This dosage information may not include all the information needed to use Valganciclovir safely and effectively. See additional information for Valganciclovir.
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for CMV Retinitis
Induction dose: 900 mg orally twice a day for 21 days
Maintenance dose: 900 mg orally once a day
Usual Adult Dose for CMV Prophylaxis
900 mg orally once a day starting within 10 days of transplantation
Heart or kidney-pancreas transplant patients: Therapy should continue until 100 days posttransplantation.
Kidney transplant patients: Therapy should continue until 200 days posttransplantation.
Usual Pediatric Dose for CMV Prophylaxis
Kidney or heart transplant patients:
4 months to 16 years: The recommended once daily oral dose of valganciclovir starting within 10 days of transplantation until 100 days posttransplantation is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the following equation:
Pediatric dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula). If the calculated Schwartz CrCl exceeds 150 mL/min/1.73 m2, then a maximum value of 150 mL/min/1.73 m2 should be used in the equation.
Mosteller BSA (m2) = the square root of (height [cm] x weight [kg] divided by 3600)
Schwartz CrCl (mL/min/1.73 m2) = k x height (cm) divided by serum creatinine (mg/dL)
where k =
4 months to less than 1 year: 0.45
1 to less than 2 years: 0.45 (note: k value is 0.45 instead of the typical value of 0.55)
2 to less than 13 years (boys) and 2 to 16 years (girls): 0.55
13 to 16 years (boys): 0.7
All calculated doses should be rounded to the nearest 25 mg increment for actual deliverable dose, up to maximum dose of 900 mg. Valganciclovir oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above; however, valganciclovir tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg). For example, one 450 mg tablet may be taken for calculated doses between 405 mg and 495 mg.
Renal Dose Adjustments
CrCl 40 to 59 mL/min:
Induction dose: 450 mg orally twice a day for 21 days
Maintenance/prevention dose: 450 mg orally once a day
CrCl 25 to 39 mL/min:
Induction dose: 450 mg orally once a day for 21 days
Maintenance/prevention dose: 450 mg orally every 2 days
CrCl 10 to 24 mL/min:
Induction dose: 450 mg orally every 2 days for 21 days
Maintenance/prevention dose: 450 mg orally twice a week
CrCl less than 10 mL/min (on hemodialysis): Not recommended. A reduced dosage of ganciclovir is recommended for these patients.
Dosing in pediatric patients with renal impairment can be done using the recommended equations because CrCl is a component in the calculation.
Liver Dose Adjustments
Safety and efficacy have not been established in patients with hepatic impairment.
Patients with inactive CMV retinitis do not need to begin therapy with the induction dosage and can be started on the 900 mg once daily dosing.
Clinical toxicity of valganciclovir, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia. Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia, and aplastic anemia have been observed in patients treated with valganciclovir or ganciclovir. Valganciclovir should not be used in patients with absolute neutrophil count less than 500/mm3, platelet count less than 25,000/mm3, or hemoglobin less than 8 g/dL. Valganciclovir should be used with caution in patients with preexisting cytopenias or who have received or who are receiving myelosuppressive drugs or irradiation. Cytopenias may occur any time during therapy and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. Complete blood counts with differential and platelet counts should be performed frequently, especially in patients whose neutrophil counts are less than 1000/mm3 at the start of therapy or who have experienced leukopenia with ganciclovir or other nucleoside analogs. Increased monitoring for cytopenias may be necessary if therapy is changed from oral ganciclovir to valganciclovir due to increased plasma levels of ganciclovir following the use of valganciclovir.
In animal studies, ganciclovir was carcinogenic, teratogenic, mutagenic, and caused aspermatogenesis. Since animal data indicate ganciclovir administration is carcinogenic, valganciclovir should be considered a potential carcinogen in humans, and because animal data indicate ganciclovir is teratogenic and mutagenic, valganciclovir should be considered to have the potential to cause birth defects and cancers in humans. Women of childbearing potential should be advised to use effective contraception during and for at least 30 days after valganciclovir therapy. Also, male patients should be advised to practice barrier contraception during and for at least 90 days after valganciclovir therapy. Valganciclovir at the recommended doses may cause temporary or permanent aspermatogenesis and may suppress fertility in females.
Acute renal failure may occur in elderly patients (with or without renal dysfunction), in patients receiving potentially nephrotoxic drugs, and in patients without adequate hydration. Therefore, elderly patients should be administered valganciclovir with caution (dosage reduction is recommended for those with renal dysfunction), caution is recommended during concomitant administration of valganciclovir with potentially nephrotoxic drugs, and all patients should receive sufficient hydration.
Valganciclovir is not indicated for use in liver transplant patients. Safety and efficacy have not been established for prevention of CMV disease in solid organ transplants other than kidney, heart, and kidney-pancreas. Safety and efficacy have not been established for treatment of congenital CMV disease.
Ganciclovir is not a cure for CMV retinitis and progression of retinitis may occur during or following treatment. Ophthalmologic follow-up examinations are recommended at least every 4 to 6 weeks during valganciclovir therapy; however, some patients may require more frequent follow-up.
Ganciclovir and valganciclovir tablets are not bioequivalent and cannot be substituted on a one-to-one basis.
Safety and efficacy have not been established in pediatric patients less than 4 months of age.
Hemodialysis (CrCl less than 10 mL/min): Not recommended. A reduced dosage of ganciclovir is recommended for these patients.
Valganciclovir should be administered with food.
Adult patients should use valganciclovir tablets, not valganciclovir oral solution.
The oral solution should be stored under refrigeration for no longer than 49 days and should not be frozen.