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Revised labeling for VIREAD (tenofovir disoproxi l fumarate) 300mg Tablets

11/4/2003

Revisions were made recently to the product labeling for VIREAD (tenofovir disoproxil fumarate) 300mg Tablets marketed by Gilead Sciences. The main revisions are summarized below. The revised labeling can be viewed at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

The revised label contains the following changes:

Addition of one paragraph in the "Pharmacokinetics, Special Populations" section about the results of a pharmacokinetics study of tenofovir in non-HIV infected patients with moderate to severe hepatic impairment. The main results of the study are summarized below.

The pharmacokinetics of tenofovir following a 300 mg single dose of VIREAD have been studied in non-HIV infected patients with moderate to severe hepatic impairment. There were no substantial alterations in tenofovir pharmacokinetics in patients with hepatic (liver) impairment compared with unimpaired patients. No change in VIREAD dosing is required in patients with hepatic impairment.
2. Addition of emtricitabine (Emtriva) to the list of drugs that, in combination with VIREAD, have been studied in healthy volunteers. Addition of emtricitabine in Table 2: "Drug Interactions: Changes in Pharmacokinetic Parameters for Tenofovir in the Presence of the Co-administered Drug" and Table 3: "Drug Interactions: Changes in Pharmacokinetic Parameters for Co-administered Drug in the Presence of VIREAD" to reflect most current study data.

In a drug-drug interaction study with tenofovir and emtricitabine, no changes in plasma levels of either tenofovir or emtricitabine were seen.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/01/2014
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