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Ruxolitinib Pregnancy and Breastfeeding Warnings

Ruxolitinib is also known as: Jakafi

Medically reviewed on May 11, 2018

Ruxolitinib Pregnancy Warnings

In animal studies, treatment with ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

AU TGA pregnancy category: C
US FDA pregnancy category: C

Effective methods of contraception are recommended for women of child-bearing potential during treatment.

See references

Ruxolitinib Breastfeeding Warnings

Ruxolitinib and/or its metabolites were excreted into the milk of lactating rats at a concentration that was 13-fold higher than the maternal plasma level.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Jakafi (ruxolitinib)." Incyte Corporation, Wilmington, DE.
  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. Jakafi (ruxolitinib)." Incyte Corporation, Wilmington, DE.

Further information

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

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