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Sirolimus Pregnancy and Breastfeeding Warnings

Sirolimus is also known as: Rapamune

Medically reviewed on February 15, 2018

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.

See references

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 references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Rapamune (sirolimus)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. Rapamune (sirolimus)" Wyeth-Ayerst Laboratories, Philadelphia, PA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

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

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