Tovorafenib Pregnancy and Breastfeeding Warnings
Brand names: Ojemda
Medically reviewed by Drugs.com. Last updated on Jun 6, 2024.
Tovorafenib Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned
Risk summary: Based on its mechanism of action, this drug may cause fetal harm. No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Negative pregnancy status should be verified in patients of childbearing potential before starting treatment.
-Pregnant women should be advised about the potential risk to a fetus.
-This drug may impair fertility in males and females.
-This drug can render hormonal contraceptives ineffective. Female patients of reproductive potential should use effective non-hormonal contraception during treatment and for 28 days after the last dose.
-Male patients with female partners of reproductive potential should use effective non-hormonal contraception during treatment and for 2 weeks after the last dose.
Animal studies have revealed evidence of embryolethality. In pregnant rats during organogenesis, embryolethality was observed at doses of 37.5 mg/kg/day or greater (about 0.8 times the human exposure at the recommended dose based on AUC). Based on findings in animals, the effects on male fertility were reversible, while the effects on female fertility were not reversible. 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.
Tovorafenib Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug and for 2 weeks after the last dose.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug can harm a nursing infant.
-The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2024) "Product Information. Ojemda (tovorafenib)." Day One Biopharmaceuticals, Inc.
References for breastfeeding information
- (2024) "Product Information. Ojemda (tovorafenib)." Day One Biopharmaceuticals, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.