Ensartinib Pregnancy and Breastfeeding Warnings

Brand names: Ensacove

Medically reviewed by Drugs.com. Last updated on Jun 30, 2025.

Ensartinib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action and findings from animal studies, this drug may cause fetal harm when administered to pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

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 1 week 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.

Animal studies have revealed evidence of adverse developmental outcomes. Administration of this drug to pregnant animals during the period of organogenesis at maternal doses approximately equivalent (and up to 6.4 times) the human exposure at the recommended dose of 225 mg/day based on AUC resulted in an increased incidence of fetal malformations, visceral variations, delayed ossification, decreased fetal weight, increased pre- and post-implantation loss, fewer live births, and maternal toxicity. 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.

See references

Ensartinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 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 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

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