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Paclitaxel protein-bound Pregnancy and Breastfeeding Warnings

Paclitaxel protein-bound is also known as: Abraxane

Medically reviewed by Last updated on Nov 5, 2020.

Paclitaxel protein-bound Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicities (e.g., intrauterine mortality, increased resorptions, and fetal anomalies). Fetal anomalies in animals included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles. 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: Use is contraindicated.
UK, US: Use should be avoided.

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

-This drug can have genotoxic effects and can cause serious birth defects 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.
-Male patients should seek advice on conservation of sperm prior to treatment due to the risk of irreversible infertility.
-Males treated with this drug should not father a child during and up to 6 months after treatment.

See references

Paclitaxel protein-bound Breastfeeding Warnings

AU, UK: Use is contraindicated.
US: A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Abraxane (paclitaxel protein-bound)." American Pharmaceutical Partners, Schaumberg, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Abraxane (paclitaxel protein-bound)." American Pharmaceutical Partners, Schaumberg, IL.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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