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Darbepoetin alfa Pregnancy and Breastfeeding Warnings

Darbepoetin alfa is also known as: Aranesp

Medically reviewed on Dec 5, 2017

Darbepoetin alfa Pregnancy Warnings

Animal studies have revealed evidence of fetolethality and fetotoxicity. There are no controlled data in human pregnancy.

Women who become pregnant during treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN to enroll.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

AU and US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
UK: Caution is recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

See references

Darbepoetin alfa Breastfeeding Warnings

UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
AU and US: Caution is recommended.

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

Darbepoetin alfa is biologically and immunologically indistinguishable from erythropoietin, a normal component of human milk. IV darbepoetin has been given safely to newborn infants in doses much larger than those expected to appear in breastmilk.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Aranesp (darbepoetin alfa)." Amgen, Thousand Oaks, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Aranesp (darbepoetin alfa)." Amgen, Thousand Oaks, CA.

Further information

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