Fosaprepitant Pregnancy and Breastfeeding Warnings

Brand names: Emend for Injection, Focinvez

Medically reviewed by Drugs.com. Last updated on Aug 10, 2022.

Fosaprepitant Pregnancy Warnings

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

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.

Comments:
-This drug is rapidly converted to aprepitant after IV administration.
-The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of this drug.
-Patients of childbearing potential using hormonal contraceptives should be advised to use an effective alternative or backup nonhormonal contraceptive (e.g., condoms, spermicides) during therapy and for 1 to 2 months after the last dose; local protocol should be consulted regarding contraception timing.

Animal studies have failed to reveal evidence of embryofetal toxicity, malformations, or postnatal developmental impairment. In rats and rabbits, aprepitant was administered during organogenesis at oral doses up to 1000 mg/kg twice a day (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits); these exposures (AUC) were about equivalent to the exposure at the recommended human dose of 150 mg. No embryofetal lethality or malformations were observed at any dose level in either species. Aprepitant crosses the placenta in rats and rabbits. 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.

See references

Fosaprepitant Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; 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:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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