• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Consumers

  • Print
  • Share
  • E-mail

New Dosing Regimens for INVIRASE and FORTOVASE (saquinavir)

12/29/2003

The FDA approved, on December 24, 2003, new dosing regimens for the two available formulations of saquinavir, INVIRASE and FORTOVASE. The newly approved dosing regimen for saquinavir (both INVIRASE and FORTOVASE) is 1000 mg BID (two times a day) co-administered with ritonavir 100 milligrams bid.

For INVIRASE, the new, ritonavir boosted regimen replaces the previously approved regimen. As stated in the revised label, INVIRASE should never be used without ritonavir.

For FORTOVASE, the ritonavir boosted regimen allows a reduced pill burden and ease of administration compared to the previously approved regimen. Unboosted FORTOVASE, however remains a dosage option for patients who are unable to tolerate ritonavir.

The approval of the new dosing regimens were based on pharmacokinetic and safety data. Both boosted regimens of saquinavir provide plasma concentrations exceeding that of unboosted FORTOVASE.

Important changes in the INVIRASE and FORTOVASE labels include drug interaction information relevant to the co-administration of ritonavir.

The revised labeling will be available in the coming weeks through the index at http://www.fda.gov/cder/approval/index.htm

Hoffmann-La Roche of Nutley, NJ is the manufacturer of INVIRASE and FORTOVASE .

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration