Taletrectinib Pregnancy and Breastfeeding Warnings

Brand names: Ibtrozi

Medically reviewed by Drugs.com. Last updated on Jul 8, 2025.

Taletrectinib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on literature reports in humans with congenital mutations leading to changes in tropomyosin receptor kinase (TRK) signaling, findings from animal studies, and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Limited data from case reports on use of this drug in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

Comments:
-Prior to therapy, verify the pregnancy status of females of reproductive potential.
-Women of childbearing potential and male patients with female partners of reproductive potential should be counseled to use effective contraception during treatment and for 3 weeks after the last dose.
-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.
-Male and female fertility may be compromised by this drug.

Animal studies have revealed evidence of fetal malformations and embryofetal death. Administration of this drug to pregnant animals during the period of organogenesis resulted in fetal abnormalities, maternal lethality, and increased pregnancy loss at exposures ranging from 0.04 to 1.3 times the human exposure based on AUC at the recommended dose. There are no controlled data in human pregnancy; however, published reports of individuals with congenital mutations in the TRK pathway proteins suggest that decreases in TRK-mediated signaling are correlated with obesity, developmental delays, cognitive impairment, insensitivity to pain, and anhidrosis.

Based on findings in animals, this drug may impair fertility in males and females. The effects on animal fertility were reversible.

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

Taletrectinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 3 weeks 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 a potential for serious adverse reactions.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.

See references

Further information

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

Medical Disclaimer