Telisotuzumab vedotin Pregnancy and Breastfeeding Warnings

Brand names: Emrelis

Medically reviewed by Drugs.com. Last updated on Jun 23, 2025.

Telisotuzumab vedotin Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered during pregnancy; no data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The monomethyl auristatin E (MMAE) component of this drug is genotoxic and affects actively dividing cells.
-The patient should be apprised of the potential harm to the fetus.
-Pregnancy status should be verified in patients of childbearing potential before starting this drug.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for 2 months after the last dose.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 4 months after the last dose.
-This drug may impair fertility in both males and females; in animal studies, the effect was reversible in females, while the reversibility in males is currently unknown.

Animal studies have not been reported with this drug; however, animal studies with MMAE have revealed evidence of fetal harm. In pregnant rats, 2 IV doses of MMAE (the small molecule component of this drug) during organogenesis caused embryofetal mortality and structural abnormalities (including protruding tongue, agnathia, malrotated limbs, gastroschisis) at a dose of 0.2 mg/kg (about 2 times the human AUC at the recommended dose). There are no controlled data in human pregnancy.

Based on animal studies with MMAE-containing antibody-drug conjugates, this drug may impair female fertility; the effect is reversible. Based on animal studies, this drug may impair male fertility; reversibility of this effect is unknown.

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

Telisotuzumab vedotin Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 month 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 breastfed child.
-There are no data on the presence of this drug or unconjugated monomethyl auristatin E in human milk or the effects of this drug on milk production.

See references

Further information

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