Fosnetupitant / palonosetron Pregnancy and Breastfeeding Warnings

Brand names: Akynzeo for Injection

Medically reviewed by Drugs.com. Last updated on Oct 12, 2023.

Fosnetupitant / palonosetron Pregnancy Warnings

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

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: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies given fosnetupitant daily during organogenesis have revealed evidence of delayed ossification of the pubis, increased resorptions, lower bodyweight in offspring at birth through maturation, and delayed physical development, with some doses producing maternal toxicity. Animal studies given palonosetron during organogenesis have failed to reveal evidence of adverse effects on embryofetal development. There are no controlled data in human pregnancy.

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.

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Fosnetupitant / palonosetron Breastfeeding Warnings

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: Data not available

Comment: The effects on the nursing infant and on maternal milk production are unknown.

See references

Further information

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