Saquinavir Pregnancy and Breastfeeding Warnings
Brand names: Fortovase, Invirase
Saquinavir Pregnancy Warnings
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.
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.
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 also
References for pregnancy information
- (2001) "Product Information. Invirase (saquinavir)." Roche Laboratories
- Marzolini C, Kim RB (2005) "Placental transfer of antiretroviral drugs." Clin Pharmacol Ther, 78, p. 118-22
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2007) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf
- EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
- Cerner Multum, Inc. "Australian Product Information."
- HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission (2015) 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. https://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf
- Melbourne: Therapeutic Guidelines Limited (2015) eTG complete [Online] http://online.tg.org.au/complete/desktop/tgc.htm
- Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health
References for breastfeeding information
- Fairbrothers D, Kirby E, Lester RM, Wegmann PC, Marshall F, Parkin WE (1985) "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, p. 721-34
- Newell ML, Dunn D, Peckham CS, Ades AE, Pardi G, Semprini AE (1992) "Risk factors for mother-to-child transmission of HIV-1." Lancet, 339, p. 1007-12
- (2001) "Product Information. Invirase (saquinavir)." Roche Laboratories
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
- Cerner Multum, Inc. "Australian Product Information."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- (2013) "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics, 131, p. 391-6
- HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission (2015) 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. https://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf
- Melbourne: Therapeutic Guidelines Limited (2015) eTG complete [Online] http://online.tg.org.au/complete/desktop/tgc.htm
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.