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Idelalisib Pregnancy and Breastfeeding Warnings

Idelalisib is also known as: Zydelig

Medically reviewed on September 11, 2017

Idelalisib Pregnancy Warnings

This drug was associated with decreased fetal weights, external malformations, and skeletal variations in animal studies. 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.

Use is not recommended.

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

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.
-Patients should use contraception while taking this drug and for at least one month after the last dose.

Risk Summary: Based on findings in animal studies and the mechanism of action, this drug may cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration during organogenesis resulted in decreased fetal weight and congenital malformations at maternal exposures 12 times higher than recommended human dose.

Comments:
-A pregnancy exposure registry is available.
-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

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

Comments:
-A risk to the nursing infant cannot be excluded.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for at least one month after the last dose.

No information is available on the clinical use of this drug during breastfeeding. Because it is more than 84% bound to plasma proteins, the amount in milk is likely to be low. It is sometimes given in combination with rituximab, which may increase the risk to the infant.

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.

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