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Revised Labeling for Viread (Tenofovir Disoproxil Fumarate) 300 mg Tablets

November 4, 2003

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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 in the attached Portable Document Format (pdf) file.

To view or print the document, use Adobe Acrobat Reader, which is free and available directly from Adobe's Website, www.adobe.com/products/acrobat/readstep2.html.

The revised label contains the following changes:

  1. 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.

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  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.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 
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