Kisunla Warnings

Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterised as ARIA with oedema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur. Serious intracerebral haemorrhages, some of which have been fatal, have been observed in patients treated with this class of medications (see Precautions and Adverse Reactions). ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke. Thrombolytic treatment should be carefully considered in this population.
ApoE ε4 Genotype: KISUNLA is not indicated in apolipoprotein Eε4 (ApoE ε4) homozygous patients. Patients who are ApoE ε4 homozygotes (approximately 15% of Alzheimer's disease patients) treated with this class of medications, including KISUNLA, have a higher incidence of amyloid-related imaging abnormalities (ARIA) in the brain, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and non-carriers. Testing for ApoE ε4 status is required prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results (see Precautions).
Consider the benefit of KISUNLA for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with KISUNLA (see Precautions and Pharmacology: Pharmacodynamics: Clinical trials under Actions).