Jemperli Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered during pregnancy. Animal studies have revealed fetal exposure to this drug may increase the risk of developing immune-mediated rejection of the developing fetus, resulting in fetal death.
Comments:
-This drug can harm a developing fetus.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 4 months after the last dose.
Animal studies have revealed that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Human IgG4 immunoglobulins (IgG4) are known to cross the placental barrier; therefore, this drug has the potential to be transmitted from the mother to the developing fetus. 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.
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