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Saquinavir Pregnancy and Breastfeeding Warnings

Saquinavir is also known as: Fortovase, Invirase

Saquinavir Pregnancy Warnings

The Pediatric AIDS Clinical Trials Group (PACTG) confirmed previous studies that demonstrated a low maternal-to-fetal transfer of protease inhibitors including saquinavir however, nonnucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors showed efficient passage across the placenta. To monitor maternal-fetal outcomes of pregnant women exposed to saquinavir, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA). The Antiretroviral Pregnancy Registry reported prospective data from January 1989 to January 2004 involving 70 live births exposed to saquinavir in combination with other antiretroviral agents during the first trimester and 82 live births exposed during the second or third trimester. Four birth defects were reported from the first trimester exposure and 4 birth defects from the second or third trimester exposure. The registry concluded that there was no pattern to the anomalies.

Saquinavir has been assigned to pregnancy category B by the FDA. Reproduction studies in rats and rabbits have failed to reveal evidence of teratogenicity or embryotoxicity. There are no controlled data in human pregnancy. Saquinavir should only be given during pregnancy when benefit outweighs risks.

Saquinavir Breastfeeding Warnings

There are no data on the excretion of saquinavir into human milk. The manufacturer recommends that due to the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should not breast-feed while taking saquinavir. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.

References for breastfeeding information

  1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institute of Health "Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Available from: URL:" ([2011 Sep 14]):
  2. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  3. "Product Information. Fortovase (saquinavir)" Roche Laboratories, Nutley, NJ.

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