Brexucabtagene autoleucel Pregnancy Warnings
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. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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: Based on the mechanism of action of this drug, if the transduced cells cross the placenta, they may cause fetal toxicity, including B cell lymphocytopenia; therefore, it is not recommended for women who are pregnant.
Comments:
-This drug can harm a developing fetus.
-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 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 female or male fertility.
See references
