Aldesleukin Pregnancy and Breastfeeding Warnings

Aldesleukin is also known as: Proleukin

Aldesleukin Pregnancy Warnings

Aldesleukin has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality. Maternal toxicities were observed in pregnant rats given aldesleukin doses 2.1 to 36 times higher than the human dose during critical periods of organogenesis. No teratogenicity was observed besides the maternal toxicity. There are no data from controlled human pregnancy studies. Aldesleukin should only be given during pregnancy when benefit outweighs risk.

Aldesleukin Breastfeeding Warnings

The molecular weight of aldesleukin suggests that it will not be excreted into breast milk. The very short distribution and elimination half-lives may limit the amount reaching the embryo and fetus. Waiting four hours after a dose to breast-feed should limit the potential exposure to an infant even more.

There are no data on the excretion of aldesleukin into human milk. Because of the possibility that aldesleukin may be excreted into human milk and cause serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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