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donanemab

Kisunla · ATC code N06DX05

Key facts
Active substance
donanemab
Drug class
Antidementia agent
ATC code
N06DX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kisunla 350 mg concentrate for solution for infusion
Marketing authorisation holder
Eli Lilly Nederland B.V.
Information as of
2026-10-27

Key facts

Donanemab is a monoclonal antibody targeting amyloid plaques (Kisunla, concentrate for infusion). It is used in adults with early symptomatic Alzheimer's disease and confirmed amyloid pathology.

What it is used for

  • Adults with mild cognitive impairment or mild dementia due to Alzheimer's disease (early symptomatic Alzheimer's disease)
  • Only in ApoE ε4 heterozygotes or non-carriers with confirmed amyloid pathology

Dosing

  • Infusion every 4 weeks: 350 mg (first dose), 700 mg (second), 1,050 mg (third), then 1,400 mg every 4 weeks
  • Continue until amyloid plaques are cleared (e.g. at 6 or 12 months); maximum treatment duration 18 months
  • Before starting: ApoE ε4 testing and confirmation of amyloid pathology (e.g. PET or CSF)
  • Initiated by experienced physicians with MRI access; dose interruption or discontinuation for ARIA as set out in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Baseline MRI with prior intracerebral haemorrhage, more than 4 microhaemorrhages, superficial siderosis, vasogenic oedema or findings suggestive of cerebral amyloid angiopathy
  • Bleeding disorders not under adequate control; initiation during ongoing anticoagulant therapy
  • Severe white matter disease; poorly controlled hypertension
  • Conditions that do not allow MRI (e.g. claustrophobia, cardiac pacemaker)

Important warnings

  • Amyloid-related imaging abnormalities (ARIA-E with oedema, ARIA-H with microhaemorrhage/siderosis); intracerebral haemorrhages greater than 1 cm have occurred
  • Initiation only via a controlled access programme with central registration
  • Patients receive a patient card and educational material on ARIA
  • Infusion-related and hypersensitivity reactions, including anaphylaxis

Side effects

  • Most frequent: ARIA-E (20.6%), ARIA-H (27.6%), headache (14.6%)
  • Serious: serious ARIA-E (1.3%), serious ARIA-H (0.3%), serious hypersensitivity including infusion-related reactions (0.4%)
  • Anaphylactic reaction uncommon (0.4%)

Interactions

  • No interaction studies; no pharmacokinetic interactions expected
  • Caution with antithrombotics, as the risk of intracerebral haemorrhage may be increased

Pregnancy and breastfeeding

  • Pregnancy: no or limited data; as a precaution, use should preferably be avoided
  • Breast-feeding: a risk cannot be excluded in the first days after birth; afterwards consider only if clinically needed

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • KisunlaEli Lilly Nederland B.V. · EMEA/H/C/006024

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Kisunla
Liechtenstein
Kisunla
Norway
Kisunla

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Kisunla – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/kisunla-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N06DX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.