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AURO-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 .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions The clinical toxicity of AURO-VALGANCICLOVIR (Valganciclovir hydrochloride) includes: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure, and aplastic anemia.
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. AURO-VALGANCICLOVIR is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks stated herein.
The safety and efficacy of AURO-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). General The clinical toxicity of 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. AURO-VALGANCICLOVIR is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks.
Safety and efficacy of valganciclovir hydrochloride 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, upon oral administration, valganciclovir is rapidly and extensively converted to ganciclovir. Therefore, like ganciclovir, valganciclovir is a potential carcinogen (see TOXICOLOGY: Carcinogenesis, Mutagenesis for discussion on animal data).
Page 5 of 52 Hematologic Toxicity AURO-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).
AURO-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 AURO-VALGANCICLOVIR (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 AURO- VALGANCICLOVIR.
Such adjustments should be based on measured or estimated creatinine clearance values (see DOSAGE AND ADMINISTRATION: Dosage Adjustment, Renal Impairment).
Patients undergoing hemodialysis:
Dosage adjustment is necessary for patients on hemodialysis (CrCl < 10mL/min) (see DOSAGE AND ADMINISTRATION: Dosing Considerations and Dosage Adjustment).
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 52 administering AURO-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 AURO-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-clincal studies, […]