BOXED WARNING Amyloid related imaging abnormalities (ARIA-E and ARIA-H); usually asymptomatic but serious/life-threatening events, including fatal, can occur. Serious intracerebral hemorrhages >1 cm have occurred. ApoE e4 homozygotes have higher ARIA incidence; test ApoE e4 status before initiating.
FDA dosing
Population
Start
Target
Max
Alzheimer's disease (initiate in mild cognitive impairment or mild dementia stage)
Adults
IV: 10 mg/kg every 2 weeks; or SC (IQLIK): 500 mg once weekly
After 18 months, continue starting dosage or transition to maintenance - IV 10 mg/kg every 4 weeks, or SC 360 mg once weekly
Renal Undefined (not studied; not expected to undergo renal elimination)
Hepatic Undefined (not studied; not expected to be metabolized by hepatic enzymes)
See label tables for switching routes and transitioning to maintenance dosing intervals
Instructions
Confirm amyloid beta pathology before initiating
Obtain baseline brain MRI, then MRI after 1, 2, 3, and 6 months; manage ARIA with dosing interruption per severity
IV infusion over ~1 hour after dilution in 250 mL 0.9% sodium chloride
SC injection into abdomen or upper thigh; rotate sites
Enhanced clinical vigilance for ARIA during first 14 weeks
Contraindications
Serious hypersensitivity to lecanemab-irmb or to any of the excipients (reactions have included angioedema and anaphylaxis)
Cautions
Amyloid related imaging abnormalities (ARIA-E/ARIA-H); increased risk in ApoE e4 homozygotes and in patients with pretreatment microhemorrhages/superficial siderosis
Intracerebral hemorrhage; caution with antithrombotic/thrombolytic therapy
Hypersensitivity reactions including anaphylaxis
Infusion-related reactions
Adverse reactions
Infusion-related reactions
ARIA-H (microhemorrhage/superficial siderosis)
ARIA-E (edema/effusion)
Headache
Injection-related reactions (SC)
Pregnancy No adequate human data; no animal studies conducted.
Lactation No data on presence in human milk; monoclonal antibodies generally show low passage into milk.
NO BOXED WARNINGS
Principal riskARIA edema and hemorrhage; highest risk in APOE4 homozygotes