Toripalimab Pregnancy and Breastfeeding Warnings

Brand names: Loqtorzi

Toripalimab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary:
Based on its mechanism of action, this drug can cause fetal harm when given to a pregnant woman. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, this drug can potentially be transmitted from the mother to the developing fetus.
-Verify the pregnancy status of females of reproductive potential prior to initiating this drug.
-Advise women of the potential risk to a fetus.
-Advise females of reproductive potential to use effective contraception during treatment with this drug and for 4 months after the last dose.

Animal studies suggest that blocking the PD-1/PD-L1 pathway may increase the risk of immune-related rejection and fetal death. Reproduction studies have not assessed the impact of the use of this drug on fetal development. The PD-1/PD-L1 pathway plays a crucial role in maintaining maternal immune tolerance during pregnancy. In murine pregnancy models, disrupting PD-L1 signaling increased fetal loss, indicating potential risks for higher abortion or stillbirth rates with use of this drug during pregnancy. Although there were no reported malformations, immune-mediated disorders occurred in mice lacking PD-1/PD-L1 signaling. Based on its mechanism, fetal exposure to this drug may increase the risk of immune-related disorders or may interfere with 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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Toripalimab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 4 months after the last dose.

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

Comments:
-No data is available regarding presence of this drug in human milk, the effects on the breastfed child or on milk production.
-Maternal immunoglobulin is known to be present in human milk.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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