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Axitinib Pregnancy and Breastfeeding Warnings

Axitinib is also known as: Inlyta

Axitinib Pregnancy Warnings

Use is not recommended

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

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.
-Women of childbearing potential should be advised to avoid becoming pregnant during therapy and for up to 4 weeks following therapy.
-Both male and female patients should be counseled to use effective birth control during treatment.

As angiogenesis is a critical component of embryonic and fetal development, this drug is expected to cause fetal harm if administered to pregnant women. Animal studies have revealed evidence of teratogenicity, embryotoxicity, and fetotoxicity in mice at maternal exposures that were lower than expected human exposures. 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.

See references

Axitinib 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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

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

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Inlyta (axitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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