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Tebentafusp Pregnancy and Breastfeeding Warnings

Brand names: Kimmtrak

Medically reviewed by Drugs.com. Last updated on May 4, 2022.

Tebentafusp Pregnancy Warnings

Animal studies have not been reported. Molecules of similar molecular weight can cross the placenta leading to fetal exposure. 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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Based on mechanism of action, this drug may cause fetal harm when used during pregnancy; no data are available on use of this drug in pregnant women.

Comments:
-The patient should be apprised of the potential harm to the fetus.
-Before starting this drug, pregnancy status should be verified in patients of childbearing potential.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for at least 1 week after the last dose.

See references

Tebentafusp Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 1 week after the last dose.

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

Comments:
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in a breastfed child.

See references

References for pregnancy information

  1. Product Information. Kimmtrak (tebentafusp). Immunocore LLC. 2022.

References for breastfeeding information

  1. Product Information. Kimmtrak (tebentafusp). Immunocore LLC. 2022.

Further information

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