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Palonosetron Pregnancy and Breastfeeding Warnings

Palonosetron is also known as: Aloxi

Medically reviewed by Drugs.com. Last updated on Dec 12, 2018.

Palonosetron Pregnancy Warnings

Animal studies have failed to reveal evidence of embryotoxicity or adverse effects on embryofetal development. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown 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: B1
US FDA pregnancy category: Not assigned.

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Palonosetron Breastfeeding Warnings

Some other drugs in the same class are excreted into animal milk.

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: Unknown

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Aloxi (palonosetron)." MGI Pharma Inc, Minnetonka, MN.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Aloxi (palonosetron)." MGI Pharma Inc, Minnetonka, MN.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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