Donanemab (Anti-Amyloid Monoclonal Antibody)

NO UK SPC WAS AVAILABLE IN THIS BUNDLE - the dose above is taken from the US prescribing information for KISUNLA (donanemab-azbt, Eli Lilly, label date 2025-12-30) and must be verified against UK labelling/MHRA and NICE positioning before publication. PATIENT SELECTION: confirm the presence of amyloid beta pathology prior to initiating treatment. STOPPING: consider stopping dosing based on reduction of amyloid plaques to minimal levels on amyloid PET imaging - in the pivotal studies dosing was stopped based on a reduction of amyloid levels below predefined thresholds on PET. MISSED INFUSION: resume administration every 4 weeks at the same dose as soon as possible. MRI MONITORING FOR ARIA: obtain a recent baseline brain MRI prior to initiating treatment, and obtain an MRI prior to the 2nd, 3rd, 4th and 7th infusions; if a patient experiences symptoms suggestive of amyloid related imaging abnormalities (ARIA), perform clinical evaluation including MRI if indicated. DOSING INTERRUPTION FOR ARIA-E: asymptomatic patients with mild ARIA-E on MRI may continue at the current dose and schedule, but suspend dosing for moderate or severe ARIA-E on MRI; patients with mild clinical symptoms may continue based on clinical judgement if MRI severity is mild, and dosing should be suspended for moderate or severe clinical symptoms - suspend until MRI demonstrates radiographic resolution and symptoms resolve, with a follow-up MRI 2 to 4 months after initial identification considered, and resumption guided by clinical judgement. DOSING INTERRUPTION FOR ARIA-H: asymptomatic patients with mild ARIA-H may continue at the current dose and schedule, and dosing should be suspended for moderate or severe ARIA-H and for any symptomatic ARIA-H, until MRI demonstrates radiographic stabilisation and symptoms resolve; for severe ARIA-H, use clinical judgement when considering whether to continue or permanently discontinue. In patients who develop intracerebral haemorrhage greater than 1 cm in diameter during treatment, suspend dosing until MRI demonstrates radiographic stabilisation and symptoms resolve, then use clinical judgement on continuing or permanently discontinuing. PREPARATION: allow the vial to equilibrate to room temperature, inspect visually for particulate matter and discoloration (the solution is clear to opalescent, colourless to slightly yellow to slightly brown), use aseptic technique, and use only 0.9% sodium chloride injection for dilution. PRESENTATION: 350 mg/20 mL (17.5 mg/mL) single-dose vial. GERIATRIC USE (the relevant population): in Study 1 ages ranged from 59 to 86 years (mean 73; 90% aged 65 and over, 41% aged 75 and over) and in Study 2 from 59 to 85 years (mean 74; 93% aged 65 and over, 55% aged 75 and over); no overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. No age-based dose adjustment is stated. PAEDIATRIC: safety and effectiveness in paediatric patients have not been established - no paediatric dose is stated.