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VALCYTE is a brand name for Valganciclovir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VALCYTE (valganciclovir hydrochloride, film coated tablets and powder for oral solution) is indicated for adult patients for: The treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). The prevention of cytomegalovirus (CMV) disease in solid organ transplant…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Caution ‐ Strict adherence to dosage recommendations is essential to avoid overdose. 3 Pharmacokinetics , Absorption). After oral administration, valganciclovir is rapidly and extensively converted into the active ingredient ganciclovir.
The bioavailability of ganciclovir from VALCYTE is significantly higher than from oral ganciclovir. The dosage and administration of VALCYTE tablets or oral solution as described below should be closely followed (see 7 WARNINGS AND PRECAUTIONS , General and
). In animal and in vitro studies, ganciclovir was mutagenic, teratogenic, carcinogenic and caused aspermia; therefore it should be considered a potential teratogen and carcinogen in humans (see 16 NON‐CLINICAL TOXICOLOGY ). VALCYTE is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks stated herein.
The safety and efficacy of VALCYTE have not been evaluated for congenital or neonatal CMV disease, nor for treatment of CMV infection in non‐immunocompromised individuals (see 1 INDICATIONS ). 1 Dosing Considerations Caution ‐ Strict adherence to dosage recommendations is essential to avoid overdose.
3 Pharmacokinetics , Absorption). After oral administration, valganciclovir is rapidly and extensively converted into the active ingredient ganciclovir. The bioavailability of ganciclovir from VALCYTE is significantly higher than from oral ganciclovir.
The dosage and administration of VALCYTE tablets or oral solution as described below should be closely followed (see 7 WARNINGS AND PRECAUTIONS , General and 5 OVERDOSAGE ). 3 Pharmacokinetics , Special Populations and Conditions, Hemodialysis).
3 Comparative Bioavailability Studies ). Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression and aplastic anemia have been observed in patients treated with VALCYTE tablets (and ganciclovir).
Therapy should not be initiated if the absolute neutrophil count is less than 500 cells/μL, or the hemoglobin is less than 80 g/L, or the platelet count is less than 25,000/μL (see 7 WARNINGS AND PRECAUTIONS , Hematologic and Monitoring and Laboratory Tests, and 8 ADVERSE REACTIONS).
Due to the frequency of leukopenia, granulocytopenia (neutropenia), anemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anemia in patients taking VALCYTE, it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/μL at the beginning of treatment.
and 14 CLINICAL TRIALS for information on specific solid organ transplant subgroups)). 3 Pediatrics ). 2 Geriatrics Geriatrics (> 65 years of age): The pharmacokinetic profiles of VALCYTE in elderly patients have not been established.
4 Geriatrics ). 2 CONTRAINDICATIONS VALCYTE (valganciclovir hydrochloride) is contraindicated in patients who are hypersensitive to valganciclovir, ganciclovir or to any ingredient in the formulation, including any non‐medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING . Due to the similarity of the chemical structure of valganciclovir and that of acyclovir and its pro‐ drug valacyclovir, a cross‐hypersensitivity reaction between these drugs is possible.
VALCYTE® (valganciclovir hydrochloride) Page 5 of 56 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions The clinical toxicity of VALCYTE (valganciclovir hydrochloride) includes: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure, and aplastic anemia (see
VALCYTE (valganciclovir hydrochloride) is contraindicated in patients who are hypersensitive to valganciclovir, ganciclovir or to any ingredient in the formulation, including any non‐medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING . Due to the similarity of the chemical structure of valganciclovir and that of acyclovir and its pro‐ drug valacyclovir, a cross‐hypersensitivity reaction between these drugs is possible.
VALCYTE® (valganciclovir hydrochloride) Page 5 of 56
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Recommended Dose and Dosage Adjustment , Dosage Adjustment, Renal Impairment). The oral dispenser is graduated in mL. A 50 mg dose is equivalent to 1 mL. 2 Recommended Dose and Dosage Adjustment Recommended Dose for the Treatment of CMV Retinitis in Adult Patients with Normal Renal Function Induction Treatment: For patients with active CMV retinitis, the recommended dosage is 900 mg twice a day (with food) for 21 days.
Prolonged induction treatment may increase the risk of bone marrow toxicity (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
Maintenance Treatment:
Following induction treatment, or in patients with inactive CMV retinitis, the recommended dosage is 900 mg once daily (with food). Patients whose retinitis worsens may repeat induction treatment (see Induction Treatment). The duration of maintenance treatment should be determined on an individual basis.
Recommended Dose for the Prevention of CMV Disease in Adult Patients with Solid Organ Transplantation For patients who have received a solid organ transplant, the recommended dose is 900 mg once daily (with food) starting within 10 days of transplantation and continuing until 100 days post‐ transplantation.
Evidence for safety and efficacy of VALCYTE for the prevention of CMV disease in solid organ transplant patients beyond the follow‐up of 6 months post‐transplant is not available.
Dosage Adjustment Reduction of Dose:
Dosage reductions in renally impaired patients are required for VALCYTE (see Renal Impairment). Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see 8 ADVERSE REACTIONS). VALCYTE should not be administered in patients with severe neutropenia (ANC less than 500/μL), severe thrombocytopenia (platelets less than 25,000/μL), or severe anemia (hemoglobin less than 80 g/L).
Renal Impairment:
Serum creatinine or estimated creatinine clearance levels should be monitored carefully. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). The dose‐reduction algorithm was based on predicted ganciclovir exposures.
The range of exposures in renally impaired patients may be greater than in renally sufficient patients. Thus, increased monitoring for cytopenias may be warranted in patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
VALCYTE® (valganciclovir hydrochloride) Page 7 of 56 Patients undergoing hemodialysis: Dosage adjustment is necessary for patients on hemodialysis (CrCl < 10 mL/min) and a dosing recommendation is given in Table 2 below (see 7 WARNINGS AND PRECAUTIONS, Renal, Patients undergoing […]