Aldesleukin Pregnancy and Breastfeeding Warnings

Brand names: Proleukin

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Aldesleukin Pregnancy Warnings

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

US FDA pregnancy category: Not assigned.

Risk summary: This drug can cause fetal harm or loss when administered to a pregnant woman; it has been shown to be embryolethal and teratogenic in animal studies. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

Comments:
-Sexually active female and male patients should use effective contraception during treatment.
-This drug should not be administered to fertile persons of either gender who are not practicing effective contraception.

Animal studies have revealed evidence of embryotoxicity and embryolethality. There are no controlled data in human pregnancy.

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

Aldesleukin 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:
-Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during therapy.

See references

Further information

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

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