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Anakinra Pregnancy and Breastfeeding Warnings

Anakinra is also known as: Kineret

Medically reviewed by Last updated on Apr 6, 2021.

Anakinra Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Available data on the use of this drug in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage, or maternal and fetal adverse events. There are risks to the mother and fetus associated with active rheumatoid arthritis or Cryopyrin-Associated Periodic Syndromes (CAPS).

-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal reproductive studies in rats and rabbits during organogenesis at doses up to 25-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. Published data suggest the risk of adverse pregnancy outcomes in women with rheumatoid arthritis or CAPS is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 grams), and small for gestational age at birth.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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: Unknown

See references

References for pregnancy information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):
  2. "Product Information. Kineret (anakinra)." Amgen, Thousand Oaks, CA.
  3. British Medical Association. Royal Pharmaceutical Society of Great Britain. Joint Formulary Committee "British National Formulary. Available from: URL:"

References for breastfeeding information

  1. "Product Information. Kineret (anakinra)." Amgen, Thousand Oaks, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

Further information

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