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Roche Discontinues Fortovase for Invirase: Dear Health Care Provider Letter
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Dear Health Care Professional:
Roche Pharmaceuticals would like to inform you that the sale and distribution of Fortovase-the 200-mg soft-gel formulation of saquinavir-will be discontinued by February 15, 2006. Roche has taken this action because the clinical demand for Fortovase has declined significantly; this is not the result of any safety or efficacy issues regarding the product.
Invirase, which is the preferred formulation of saquinavir, will continue to be available in 200-mg and 500-mg formulations. Invirase offers patients key advantages over Fortovase, including:
--Lower pill burden-approved dosing for 500-mg Invirase is 1000 mg twice-daily with 100 mg of ritonavir BID (3 pills twice daily or a total count of 6 pills)
--Improved GI tolerability (less diarrhea and vomiting) [1] -Department of Health and Human Services (DHHS) Guidelines state: The hard gel capsule appears to have much better gastrointestinal tolerance than the soft gel preparation."[2]
--Smaller capsules/tablets-both 200-mg and 500-mg Invirase formulation are smaller in size than Fortovase capsules.
--No need for refrigeration.
At this time we encourage physicians to refrain from starting Fortovase treatment in their HIV-positive patients. IF you are aware of a patient receiving Fortovase, please notify the prescribing health care provider (if someone other than yourself) and the patient regarding this announcement. We encourage you or the prescribing health care provider to discuss appropriate alternative treatment regimens with your patients currently receiving Fortovase.
Enclosed you will find the complete Product Information for Invirase (saquinavir mesylate). If you have any questions regarding the discontinuation of Fortovase, please call 1-800-526-6367.
Please see important safety information at close of letter.
Sincerely,
Lars E. Birgerson, MD, PhD
Vice President, Medical Affairs
References:
1. Kurowski M, Sternfeld T, Sawyer A, et al. Pharmacokinetic and tolerability of twice-daily saquinavir hard gelatin capsules and saquinavir soft gelatin capsules boosted with ritonavir in healthy volunteers. HIV Med. 2003;4(2):94-100.
2. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Panel on Clincial Practices for Treatment of HIV Infection, Unites States Department of Health and Human Services; October 29, 2004.
Source
Roche Pharmaceuticals. "Dear Health Care Professional." May 2005.
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