Netupitant / palonosetron Pregnancy and Breastfeeding Warnings

Brand names: Akynzeo

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

Netupitant / palonosetron Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-Some experts recommend: Use is contraindicated.

AU TGA pregnancy category: B3
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:
-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.
-Some experts state that pregnancy tests should be performed on all premenopausal women of childbearing potential, and effective contraception should be used in this patient population during and for up to 1 month after treatment.

Animal studies given netupitant daily during organogenesis have revealed evidence of external and skeletal abnormalities (e.g., positional limb and paw abnormalities, fused sternebrae) at doses of at least 10 mg/kg/day, and reduced fetal weight occurred at maternally toxic doses. Animal models given lower doses of netupitant have not revealed evidence of adverse effects on embryofetal development. 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.

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 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

Netupitant / 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: Yes (netupitant); Data not available (palonosetron)

Comments:
-The effects in the nursing infant and on maternal milk production are unknown.
-Some experts recommend discontinuing breastfeeding during and for 1 month after the last dose of this drug.

See references

Further information

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

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