Skip to Content

Paclitaxel protein-bound Pregnancy and Breastfeeding Warnings

Paclitaxel protein-bound is also known as: Abraxane

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 Comments: -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. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.