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Clofarabine Pregnancy and Breastfeeding Warnings

Clofarabine is also known as: Clolar

Medically reviewed on Jan 30, 2017

Clofarabine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.

This drug was teratogenic and fetotoxic in animal studies. Developmental toxicity (reduced fetal body weight and increased postimplantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed at animal doses approximately equivalent to the recommended human dose. 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

Clofarabine Breastfeeding Warnings

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Clolar (clofarabine)." sanofi-aventis, Bridgewater, NJ.

References for breastfeeding information

  1. "Product Information. Clolar (clofarabine)." 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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