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Cabazitaxel Pregnancy and Breastfeeding Warnings

Cabazitaxel is also known as: Jevtana

Medically reviewed on January 11, 2018

Cabazitaxel Pregnancy Warnings

Use during pregnancy is considered contraindicated. (AU)
Use is not recommended. (UK, US)

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

Comments:
-Men should use effective contraception throughout treatment and for up to 6 months after the last dose.
-Due to potential exposure via seminal liquid, men should prevent contact with the ejaculate by another person throughout treatment.
-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 hazard to the fetus.

Animal studies have shown that this drug is embryotoxic, fetotoxic, and abortifacient. This drug crosses the placental barrier. There are no adequate or well-controlled studies in pregnant women.

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

Cabazitaxel Breastfeeding Warnings

Approximately 1.5% of the dose administered to the mother is expected to be excreted into maternal milk.

Use is contraindicated (AU)
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (UK, US)

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

Comments: There is a potential for serious adverse reactions in nursing infants.

See references

References for pregnancy information

  1. "Product Information. Jevtana (cabazitaxel)." sanofi-aventis , Bridgewater, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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. "Product Information. Jevtana (cabazitaxel)." sanofi-aventis , Bridgewater, 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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