Ruxolitinib topical Pregnancy and Breastfeeding Warnings

Brand names: Opzelura

Ruxolitinib topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of fetal harm. Developmental adverse effects during organogenesis were observed after the oral administration of this drug at doses linked to maternal toxicity. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting: https://opzelura.pregnancy.incyte.com/.

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.

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Ruxolitinib topical Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 4 weeks after the last dose.

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

Since this drug is present in animal milk, it is likely that the drug will be present in human milk. Because this drug is 97% bound to plasma proteins, the amount in milk is likely to be low. Rat studies showed the presence of this drug and several of its metabolites in milk at levels higher than those in maternal plasma.

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Further information

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

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