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Fosaprepitant Pregnancy and Breastfeeding Warnings

Fosaprepitant is also known as: Emend for Injection

Fosaprepitant Pregnancy Warnings

Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, malformations, or postnatal development impairment. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: B

Comments: Effective contraception (at least 2 reliable forms) is required during therapy and for 1 to 2 months after the last dose; local protocol should be consulted regarding contraception timing.

See references

Fosaprepitant Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

Significant concentrations of this drug were found in the breastmilk of animal models, though there are no data regarding the presence of this drug in human milk, its effects on the breastfed infant, or on lactation.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Emend for Injection (fosaprepitant)." Merck & Company Inc, West Point, PA.

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. Emend for Injection (fosaprepitant)." Merck & Company Inc, West Point, PA.

Further information

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

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