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Paclitaxel Pregnancy and Breastfeeding Warnings

Paclitaxel is also known as: Onxol, Taxol

Medically reviewed on August 4, 2017.

Paclitaxel Pregnancy Warnings

This drug has been shown to be both embryotoxic and fetotoxic in animal studies. 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.

AU, UK: Use is contraindicated.
US: Use should be avoided.

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

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.
-Women of childbearing potential should be advised to avoid becoming pregnant while receiving this drug and for 6 months after completing therapy.
Male patients should seek advice regarding of sperm prior to therapy with this drug because of the possibility of infertility.
-Males treated with this drug should not father a child during and up to 6 months

See references

Paclitaxel Breastfeeding Warnings

AU, UK: Use is contraindicated.
US: Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. Based on limited data, this drug appears to be excreted into milk in relatively large amounts. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.

See references

References for pregnancy information

  1. "Product Information. Paclitaxel (PACLitaxel)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  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. 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 -]):
  4. "Product Information. Paclitaxel (PACLitaxel)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

Further information

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

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