Breyanzi Pregnancy Warnings
There are no available data with use of this drug in pregnancy. No animal reproductive and developmental toxicity studies have been conducted. It is not known if this drug has the potential to be transferred to the fetus.
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.
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no available data on the use of this drug in animal or human pregnancy. Based on its mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia; therefore, administration is not recommended in pregnancy. If a pregnancy occurs during therapy, the physician should be notified immediately.
Comments:
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-There are insufficient exposure data to provide a recommendation concerning duration of contraception following therapy with this drug.
-There are no data on the effect of this drug on fertility.
See references
