Welcome to the Lilly Neuroscience Health Portal. This site is intended to provide information on Lilly medicines and services for Health Care Professionals in Australia.
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This section of the website is for Healthcare Professionals only.
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
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 haemosiderin 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 Section 4.4 Special warnings and precautions for use, and Section 4.8 Adverse effects (Undesirable effects)). ARIA-E can cause focal neurologic deficits that can mimic ischaemic stroke. Thrombolytic treatment should be carefully considered in this population.
ApoE ε4 Genotype
KISUNLA is not indicated in apolipoprotein E ε4 (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 Section 4.4 Special warnings and precautions for use).
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 Section 4.4 Special warnings and precautions for use and Section 5.1 Pharmacodynamic properties, Clinical Trials).
PBS Information: Kisunla is not listed on the PBS.
Please review the approved Kisunla Product Information and Boxed Warning before prescribing, available at https://rss.medsinfo.com.au/ly/pi.cfm?product=lypkisun