New 500-mg Tablet Formulation of Invirase (Saquinavir) Approved

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 1,000 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 1,200 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 1,000-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.

For a PDF copy of the complete labeling, click here.

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