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Saquinavir Pregnancy and Breastfeeding Warnings

Saquinavir is also known as: Fortovase, Invirase

Medically reviewed on Mar 20, 2018

Saquinavir Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity or embryotoxicity. Placental transfer to the fetus has been reported as low (cord blood/maternal delivery plasma drug ratio less than 0.3). There are no controlled data in human pregnancy.

The Pediatric AIDS Clinical Trials Group (PACTG) confirmed previous studies that showed minimal transplacental passage of this drug.

This drug is not recommended as part of initial combination therapy for antiretroviral-naive pregnant women; it requires baseline ECG (due to potential PR and QT prolongation), has a large pill burden, and is not recommended as part of initial therapy for nonpregnant patients.

To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com

The APR has received prospective reports of about 400 exposures to saquinavir-containing regimens. Too few first-trimester exposures to this drug (less than 200) have been monitored to accurately calculate prevalence of birth defects in exposed cases.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments:
-A pregnancy exposure registry is available.

See references

Saquinavir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant are unknown.
-The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.
-Local guidelines should be consulted if replacement feeding is not an option.

See references

References for pregnancy information

  1. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Invirase (saquinavir)." Roche Laboratories, Nutley, NJ.
  7. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "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: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pe" ([2015 Aug 6]):
  8. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  9. Marzolini C, Kim RB "Placental transfer of antiretroviral drugs." Clin Pharmacol Ther 78 (2005): 118-22

References for breastfeeding information

  1. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  2. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. Newell ML, Dunn D, Peckham CS, Ades AE, Pardi G, Semprini AE "Risk factors for mother-to-child transmission of HIV-1." Lancet 339 (1992): 1007-12
  7. "Product Information. Invirase (saquinavir)." Roche Laboratories, Nutley, NJ.
  8. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "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: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pe" ([2015 Aug 6]):
  9. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  10. Fairbrothers D, Kirby E, Lester RM, Wegmann PC, Marshall F, Parkin WE "Recommendations for assisting in the prevention of perinatal transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus and AIDS." MMWR Morb Mortal Wkly Rep 34 (1985): 721-34

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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