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Fosaprepitant Pregnancy and Breastfeeding Warnings

Fosaprepitant is also known as: Emend for Injection

Medically reviewed on Apr 25, 2018

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 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.

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

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk summary: There are insufficient data available with use of this drug in pregnant women to inform a drug-related risk.

Comment: 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. "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.
  4. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):

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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