"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
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.
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:
Hepatotoxicity: hepatitis, liver function disorder
Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting
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.
Additional Valcyte Information
Valcyte - User Reviews
Valcyte User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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