Penpulimab Pregnancy and Breastfeeding Warnings

Penpulimab Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: This drug can cause fetal harm when administered to a pregnant woman.

Comments:
-No data are available on the use of this product in pregnant women, however, based on its mechanism of action, this drug can cause fetal harm if used during pregnancy.
-Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, this drug can be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.

Animal studies have not been conducted. A main function of programmed death receptor-1 (PD-1) and PD-ligand 1 (PD-L1) pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, the blockade of PD-L1 signaling showed to disrupt tolerance to the fetus and to result in an increase in fetal loss. Administering this drug during pregnancy potentially increases the risk of abortion or stillbirth. There were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; but immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to this drug can increase the risk of developing immune-mediated disorders or of altering the normal immune response. 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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Penpulimab Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Data not available
Excreted into animal milk: Unknown

Comments:
-There is no information regarding the presence of this drug in human milk, the effects on a breastfed infant, or effects on milk production.
-Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child are unknown.
-Due to the potential for serious adverse reactions in a breastfed child, it is recommended not to breastfeed during treatment and for 4 months after the last dose of this drug.

See references

Further information

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