Valcyte (Valganciclovir Hcl) Drug Information: Overdosage and Contraindications

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May 27, 2012

Valcyte

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OVERDOSE

Experience With Valcyte (valganciclovir hcl) Tablets: One adult developed fatal bone marrow depression (medullary aplasia) after several days of dosing that was at least 10-fold greater than recommended for the patient's estimated degree of renal impairment.

An overdose of Valcyte (valganciclovir hcl) could also possibly result in increased renal toxicity [see DOSAGE AND ADMINISTRATION, Use in Specific Populations].

Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of Valcyte [see CLINICAL PHARMACOLOGY]. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered [seeCLINICAL PHARMACOLOGY].

Experience With Intravenous Ganciclovir: Reports of overdoses with intravenous ganciclovir have been received from clinical trials and during postmarketing experience. The majority of patients experienced one or more of the following adverse events:

Hematological toxicity: pancytopenia, bone marrow depression, medullary aplasia, leukopenia, neutropenia, granulocytopenia

Hepatotoxicity: hepatitis, liver function disorder

Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine

Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting

Neurotoxicity: generalized tremor, convulsion

CONTRAINDICATIONS

Valcyte (valganciclovir hcl) is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see ADVERSE REACTIONS].

Last reviewed on RxList: 9/8/2010
This monograph has been modified to include the generic and brand name in many instances.