Effects on fertility: There are no data on the effect of donanemab on human fertility. No animal studies have been performed to test donanemab for potential fertility impairment.
Use in pregnancy - Pregnancy Category B2: There are no or limited data from the use of donanemab in pregnant women. Animal embryofetal development toxicity studies have not been conducted with donanemab. Donanemab is an IgG1-based antibody and may be transferred to the fetus during the third trimester.
KISUNLA is not recommended during pregnancy.
Use in lactation: Lactation studies have not been conducted in animals. Human immunoglobulin G (IgG) is known to be excreted in human milk; therefore, donanemab may be transmitted from the mother to the breastfed infant. The risks to a breast-fed infant are unknown.
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