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Anti-Amyloid Immunotherapy (IgG1 — Targets Pyroglutamate-Modified Amyloid-β)

Donanemab (Anti-Amyloid Monoclonal Antibody)

Brand names: Kisunla

Donanemab is an anti-amyloid monoclonal antibody used in early symptomatic Alzheimer's disease to slow clinical progression by reducing cerebral amyloid plaque.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It is a monoclonal antibody that binds to deposited amyloid-beta plaque and promotes its clearance, lowering the cerebral amyloid burden.

Prescribing in practice

  • Amyloid-related imaging abnormalities (ARIA), comprising cerebral oedema and microhaemorrhage, are the key risk and require baseline and scheduled MRI surveillance, with caution in carriers of the ApoE e4 genotype.
  • Confirmation of amyloid pathology and exclusion of contraindications such as significant prior haemorrhage are needed before starting, with treatment given by infusion under specialist supervision.
  • Concurrent antithrombotic or anticoagulant therapy may increase the risk of haemorrhagic complications and should be carefully assessed.

Monitoring

Regular MRI monitoring for ARIA, alongside review for infusion reactions and cognitive response, is integral to treatment.

Counselling the patient

  • You will need regular brain scans to check for swelling or small bleeds.
  • Report any new headache, confusion, dizziness or visual changes promptly.
  • Treatment aims to slow progression rather than reverse the condition.

Evidence & guidelines

Phase 3 trial evidence shows donanemab reduces amyloid plaque and modestly slows clinical decline in early Alzheimer's disease.

Reference: Sims et al. NEJM 2023 (TRAILBLAZER-ALZ 2); FDA Prescribing Information Kisunla 2024; Alzheimer's Association 2024 guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.