Classes
DEA Class; Rx
Common Brand Names; Valcyte
- Antivirals, CMV;
- Antivirals, Other
Description
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
Indications
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)
Contraindications
History of clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or excipients
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection.
900 mg/day PO for prophylaxis; 1,800 mg/day PO is used off-label for treatment of CMV infection.
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
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.
Dosage is based on BSA and CrCl; alternatively, 32 mg/kg/day PO has been used off-label for congenital CMV disease.
Safety and efficacy have not been established; however, 32 mg/kg/day PO has been used off-label for congenital CMV disease.
How supplied
Valganciclovir hydrochloride
tablet
- 450mg
powder for oral solution
- 50mg/mL when reconstituted
