KISUNLA

What it is

KISUNLA contains 350 mg of donanemab per 20 mL vial (17.5 mg/mL) . Donanemab is a recombinant monoclonal humanised antibody produced in Chinese Hamster Ovary cells with a molecular weight of 145 kDa . It is supplied as a concentrated solution for intravenous infusion, presented as a sterile, non-pyrogenic, preservative-free solution in a single-dose vial . Donanemab is an immunoglobulin gamma 1 monoclonal antibody directed against an insoluble, pyroglutamate N-terminal truncated form of amyloid beta present only in brain amyloid plaques . It binds to this target and aids plaque removal through microglial-mediated phagocytosis . KISUNLA is subject to additional monitoring in Australia .

Approved indications

— Mild Cognitive Impairment due to Alzheimer's disease in apolipoprotein E ε4 heterozygotes or non-carriers . — Mild Alzheimer's dementia (early symptomatic Alzheimer's disease) in apolipoprotein E ε4 heterozygotes or non-carriers . Beta amyloid evidence consistent with Alzheimer's disease should be confirmed using a validated test prior to initiating treatment .

Dosing overview

The recommended dose of donanemab is 350 mg for the first dose, 700 mg for the second dose, 1050 mg for the third dose, followed by 1400 mg every 4 weeks . KISUNLA must be diluted and is administered as an intravenous infusion over approximately 30 minutes every four weeks . Treatment should be maintained until amyloid plaques are cleared as confirmed using a validated method, up to a maximum of 18 months, or continued for up to 18 months if monitoring of amyloid plaque clearance is not possible .

Key safety warnings

Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities characterised as ARIA with oedema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H) . 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 . ARIA-E can cause focal neurologic deficits that can mimic ischaemic stroke, and thrombolytic treatment should be carefully considered in this population . KISUNLA is not indicated in apolipoprotein E ε4 homozygous patients . Patients who are ApoE ε4 homozygotes have a higher incidence of amyloid-related imaging abnormalities 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 . Infusion-related reactions, including anaphylaxis, have been observed with administration of KISUNLA, and these reactions may be severe or life-threatening and typically occur during infusion or within 30 minutes post infusion . Signs and symptoms of infusion-related reactions may include erythema, chills, nausea, vomiting, sweating, headache, chest tightness, dyspnoea, and changes in blood pressure .

Contraindications

Hypersensitivity to donanemab or to any of the excipients . Baseline MRI findings of prior intracerebral haemorrhage greater than 1 cm, more than 2 microhaemorrhages, superficial siderosis or vasogenic oedema (ARIA-E), which are suggestive of cerebral amyloid angiopathy . Severe white matter disease . Any finding that could prevent a satisfactory MRI evaluation for safety monitoring .

PBS listing

KISUNLA is not listed on the Pharmaceutical Benefits Scheme. The Pharmaceutical Benefits Advisory Committee recommended against listing in July 2025, noting that potential benefits are too small and uncertain to justify the burden of treatment, with high burden of treatment on patients and health system combined with risks and modest clinical impact .

Regulatory history

KISUNLA was first registered on the Australian Register of Therapeutic Goods on 21 May 2025 . The Pharmaceutical Benefits Advisory Committee considered the medicine in July 2025 and did not recommend it for PBS listing .