Deuruxolitinib Pregnancy and Breastfeeding Warnings

Brand names: Leqselvi

Medically reviewed by Drugs.com. Last updated on Jul 15, 2025.

Deuruxolitinib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on the findings of animal studies, this drug may cause fetal harm during pregnancy.

Comments:
-Available data from clinical trials is not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-Consider pregnancy planning and prevention for females of reproductive potential.
-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 risk to the fetus.

Animal reproduction studies showed reduced fetal weight, increased skeletal malformations, maternal toxicity, decreased pup survival, and adverse effects on postnatal development when administered in 2 separate studies orally to pregnant rats at a dose 4.8 and 5 times the maximum recommended human dose (MRHD). Studies in pregnant rabbits showed maternal toxicity, reduced fetal weight, and increased post-implantation loss when administered during organogenesis period at a dose 0.3 times the MRHD. There are no controlled data in human pregnancy.

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.

See references

Deuruxolitinib Breastfeeding Warnings

Use is not recommended.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-This drug was present in milk of lactating rats, and most likely will be present in human milk.
-Advise women not to breastfeed during treatment and for one day after the last dose (approximately 5 to 6 elimination half-lives).

See references

Further information

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

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