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Ivosidenib Pregnancy and Breastfeeding Warnings

Ivosidenib is also known as: Tibsovo

Medically reviewed by Drugs.com. Last updated on May 10, 2019.

Ivosidenib Pregnancy Warnings

Animal studies at approximately 3.9 times the recommended human dose caused spontaneous abortions as well as decreased fetal weights, skeletal variations, and visceral variations. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on animal embryofetal toxicity studies, this drug may cause fetal harm when administered to a pregnant woman. There are no available data on its use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Comments:
-Based on animal studies, this drug may harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.

See references

Ivosidenib Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the presence of this drug or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
-Because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during therapy and for at least one month after the last dose.

See references

References for pregnancy information

  1. "Product Information. Tibsovo (ivosidenib)." Agios Pharmaceuticals, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Tibsovo (ivosidenib)." Agios Pharmaceuticals, Cambridge, MA.

Further information

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

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