Tislelizumab Pregnancy and Breastfeeding Warnings

Brand names: Tevimbra

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

Tislelizumab Pregnancy Warnings

Avoid during pregnancy.

AU TGA pregnancy category: D
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. Advise women to the potential risk to the fetus.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Females of childbearing potential should use effective contraception during treatment and for 4 months after the last dose.
-According to some authorities, this drug should not be used in women of childbearing potential not using effective contraception.

Animal studies with this drug have not been conducted, however, murine models have shown that blockade of the program death receptor ligand 1 (PD-L1) signaling can disrupt tolerance to the fetus increasing the risk of fetal loss and stillbirth. Based on its mechanism of action, fetal exposure to this drug may increase the risk of developing immune-mediated disorders or 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.

See references

Tislelizumab 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:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-This drug is a protein with a large molecular weight, the amount in milk is likely very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract, so absorption is probably minimal.

See references

Further information

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