Ivosidenib Pregnancy and Breastfeeding Warnings

Brand names: Tibsovo

Medically reviewed by Drugs.com. Last updated on Aug 22, 2023.

Ivosidenib Pregnancy Warnings

Safety has not been established during pregnancy. The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data, this drug can cause fetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk of major birth defects and miscarriage.

Comments:
-Verify pregnancy status before initiating treatment with drug.
-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.
-Effective contraception is advised during therapy and for 1 month after the last dose.
-This drug may reduce systemic concentrations of hormonal contraceptives. Advice patients to concomitantly use alternative contraceptive methods like barrier contraceptives.

Animal studies have revealed evidence of fetal harm. After oral administration to pregnant rats during organogenesis, adverse embryofetal effects (including lower fetal weights, skeletal variations) were observed; these effects occurred at about 2 times the human exposure (at the recommended dose of 500 mg/day). This drug was maternally toxic at about 3.9 times the human exposure (at the recommended dose of 500 mg/day) in pregnant rabbits treated during organogenesis; spontaneous abortions, decreased fetal weights, skeletal variations, and visceral variations were observed. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Ivosidenib 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: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for adverse reactions in breastfed children.

This drug is 92% to 96% bound to plasma proteins, thus the amount in milk is likely to be low. However, because its half-life is about 93 hours, this drug may accumulate in the infant.

See references

Further information

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