Experience With Valcyte 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 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 [see CLINICAL 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

Valcyte 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: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.