Donanemab
KISUNLA
What it isAnti-amyloid antibody targeting deposited plaque; early Alzheimer disease.
Why this oneDosing can stop once amyloid clears on PET, unlike open-ended alternatives.
What limits itARIA requires baseline and serial MRI, with extra caution in APOE4 carriers; infusion reactions can end treatment.
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Amyloid-related imaging abnormalities (ARIA-E edema, ARIA-H hemosiderin/microhemorrhage), which can be serious, life-threatening, or fatal; intracerebral hemorrhage >1 cm; higher ARIA risk in ApoE ε4 homozygotes — test ApoE ε4 status before starting.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Alzheimer's disease (initiate in mild cognitive impairment/mild dementia stage) | Adults | 350 mg IV infusion #1, then 700 mg #2, 1,050 mg #3 | 1,400 mg IV every 4 weeks (infusion #4 and beyond) | 1,400 mg q4w |
Renal Undefined
Hepatic Undefined
If an infusion is missed, resume q4w at the same dose as soon as possible
Instructions
- Confirm amyloid beta pathology before initiating
- Obtain baseline brain MRI before treatment and before 2nd, 3rd, 4th, and 7th infusions
- Dilute to 4-10 mg/mL in 0.9% NaCl; infuse IV over ~30 min every 4 weeks
- Observe ≥30 min post-infusion for infusion/hypersensitivity reactions
- Consider stopping when amyloid plaques reduced to minimal levels on PET; consider pre-medication (antihistamine/NSAID/corticosteroid) for subsequent infusions
- Interrupt/suspend dosing per ARIA severity and symptoms
Contraindications
- Known serious hypersensitivity to donanemab-azbt or excipients (reactions have included anaphylaxis)
Cautions
- ARIA — enhanced clinical vigilance during first 24 weeks; higher risk in ApoE ε4 homozygotes and with pretreatment microhemorrhages/superficial siderosis
- Additional caution with antithrombotic/thrombolytic agents (intracerebral hemorrhage risk)
- Hypersensitivity reactions including anaphylaxis and angioedema
- Infusion-related reactions
Adverse reactions
- ARIA-E
- ARIA-H microhemorrhage
- ARIA-H superficial siderosis
- Headache
- Infusion-related reactions
Pregnancy No adequate data; no animal studies conducted
Lactation No data on presence in human milk; monoclonal antibodies generally show low milk passage
NO BOXED WARNINGS
Principal riskARIA; APOE4 stratification and MRI monitoring
Classes and tags
Clinical profile
Mechanism of action: Donanemab ballicule
