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Crizotinib Pregnancy and Breastfeeding Warnings

Crizotinib is also known as: Xalkori

Medically reviewed on March 31, 2017

Crizotinib Pregnancy Warnings

The drug may cause fetal harm and may impair reproductive function and fertility. Animal studies have revealed evidence of embryofetotoxicity, postimplantation loss, and reduced fetal body weights, but have failed to show teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments: Women of childbearing potential and men who are receiving this drug should be advised to use appropriate contraceptive measures during drug therapy and for at least 90 days after therapy completion.

See references

Crizotinib 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: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Xalkori (crizotinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Xalkori (crizotinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. 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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