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Epoetin alfa Pregnancy and Breastfeeding Warnings

Epoetin alfa is also known as: Epogen, Procrit

Epoetin alfa Pregnancy Warnings

Animal studies have revealed increased pre and post-implantation loss, decreased live fetuses, and evidence of fetotoxicity. There are no controlled data in human pregnancy. Women who become pregnant during treatment with this drug are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN to enroll. (US) 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.

Use of preparations containing benzyl alcohol is contraindicated; benzyl alcohol-free preparations should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: This drug is not recommended in pregnant surgical patients participating in an autologous blood predonation program.

See references

Epoetin alfa Breastfeeding Warnings

US: Use of preparations containing benzyl alcohol is contraindicated; caution is recommended with benzyl alcohol-free preparations. 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: This drug should be used only if clearly needed. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: This drug is not recommended in lactating surgical patients participating in an autologous blood predonation program.

See references

References for pregnancy information

  1. "Product Information. Epogen (epoetin alfa)." Amgen, Thousand Oaks, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc, Raritan, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Epogen (epoetin alfa)." Amgen, Thousand Oaks, CA.
  4. "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc, Raritan, NJ.

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