Indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])

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

    History of clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or excipients

    • Abdominal pain (15%)
    • Anemia (8-26%)
    • Diarrhea (16-41%)
    • Fever (31%)
    • Granulocytopenia (11-27%)
    • Headache (9-22%)
    • Insomnia (16%)
    • Nausea (8-30%)
    • Retinal detachment (15%)
    • Vomiting (21%)
    • Peripheral neuropathy (9%)
    • Paresthesia (8%)
    • Thrombocytopenia (8%)

    May be teratogenic or embryotoxic, avoid pregnancy; male patients advised to use barrier method during and for 90 days after treatment (see Pregnancy)

    Females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment because of potential risk to fetus; similarly, males should be advised to use condoms during and for at least 90 days following treatment

    Acute renal failure may occur in elderly patients with or without reduced renal function; exercise caution when administering to geriatric patients; dosage reduction is recommended for those with impaired renal function, patients receiving potential nephrotoxic drugs, and patients without adequate hydration

    After oral administration, valganciclovir (prodrug) converts to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity

    No data available regarding presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, effects on breastfed infant or on milk production

    Adults

    900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection.

    Geriatric

    900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection.

    Adolescents

    17 years: 900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection.
    13 to 16 years: Dosage is based on BSA and CrCl; not to exceed 900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection

    Children

    Dosage is based on BSA and CrCl; not to exceed 900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection in children old enough to receive adult dosage.

    Infants

    Dosage is based on BSA and CrCl; alternatively, 32 mg/kg/day PO has been used off-label for congenital CMV disease.

    Neonates

    Safety and efficacy have not been established; however, 32 mg/kg/day PO has been used off-label for congenital CMV disease.

    Valganciclovir hydrochloride

    tablet

    • 450mg

    powder for oral solution

    • 50mg/mL when reconstituted