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Molecule

Lecanemab

Amyloid Beta-directed Antibody
Available on requestBiologicCold chainPsychiatry
Presentations
4
Brands
2
Manufacturers
1
Available from stock
0

Lecanemab is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. It is available as injection for intravenous and subcutaneous use. MedsAcross supplies Lecanemab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Amyloid Beta-directed Antibody, Amyloid Beta-directed Antibody Interactions
ATC classification
N06DX04 Lecanemab · Antidementia agent, subgroup N06DX
US FDA first approval
6 January 2023
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous, Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 12PYH0FTU9CAS 1260393-98-3DrugBank DB14580Q56274769

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

Source: US FDA prescribing information

How it works

Lecanemab-irmb is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. LEQEMBI reduces amyloid beta plaques, as evaluated in Study 1 and Study 2.

Source: US FDA prescribing information

Dosing overview

Confirm the presence of amyloid beta pathology prior to initiating treatment. Obtain a recent baseline brain MRI prior to initiating treatment. Obtain an MRI after 1, 2, 3, and 6 months of treatment. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms. Recommended starting dosage: Intravenous infusion: 10 mg/kg once every 2 weeks administered after dilution as an intravenous infusion over approximately one hour. Subcutaneous injection: 500 mg administered once a week using the LEQEMBI IQLIK autoinjector. After 18 months, continue treatment with the starting dosage or transition to an intravenous or subcutaneous maintenance dosage. Recommended maintenance dosage: Intravenous infusion: 10 mg/kg once every 4 weeks. Subcutaneous injection: 360 mg administered once a week using the LEQEMBI IQLIK autoinjector.

Source: US FDA prescribing information

Contraindications

LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (amyloid related imaging abnormalities): Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E ε4 homozygotes compared to heterozygotes and noncarriers. The risk of ARIA-E and ARIA-H is increased in patients with pretreatment microhemorrhages and/or superficial siderosis. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI scanning if indicated.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Amyloid Related Imaging Abnormalities Hypersensitivity Reactions Infusion-Related Reactions Most common adverse reactions (at approximately 10% and higher incidence compared to placebo): infusion-related reactions, amyloid related imaging abnormality-microhemorrhages, amyloid related imaging abnormality-edema/effusion, and headache. Additionally, injection-related reactions occurred in patients receiving subcutaneously administered LEQEMBI.

Source: US FDA prescribing information

Storage

Store LEQEMBI vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Subcutaneous Injection Store LEQEMBI IQLIK autoinjectors in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. If needed, the autoinjectors can be stored at room temperature up to 25°C (77°F) in the original carton for up to 14 days. Once the autoinjector has been stored at room temperature, do not return it to the refrigerator. Store in the original carton to protect from light. Diluted Solution For storage of the diluted infusion solution, see Dosage and Administration. Store in original carton to protect from light.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Lecanemab, sorted by availability.

MedicineManufacturerRegisterAvailability
Lecanemab Autoinjector 250 mg/1.25 mL injectionSubcutaneous Cold chainEisaiUS FDAAvailable on request
Lecanemab Autoinjector 360 mg/1.8 mL injectionSubcutaneous Cold chainEisaiUS FDAAvailable on request
Leqembi 200 mg/2 mL injectionIntravenous Cold chainEisaiUS FDAAvailable on request
Leqembi 500 mg/5 mL injectionIntravenous Cold chainEisaiUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 6 January 2023Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Lecanemab available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Lecanemab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Lecanemab have?

The catalogue lists 2 brand names for Lecanemab, including Lecanemab Autoinjector, Leqembi.

Is Lecanemab approved by the US FDA?

Yes. The US FDA first approved Lecanemab on 6 January 2023, according to Drugs@FDA.

Is Lecanemab authorised in the European Union?

Yes. Lecanemab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Lecanemab need cold chain shipping?

At least one listed presentation of Lecanemab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Lecanemab in?

Lecanemab is classified under ATC code N06DX04 (Lecanemab).

References

  1. LEQEMBI prescribing information (Eisai). U.S. National Library of Medicine, DailyMed. Retrieved 21 July 2026
  2. Leqembi: European public assessment report (EPAR). European Medicines Agency. Retrieved 5 August 2026

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