Yescarta Pregnancy Warnings
Animal studies have not been conducted. 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.
This drug should be used during pregnancy only if the benefit outweighs the risk.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no data on the use of this drug use in pregnant women. 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. Based on the mechanism of action, 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:
-Based on its mechanism of action, this drug may cause fetal toxicity (including B-cell lymphocytopenia) if the transduced cells cross the placenta.
-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.
-Consult the manufacturer product information for fludarabine and cyclophosphamide regarding the need for effective contraception in patients who receive the lymphodepleting chemotherapy.
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