DONANEMAB-AZBT

Other

Brand names: Kisunla

Intravenous

Mechanism of Action

12.1 Mechanism of Action Donanemab-azbt is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. Donanemab-azbt reduces amyloid beta plaques, as evaluated in Study 1 [see Clinical Studies ( 14 )] .

Indications

the population in which treatment was initiated in the clinical trials. ( 1 )

Contraindications

• 5.2 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with KISUNLA
Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E ε4 (ApoE ε4) homozygotes compared to heterozygotes and noncarriers
The risk of ARIA-E and ARIA-H is increased in KISUNLA-treated patients with pretreatment microhemorrhages and/or superficial siderosis
ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur

Known Side Effects

6 documented side effects by frequency

Headache

1-10%

Dizziness

0.1-1%

Nausea

0.1-1%

Shortness of Breath

0.1-1%

High Blood Pressure

0.1-1%

Back Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous