Bavencio Pregnancy Warnings
Animal studies have not been conducted. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, the risk of administering this drug during pregnancy include increased rates of abortion or stillbirth. Based on its mechanism of action, fetal exposure to this drug may increase the risk of developing immune-related disorders or altering the normal immune response. 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.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated 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 IgG1 immunoglobulins (IgG1) are known to cross the placenta; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.
Comments:
-Females of reproductive potential should use effective contraception during therapy with this drug and for at least 1 month after.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.
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