Vimseltinib Pregnancy and Breastfeeding Warnings

Brand names: Romvimza

Medically reviewed by Drugs.com. Last updated on Apr 1, 2025.

Vimseltinib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-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.
-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 1 month after the last dose.
-Male patients with partners of childbearing potential should be advised to use effective contraception during therapy and for 1 month after the last dose.

Animal studies have revealed evidence of teratogenicity. After once-daily dosing to pregnant rats during organogenesis, structural abnormalities were observed at exposures about 3 times (skeletal variations) and about 23 times (cardiac malformations) the exposure at the recommended dose based on AUC. There are no controlled data in human pregnancy.

Based on animal data, this drug may impair fertility.

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

Vimseltinib 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: Unknown

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

See references

Further information

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

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