Valganciclovir — Membership Pricing

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What Valganciclovir is approved for (FDA label)

Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients (1.1) 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.

Source: Read the full FDA label on DailyMed. Label effective date: June 24, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Valganciclovir (FDA label)

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir [see Warnings and Precautions (5.1) ]. Impairment of Fertility: Based on animal data, and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions (5.3) ]. Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ]. Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans [see Warnings and Precautions (5.5) ]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning . Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir (5.1) . Impairment of Fertility: Based on animal data, and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. (5.3) Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans. (5.4) Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans. (5.5)

Source: FDA prescribing information (DailyMed). Set ID: 4db6dd63-e56b-45a4-86b2-ee125a1854a0. SPL document ID: 55015e34-52fc-0309-e063-6394a90af0f9. Label effective date: June 24, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Valganciclovir (FDA label)

Valganciclovir Tablets, USP 450 mg are pink colored, oval shaped, film coated tablets debossed with ‘RDY’ on one side and ‘762’ on other side. Tablets: 450 mg (3)

Source: FDA prescribing information (DailyMed). Set ID: 4db6dd63-e56b-45a4-86b2-ee125a1854a0. SPL document ID: 55015e34-52fc-0309-e063-6394a90af0f9. Label effective date: June 24, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Valganciclovir (FDA label)

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions (5.1) ]. Acute Renal Failure [see Warnings and Precautions (5.2) ]. Impairment of Fertility [see Warnings and Precautions (5.3) ]. Fetal Toxicity [see Warnings and Precautions (5.4) ]. Mutagenesis and Carcinogenesis [see Warnings and Precautions (5.5) ]. The most common adverse reactions and laboratory abnormalities reported in at least one indication by greater than or equal to 20% of adult patients treated with valganciclovir tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting.

Source: FDA prescribing information (DailyMed). Set ID: 4db6dd63-e56b-45a4-86b2-ee125a1854a0. SPL document ID: 55015e34-52fc-0309-e063-6394a90af0f9. Label effective date: June 24, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Valganciclovir (FDA label)

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 [see Adverse Reactions (6.1) ]. Hypersensitivity to valganciclovir or ganciclovir (4)

Source: FDA prescribing information (DailyMed). Set ID: 4db6dd63-e56b-45a4-86b2-ee125a1854a0. SPL document ID: 55015e34-52fc-0309-e063-6394a90af0f9. Label effective date: June 24, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Valganciclovir (FDA label)

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) . 5.1 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. Valganciclovir should be avoided if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dL. Valganciclovir should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing.

Source: FDA prescribing information (DailyMed). Set ID: 4db6dd63-e56b-45a4-86b2-ee125a1854a0. SPL document ID: 55015e34-52fc-0309-e063-6394a90af0f9. Label effective date: June 24, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Valganciclovir (FDA label)

In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for valganciclovir. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of valganciclovir and other renally excreted drugs, patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug. Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 9 . Table 9 Established and Other Potentially Significant Drug Interactions with Ganciclovir Name of the Concomitant Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment Imipenem-cilastatin Unknown Coadministration with imipenem-cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin.

Source: FDA prescribing information (DailyMed). Set ID: 4db6dd63-e56b-45a4-86b2-ee125a1854a0. SPL document ID: 55015e34-52fc-0309-e063-6394a90af0f9. Label effective date: June 24, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.