Besremi Pregnancy Warnings
Use is not recommended
US FDA pregnancy category: Not assigned
Risk summary: This drug may cause embryofetal harm when administered to a pregnant woman. Data in human pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; but based on mechanism of action, this drug should be assumed to have abortifacient potential.
Comments:
-Pregnancy testing is recommended prior to treatment.
-Women of childbearing potential should be advised on the risks of embryo-fetal harm and advised to use effective contraception during and for at least 8 weeks after the final dose.
Animal studies have not been conducted but based on its mechanism of action and the role of interferon alfa in pregnancy and fetal development, this drug should be assumed to have abortifacient potential. There are no controlled data in human pregnancy.
Clinical Considerations: Untreated polycythemia vera during pregnancy is associated with adverse maternal outcomes such as thrombosis and hemorrhage; adverse pregnancy outcomes associated with polycythemia vera include increased risk for miscarriage.
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
Besremi Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-Breastfeeding should be avoided with maternal use of this drug; women should be advised not to breastfeed during treatment and for 8 weeks after the final dose.
-A decision should be made to discontinue breastfeeding or abstain from therapy, considering the benefits of breastfeeding for the child and the importance of the treatment to the mother.
See references
