Fedratinib Pregnancy and Breastfeeding Warnings

Brand names: Inrebic

Medically reviewed by Drugs.com. Last updated on Sep 28, 2023.

Fedratinib Pregnancy Warnings

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

US FDA pregnancy category: Not assigned.

Risk Summary: In animal reproduction studies, oral administration of this drug to pregnant rats during organogenesis at doses considerably lower than the recommended human daily dose resulted in adverse developmental outcomes including skeletal variations (such as additional ossification center of neuronal arches).

Comments:
-Adequate methods of contraception should be encouraged.
-It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
-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.
-Some experts state that contraception should be used during and for at least 1 month after the last dose of treatment.

Animal studies have revealed evidence of embryotoxicity. 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

Fedratinib Breastfeeding Warnings

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: Data not available

Comments:
-Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during therapy and for at least 1 month after.
-Some experts recommend using an alternative agent (e.g., adalimumab, certolizumab, etanercept, infliximab, tocilizumab) during breastfeeding, especially while nursing a preterm infant or newborn.

See references

Further information

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