Valganciclovir

What it is and how it works

Valganciclovir is an antiviral drug with activity against CMV [ see Microbiology ].

Indications

Valganciclovir Tablets, USP are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk. Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis : Valganciclovir Tablets, USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [ see Clinical Studies ]. Prevention of CMV Disease : Valganciclovir Tablets, USP are 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-]) [ see Clinical Studies ].

Dosage and administration (summary)

Adult Dosage Treatment of CMV retinitis Induction: 900 mg (two 450 mg tablets) twice a day for 21 days Maintenance: 900 mg (two 450 mg tablets) once a day Prevention of CMV disease in heart or kidney-pancreas transplant patients 900 mg (two 450 mg tablets) once a day within 10 days of transplantation until 100 days post-transplantation Prevention of CMV disease in kidney transplant patients 900 mg (two 450 mg tablets) once a day within 10 days of transplantation until 200 days post-transplantation Pediatric Dosage Prevention of CMV disease in kidney transplant patients 4 months to 16 years of age Dose once a day within 10 days of transplantation until 200 days post-transplantation according …

Contraindications

Valganciclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation . Hypersensitivity to valganciclovir or ganciclovir.

Warnings and precautions

Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function. (2.5, 5.2, 8.5, 8.6) Hematologic Toxicity Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir or ganciclovir.

Pregnancy

Risk Summary After oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity effects similar to ganciclovir.

Storage and supply

Valganciclovir Tablets, USP: Supplied as 450 mg, pink, convex oval tablets with "E114" on one side and plain on the other side. Each film-coated tablet contains 450 mg of valganciclovir as valganciclovir hydrochloride. Valganciclovir Tablets, USP, is supplied in bottles of 60 tablets (NDC 42291-973-60). Store at 25°C (77°F).

Source: Valganciclovir Hydrochloride (Valganciclovir) — US FDA prescribing information, 2026-01-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.