The PD-1/PD-L1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the fetus. In animal studies, disruption of PD-L1 signaling resulted in an increase in fetal loss. Exposure to this drug in pregnant animals at levels approximately 6 to 20 times higher than the recommended human dose resulted in premature delivery, fetal loss (abortion and stillbirth), and increased neonatal deaths. This drug crosses the placenta. Immune-mediated disorders have been reported in animal studies. 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.

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug caused an increase in premature delivery, fetal loss, and premature neonatal death in animal studies. Human immunoglobulin G1 (IgG1) crosses the placental barrier; therefore, this drug can be transmitted from the mother to the developing fetus.

Comments:
-This drug can harm a developing fetus.
-Women of childbearing potential should use effective contraception during therapy and for at least 3 months after the last dose.
-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.

See references

Use is not recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown; however, this drug has been associated with premature neonatal death in animal breastfeeding studies.
-Women should be advised not to breastfeed during therapy and for at least 3 months after the last dose.

See references