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Paclitaxel Pregnancy and Breastfeeding Warnings

Paclitaxel is also known as: Onxol, Taxol

Medically reviewed by Drugs.com. Last updated on Mar 30, 2020.

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 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.

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Administration during organogenesis to rabbits at doses of 3 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m2 basis) caused embryotoxicity and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, and increased fetal deaths. Maternal toxicity was also observed at this dose. No teratogenic effects were observed at 1 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m2 basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality.

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.

-Male patients should seek advice regarding conservation of sperm prior to therapy with this drug because of the possibility of infertility.

See references

Paclitaxel Breastfeeding Warnings

Use is contraindicated.

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

Comments:
Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.

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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Paclitaxel (PACLitaxel)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  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.