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Etanercept Pregnancy and Breastfeeding Warnings

Etanercept is also known as: Enbrel, Erelzi

Etanercept Pregnancy Warnings

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

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

Comments:
-Women of childbearing potential should be advised to use appropriate contraception during therapy and for 3 weeks after discontinuation of therapy.
-This drug crosses the placenta and has been detected in the serum of infants born to female patients treated during pregnancy. The clinical impact of this is unknown; however, infants may be at increased risk of infection.
-Administration of live vaccines to infants for 16 weeks after the mother's last dose of this drug is generally not recommended.

Developmental toxicity studies performed in animals have revealed no evidence of harm to the fetus. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Etanercept Breastfeeding Warnings

This drug is minimally excreted into breastmilk and poorly absorbed by the infant, which would be expected because of its high molecular weight. Some experts feel that the drug is a low risk to the nursing infant and can be given during breastfeeding.

Women who choose to continue treatment while nursing are encouraged to enroll in Amgen's Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Enbrel (etanercept)." 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. Enbrel (etanercept)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. 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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