Tislelizumab Pregnancy and Breastfeeding Warnings

Brand names: Tevimbra

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Tislelizumab Pregnancy Warnings

This drug should not be used during pregnancy or in patients of childbearing potential not using effective contraception unless the benefit outweighs the risk to the fetus.

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; no data are available on the use of this drug in pregnant women.

Comments:
-Human immunoglobulin G4 (IgG4) is known to cross the placental barrier; because this drug is an IgG4 variant, it may be transmitted from the mother to the developing fetus.
-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.
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-Patients of childbearing potential should be advised to use effective contraception (methods resulting in less than 1% pregnancy rates) during therapy and for at least 4 months after the last dose.

Animal studies have not been reported; however, based on its mechanism of actions, this drug can cause fetal harm. A central function of the programmed death receptor-1/ligand-1 (PD-1/PD-L1) pathway is preservation of pregnancy by maintaining maternal immune tolerance to the fetus. Blockade of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering this drug during pregnancy include increased rates of abortion/stillbirth. No malformations related to the blockade of PD-1 signaling were reported 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 may increase the risk of developing immune-mediated disorders or of altering the normal immune response. There are no controlled data in human pregnancy.

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.

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Tislelizumab Breastfeeding Warnings

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

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions.
-Antibodies (including immunoglobulin G4 [IgG4]) are excreted in human milk.
-According to some experts, waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.

Because this drug is a large protein molecule (molecular weight of 147 kilodaltons), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

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Further information

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

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