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MINT-VALGANCICLOVIR 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: AND CLINICAL USE ..........................................................................................3 CONTRAINDICATIONS ...............................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
MINT-VALGANCICLOVIR (valganciclovir hydrochloride) is administered orally, and should be taken with food (see ACTION AND CLINICAL PHARMACOLOGY: Pharmacokinetics, Absorption). After oral administration, valganciclovir is rapidly and extensively converted into the active ingredient ganciclovir.
The bioavailability of ganciclovir from MINT-VALGANCICLOVIR is significantly higher than from oral ganciclovir. MINT-VALGANCICLOVIR is not recommended in patients on hemodialysis (CrCl < 10 mL/min) because appropriate dosage adjustment is not possible.
Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression and aplastic anemia have been observed in patients treated with valganciclovir hydrochloride tablets (and ganciclovir). Due to the frequency of leukopenia, granulocytopenia (neutropenia), anemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anemia in patients taking valganciclovir hydrochloride, 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.
Page 25 of 56 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 WARNINGS AND PRECAUTIONS: Hematologic Toxicity).
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.
General The clinical toxicity of MINT-VALGANCICLOVIR (valganciclovir hydrochloride) includes granulocytopenia, anemia and thrombocytopenia. In animal and in-vitro studies ganciclovir was mutagenic, carcinogenic, teratogenic and caused aspermia.
Therefore it should be considered a potential teratogen and carcinogen in humans. MINT- VALGANCICLOVIR is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks. Safety and efficacy of MINT-VALGANCICLOVIR have not been established for congenital or neonatal CMV disease; nor for the treatment of established CMV disease other than retinitis; nor for use in non-immunocompromised individuals.
Strict adherence to dosage recommendations is essential to avoid overdose.
Specific Solid Organ Transplant (SOT) Subgroups Liver:
In an unpowered subanalysis of the SOT study, PV16000, there was a higher incidence of tissue-invasive CMV disease in liver transplant patients treated with valganciclovir hydrochloride compared with the oral ganciclovir group (see CLINICAL TRIALS).
The clinical significance of this is unknown.
Other:
The safety and efficacy of valganciclovir hydrochloride for the prevention of CMV disease in other SOT patients not mentioned in the INDICATIONS & CLINICAL USE section, such as lung transplant patients, have not been established. Carcinogenesis and Mutagenesis No long-term carcinogenicity studies have been conducted with valganciclovir.
However, upon oral administration, valganciclovir is rapidly and extensively converted to ganciclovir. Therefore, like ganciclovir, valganciclovir is a potential carcinogen (see TOXICOLOGY: Carcinogenesis, Serious Warnings and Precautions The clinical toxicity of MINT-VALGANCICLOVIR (valganciclovir hydrochloride) includes: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure, and aplastic anemia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Valganciclovir in Canada.
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Evidence for safety and efficacy of valganciclovir hydrochloride 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 MINT- VALGANCICLOVIR (see Renal Impairment). Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE REACTIONS).
MINT-VALGANCICLOVIR 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. Dosage adjustment is required for adult patients based on creatinine clearance as shown in Tables 7and 8 below (see WARNINGS AND PRECAUTIONS: Renal and ACTION AND CLINICAL PHARMACOLOGY: 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 WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests).
Page 26 of 56 Patients undergoing hemodialysis:
MINT-VALGANCICLOVIR is not recommended in patients on hemodialysis (CrCl < 10 mL/min) because appropriate dosage adjustment is not possible. 85 x male value Missed Dose The missed dose should be taken as soon as remembered, then the regular dosing schedule should be continued.
Two doses of MINT-VALGANCICLOVIR should not be taken at the same time. Page 27 of 56 Administration MINT-VALGANCICLOVIR should be administered orally, and should be taken with food (see ACTION AND CLINICAL PHARMACOLOGY: Absorption).
OVERDOSAGE Overdose Experience with Valganciclovir hydrochloride Tablets and with Intravenous Ganciclovir Ganciclovir is readily removable by hemodialysis. Data obtained during intermittent haemodialysis in […]
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. MINT-VALGANCICLOVIR is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks stated herein.
The safety and efficacy of MINT-VALGANCICLOVIR have not been evaluated for congenital or neonatal CMV disease, nor for treatment of CMV infection in non- immunocompromised individuals (see INDICATIONS AND CLINICAL USE). Page 5 of 56 Mutagenesis for discussion on animal data).
Hematologic Toxicity MINT-VALGANCICLOVIR should not be administered 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 80 g/L. Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anemia have been observed in patients treated with valganciclovir tablets (and ganciclovir) (see WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION: Dosing Considerations).
MINT-VALGANCICLOVIR should, therefore, be used with caution in patients with pre- existing hematological cytopenias, a history of drug-related hematological cytopenia, or who have received or are receiving myelosuppressive drugs or irradiation.
Cytopenia may occur at any time during treatment and may increase with continued dosing. Cell counts usually begin to recover within 3 to 7 days of discontinuing drug. Colony-stimulating factors have been shown to increase neutrophil counts in patients receiving ganciclovir for treatment of CMV retinitis.
Due to the frequency of neutropenia, anemia and thrombocytopenia in patients receiving valganciclovir hydrochloride (see ADVERSE REACTIONS), complete blood counts with diferential and platelet counts should be performed frequently, especially in patients with renal impairment and especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/μL at the beginning of treatment.
Thrombocytopenia Patients with low baseline platelet counts (<100,000 /μl) have an increased risk of developing thrombocytopenia. Patients with iatrogenic immunosuppression due to treatment with immunosuppressive drugs are at greater risk of thrombocytopenia than patients with HIV.
Severe thrombocytopenia may be associated with potentially life-threatening bleeding. (see ADVERSE REACTIONS). Renal Since ganciclovir is excreted by the kidneys, normal clearance depends on adequate renal function. If renal function is impaired, dosage adjustments are required for MINT- VALGANCICLOVIR.
Such adjustments should be based on measured or estimated creatinine clearance values (see DOSAGE AND ADMINISTRATION: Dosage Adjustment, Renal Impairment).
Patients undergoing hemodialysis:
MINT-VALGANCICLOVIR is not recommended in patients on hemodialysis (CrCl < 10 mL/min) because appropriate dosage adjustment is not possible.
Acute Kidney Injury Acute kidney injury may occur in:
Elderly patients with or without reduced renal function. Caution should be exercised when Page 6 of 56 administering MINT-VALGANCICLOVIR to geriatric patients, and dosage reduction is recommended for those with impaired renal function (see DOSAGE AND ADMINISTRATION: Dosage Adjustment, Renal Impairment).
Patients receiving potential nephrotoxic drugs. Caution should be exercised when administering MINT-VALGANCICLOVIR to patients receiving potential nephrotoxic drugs. Patients without adequate hydration. Adequate hydration should be maintained for all patients.
Sexual Function/Reproduction Mutagenesis and Carcinogenesis In animal studies, ganciclovir was found to be mutagenic and carcinogenic. Valganciclovir should, therefore, be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers (see SPECIAL HANDLING INSTRUCTIONS).
Impairment of Fertility Based on non-clinical […]