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Anakinra Pregnancy and Breastfeeding Warnings

Anakinra is also known as: Kineret

Medically reviewed on July 9, 2018

Anakinra Pregnancy Warnings

(AU, US): Benefit should outweigh risk.
(UK): Use is not recommended during pregnancy and in women of childbearing potential not using contraception.

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

Animal reproductive studies at doses up to 15 to 30 fold greater (based on body surface area adjusted dose) than the human dose and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women.

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.

See references

Anakinra Breastfeeding Warnings

This drug is recombinant human interleukin-1 receptor antagonist (IL-1Ra). IL-1Ra is a normal component of human milk where it may play a role as an anti-inflammatory agent. No data exist on the excretion of this drug into breastmilk after exogenous administration. One infant was reportedly breastfed during maternal therapy with no obvious adverse effects. However, long-term follow-up data on infants breastfed during maternal use are not available.

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references

References for pregnancy information

  1. "Product Information. Kineret (anakinra)." Amgen, Thousand Oaks, CA.
  2. British Medical Association. Royal Pharmaceutical Society of Great Britain. Joint Formulary Committee "British National Formulary. Available from: URL: http://bnf.org/bnf/"
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

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. Kineret (anakinra)." Amgen, Thousand Oaks, CA.
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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