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Ruxolitinib Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Mar 29, 2022.

Ruxolitinib is also known as: Jakafi

Ruxolitinib Pregnancy Warnings

In animal studies, treatment-related malformations were not observed with administration to pregnant rats and rabbits during the period of organogenesis, but adverse developmental outcomes such as decreased fetal weights (rats and rabbits) and increased late resorptions (rabbits) were observed 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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: N

Risk Summary: There are no studies in pregnant women to inform drug-associated risks; animal studies have shown adverse developmental outcomes.

Comments:
-Effective methods of contraception are recommended for women of child-bearing potential during treatment.
-Some authorities contraindicate the use of this drug during pregnancy.

See references

Ruxolitinib Breastfeeding Warnings

There is no information on the clinical use of this drug during breastfeeding. This drug 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. This drug is highly bound to plasma proteins so the amount in milk is likely to be low, however, due to the potential for serious adverse events in the breastfed infant, breastfeeding is not recommended.

Not recommended

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

Comments:
-Because of the potential for thrombocytopenia and anemia, breastfeeding should be discontinued during treatment and for 2 weeks after the final dose.

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. "Product Information. Jakafi (ruxolitinib)." Incyte Corporation, Wilmington, DE.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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