Vorasidenib Pregnancy and Breastfeeding Warnings

Brand names: Voranigo

Medically reviewed by Drugs.com. Last updated on Oct 7, 2024.

Vorasidenib 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.
-Female patients of childbearing potential should be advised to use effective nonhormonal contraception during therapy and for 3 months after the last dose.
---This drug can cause some hormonal contraceptives to be ineffective.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 3 months after the last dose.

Animal studies have revealed evidence of embryofetal toxicity. After oral dosing to pregnant rats during organogenesis (at 10, 25, and 75 mg/kg/day [at least 45 times, about 97 times, and about 170 times, respectively, the human exposure based on AUC at the highest recommended dose]), embryofetal toxicity (higher incidence of early resorptions, visceral malformations of kidney and testes) was observed at the maternally toxic dose of 75 mg/kg/day; heart malformation was observed at 25 mg/kg/day, and dose-related delayed ossification of bones and short ribs (associated with decreased fetal body weights) was seen at 10 and 25 mg/kg/day without maternal toxicity and at 75 mg/kg/day. After oral dosing to pregnant rabbits during organogenesis (at 2, 6, and 18 mg/kg/day [at least 1.5 times the human exposure based on AUC at the highest recommended dose]), maternal toxicity occurred at all doses and higher incidence of late resorptions was observed at 18 mg/kg/day; decreased fetal weights and delayed ossification were seen at doses at least 6 mg/kg/day (at least 8 times the human exposure based on AUC at the highest recommended dose). There are no controlled data in human pregnancy.

Based on animal data, this drug may impair fertility in females and males of reproductive potential. The effects on fertility were not reversible in rats.

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

Vorasidenib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 2 months 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 adverse reactions in the breastfed child.

See references

Further information

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