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FDA
Approves New 500 mg Tablet Formulation of PI Saquinavir (Invirase)
On
December 17, 2004, FDA approved a new 500 mg tablet formulation
of the HIV protease
inhibitor saquinavir (Invirase). Invirase is a product of
Roche Laboratories, Inc., of Nutley, New Jersey.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.
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
The new formulation of Invirase, which
was approved under a six-month priority FDA review, will reduce
pill count for each dose by more than half (from five pills to two
pills taken twice-daily) compared to the current formulation of
Invirase 200 mg capsules. “Today’s approval is one in a long line
of milestones that illustrate the Roche heritage of innovation in
HIV,” said Malte Schultz, M.D., Medical Director, Roche. “The new
500 mg tablet formulation makes INVIRASE an attractive option for
HIV patients across the treatment spectrum, from those just beginning
therapy to those with prior treatment experience.”
Articles
on Invirase and Fortovase on HIV and Hepatitis.com.
Complete
Product Information on Invirase
Patient
Information 
Invirase Product Site
01/03/05
Sources
R
Klein and K Struble. Office of Special Health Issues. US Food and
Drug Administration.
www.rocheusa.com
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