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Docetaxel Pregnancy and Breastfeeding Warnings

Docetaxel is also known as: Docefrez, Taxotere

Medically reviewed on June 11, 2018

Docetaxel Pregnancy Warnings

Use is not recommended.
-According to some authorities use is contraindicated.

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

Comments:
-This drug can harm a developing fetus.
-Women of childbearing potential should be advised to use effective contraception during therapy.
-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.
-Men being treated with this drug should be advised not to father a child during and for up to 6 months following therapy.
-This drug has genotoxic effects and may alter male fertility; therefore, men should seek advice on conservation of sperm prior to receiving this drug.

Animal studies have revealed evidence of embryotoxicity and fetotoxicity. Based on its mechanism of action, this drug is expected to cause fetal harm when administered to a pregnant woman. 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

Docetaxel Breastfeeding Warnings

Radioactivity has been detected in milk following IV administration of this drug in animal studies; offspring receiving 1.5 mg/m2/day IV during late gestation and lactation showed signs of delayed development. No information is available on the use of this drug in humans during breastfeeding.

Use is not recommended.
-According to some authorities use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

See references

References for pregnancy information

  1. "Product Information. Docetaxel (DOCEtaxel)." Hospira Inc, Lake Forest, IL.
  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. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Docetaxel (DOCEtaxel)." Hospira Inc, Lake Forest, IL.

Further information

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

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