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GANCICLOVIR FOR is a brand name for Ganciclovir, supplied as a powder for solution. 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.
Ganciclovir for injection is contraindicated in patients who are hypersensitive to ganciclovir, valganciclovir or to any of the excipients (see DOSAGE FORMS, COMPOSITION, AND PACKAGING). Due to the similarity of the chemical structure of ganciclovir and that of acyclovir and its pro- drug valacyclovir, a cross-hypersensitivity reaction between these drugs is possible.
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions • The clinical toxicity of ganciclovir for injection includes severe leukopenia, neutropenia, anemia, and 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. • Ganciclovir for injection is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks stated herein.
• The safety and efficacy of ganciclovir for injection 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 In clinical studies with ganciclovir for injection, the maximum single dose studied has been 6 mg/kg infused intravenously over one hour.
Larger doses have resulted in increased toxicity. It is likely that more rapid infusions would also result in increased toxicity. Administration of ganciclovir for injection should be accompanied by adequate hydration. Since ganciclovir is excreted by the kidneys, normal clearance depends on adequate renal function.
IF RENAL FUNCTION IS IMPAIRED, DOSAGE ADJUSTMENTS ARE REQUIRED. Such adjustments should be based on measured or estimated creatinine clearance values (see DOSAGE AND ADMINISTRATION: Renal Impairment). For patients on hemodialysis (CrCl < 10 mL/min), it is recommended that intravenous ganciclovir be used (see DOSAGE AND ADMINISTRATION: Renal Impairment).
Hemodialysis reduces plasma concentrations of ganciclovir by approximately 50% during a 4 hour hemodialysis session (see DOSAGE AND ADMINISTRATION, Hemodialysis). Ganciclovir for Injection, USP Page 5 of 56 Carcinogenesis and Mutagenesis Ganciclovir caused point mutations and chromosomal damage in mammalian cells in vitro and in vivo, but did not cause point mutations in bacterial or yeast cells, dominant lethality in mice, or morphologically transformed cells in vitro.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4x, respectively, based on area under the plasma concentration curve [AUC] comparisons). The principally affected tissues at the dose of 1000 mg/kg/day were the preputial gland in males, forestomach (nonglandular mucosa) in males and females, and reproductive tissues and liver in females.
At dose of 20 mg/kg/day, slightly increased tumor incidences occurred in the preputial and harderian glands in males, forestomach in males and females, and liver in females. All ganciclovir-induced tumours were of epithelial or vascular origin except for histiocytic sarcoma of the liver.
01x the human dose based on AUC comparison). The preputial and clitoral glands, forestomach and harderian glands of mice have no human counterpart. Ganciclovir should be considered a potential carcinogen in humans. Hematologic Ganciclovir for injection should not be administered if the absolute neutrophil count is less than 500 cells/mcL or the platelet count is less than 25 000 cells/mcL 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 ganciclovir for injection. The frequency and severity of these events vary widely in different patient populations (see WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests; DOSAGE AND ADMINISTRATION, Patients with Severe Leukopenia, Neutropenia, Anemia, Thrombocytopenia and/or Pancytopenia; ADVERSE REACTIONS).
Ganciclovir for injection should therefore, be used with caution in patients with pre-existing cytopenias, or with a history of cytopenic reactions to other drugs, chemicals, or irradiation. It is recommended that complete blood counts including platelet counts be monitored in all patients during therapy, particularly in patients with renal impairment (see WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests).
In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors and/or the interruption of therapy is recommended (see ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION: Patient Monitoring, Reduction of Dose).
Neutropenia:
Neutropenia typically occurs during the first or second week of induction therapy and prior to administration of a total cumulative dose of 200 mg/kg of ganciclovir for injection but may occur at any time during treatment with either formulation.
Evidence of recovery of cell counts usually occurs within 3 to 7 days after discontinuing the drug. Colony stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving ganciclovir for injection for treatment of CMV retinitis.
Thrombocytopenia:
Thrombocytopenia (platelet count of less than 50 000 cells/mcL) was observed in patients treated with ganciclovir for injection. Immunodeficient patients without Ganciclovir for Injection, USP Page 6 of 56 AIDS were more likely to develop lowered platelet counts than those with AIDS.
Patients with initial platelet counts less than 100 000 cells/mcL were also at increased risk of this toxicity of ganciclovir for injection. Renal Monitoring renal function during therapy with ganciclovir for injection is essential, especially for elderly patients and those patients receiving concomitant agents […]