Donanemab

KISUNLA

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Pronunciation: doe-NAN-e-mab (ki-SUN-la)

Donanemab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Donanemab ballicule

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.

Donanemab molecular structure (skeletal formula) — Molecular structure: Donanemab

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

Available strengths

inj 17.5 mg/mL

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

Cost

Donanemab (KISUNLA)

Strength		#/mo	generic $/unit	CostPlus
17.5 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Donanemab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNING

Amyloid-related imaging abnormalities

Principal riskARIA; APOE4 stratification and MRI monitoring

Classes and tags

Clinical profile

Therapeutic safety burden4 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityAmyloid-related edema and potentially fatal intracerebral hemorrhage

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