Sirolimus Pregnancy and Breastfeeding Warnings
Brand names: Rapamune
Medically reviewed by Drugs.com. Last updated on Feb 5, 2024.
Sirolimus Pregnancy Warnings
This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comment:
-This drug may cause immunosuppression in the infant.
-Effective contraception should be initiated before therapy, during therapy, and for 12 weeks after therapy has been stopped.
-Azoospermia has been reported with the use of this drug and has been reversible upon discontinuation in most cases.
This drug was embryo/fetotoxic in animal studies when given in doses approximately 0.2 to 0.5 times the human doses (adjusted for body surface area). Embryo/fetotoxicity was manifested as mortality and reduced fetal weights (with associated delays in skeletal ossification). No teratogenesis was evident. Human data are not available.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Sirolimus Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Data not available
Excreted into animal milk: Yes
Comment:
-Because almost no information is available on the use of this drug during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
See also
References for pregnancy information
- (2001) "Product Information. Rapamune (sirolimus)." Wyeth-Ayerst Laboratories
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- (2001) "Product Information. Rapamune (sirolimus)." Wyeth-Ayerst Laboratories
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
- 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
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.