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Idelalisib Pregnancy and Breastfeeding Warnings

Idelalisib is also known as: Zydelig

Medically reviewed on September 11, 2017.

Idelalisib Pregnancy Warnings

Idelalisib at doses of 75 mg/kg/day and 150 mg/kg/day (12 and 30 times human exposure, respectively) in pregnant rats was associated with decreased fetal weights, external malformations, and skeletal variations. There are no controlled data in human pregnancy.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

If used during pregnancy, or if the patient becomes pregnant while on this drug, the patient should be apprised of the potential hazard to the fetus.

US FDA pregnancy category: D

Comments: Use contraception while taking and for at least one month after taking the last dose of this drug.

See references

Idelalisib 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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Zydelig (idelalisib)." Gilead Sciences, Foster City, CA.

References for breastfeeding information

  1. "Product Information. Zydelig (idelalisib)." Gilead Sciences, Foster City, CA.

Further information

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