You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not respond to this message.
__________________________________________________________

FDA approved, on December 17, 2004, a new 500 mg tablet formulation of the HIV protease inhibitor, INVIRASE (saquinavir mesylate). The dosage and administration for INVIRASE in adults (over the age of 16 years) is 1000 mg twice a day (taken as either two 500 mg tablets or five 200 mg capsules) in combination with ritonavir 100 mg twice a day, after a meal.  The new tablet formulation reduces the pill burden compared to the capsule formulation.

Below is the DOSAGE AND ADMINISTRATION section as it appears in the package insert.

DOSAGE AND ADMINISTRATION

INVIRASE (saquinavir mesylate) capsules and FORTOVASE (saquinavir) soft gelatin capsules are not bioequivalent and cannot be used interchangeably. INVIRASE may be used only if it is combined with ritonavir, because it significantly inhibits saquinavir's metabolism to provide plasma saquinavir levels at least equal to those achieved with FORTOVASE at the recommended dose of 1200 mg tid. When using saquinavir as the sole protease inhibitor in an antiretroviral regimen, FORTOVASE is the recommended formulation (see CLINICAL PHARMACOLOGY: Drug Interactions).

Adults (Over the Age of 16 Years)
*       INVIRASE 1000-mg bid (5 x 200-mg capsules or 2 x 500-mg tablets) in combination with ritonavir 100-mg bid.
*       Ritonavir should be taken at the same time as INVIRASE.
*       INVIRASE and ritonavir should be taken within 2 hours after a meal

A pdf copy of the complete labeling is attached.

Invirase is a product of Roche Laboratories, Inc., of Nutley, New Jersey.

  <<invirasefinal.pdf>>

To view or print the document, you can use the free Adobe Acrobat, available directly from Adobe's Website with full installation instructions.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

An archive of past list serve announcements is available on the FDA web site at http://www.fda.gov/oashi/aids/listserve/archive.html

To UNSUBSCRIBE from this list, or change your e-mail address, please go to
http://list.nih.gov/cgi-bin/wa?SUBED1=fda-hiv-aids&A=1