LECANEMAB AUTOINJECTOR lecanemab-irmb 200 mg/mL Injection, Solution, 2 syringes — NDC 62856-222-02 (Billing 62856-0222-02)
This is a package of 2 syringes of LECANEMAB AUTOINJECTOR lecanemab-irmb 200 mg/mL Injection, Solution from Eisai Inc., marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 62856-222-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 62856 labeler · 222 product · 02 package
- Package marketed since
- Jul 13, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0362856222105
- FDA record last changed
- Aug 13, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 2626147
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Amyloid Beta-directed Antibody class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats Alzheimer’s disease in people with mild cognitive impairment or mild dementia. It works by reducing amyloid plaques in the brain.
- It can be given as an IV infusion over about an hour, or as a weekly injection under the skin with the IQLIK autoinjector. Your prescriber decides which fits, and you can switch ro...
- The medicine can cause ARIA, brain swelling or small bleeds that often have no symptoms. MRIs before treatment and after 1, 2, 3 and 6 months help catch it early so your doctor can...
- Common ones are infusion or injection reactions and headache. Call right away for confusion, vision changes, dizziness, severe headache, trouble walking, seizures, or swelling of t...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62856-0222-02 You're viewing this Main listing | 2 SYRINGE, PLASTIC in 1 CARTON / 1.25 mL in 1 SYRINGE, PLASTIC | 2026-07-13 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lecanemab Autoinjector 200 mg/mL 62856-0220-01 | Eisai | 1 syringe | — | — | FDA listed | — |
| Lecanemab Autoinjector 200 mg/mLthis 62856-0222-02 | Eisai | 2 syringes | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Sep 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Aug 29, 2037 |
Is there a biosimilar for this drug?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Sep 5, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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42.13 mg / 1 mL
UNII F7LTH1E20Y
Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
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0.14 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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5.05 mg / 1 mL
UNII X573657P6P
Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
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0.50 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Eisai Inc. labeler code 62856
- LEQEMBI lecanemab 100 mg/mL Injection, Solution NDC 62856-212-01
- LEQEMBI lecanemab 100 mg/mL Injection, Solution NDC 62856-215-01
- LECANEMAB AUTOINJECTOR lecanemab-irmb 200 mg/mL Injection, Solution NDC 62856-220-01
- Aricept donepezil hydrochloride 5 mg Tablet, Film Coated NDC 62856-245-30
- Aricept donepezil hydrochloride 10 mg Tablet, Film Coated NDC 62856-246-30
- Aricept donepezil hydrochloride 23 mg Tablet, Film Coated NDC 62856-247-30
- Fycompa perampanel 2 mg Tablet NDC 62856-272-14
- Fycompa perampanel 4 mg Tablet NDC 62856-274-14
- Fycompa perampanel 6 mg Tablet NDC 62856-276-30
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events can occur.
ARIA can be fatal. Serious intracerebral hemorrhage s > 1 cm, some of which have been fatal, have been observed in patients treated with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )].
ApoE ε4 Homozygotes Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results.
Prescribers should inform patients that if genotype testing is not performed they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA [see Warnings and Precautions ( 5.1 )]. Consider the benefit of LEQEMBI for the treatment of Alzheimer’s disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with LEQEMBI [see Warnings and Precautions ( 5.1 ) and Clinical Studies ( 14 )]. WARNING: AMYLOID RELATED IMAGING ABNORMALITIES See full prescribing information for complete boxed warning.
Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause amyloid related imaging abnormalities (ARIA), as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). ARIA is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal.
Serious intracerebral hemorrhages > 1 cm have occurred in patients treated with this class of medications. ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke. ( 5.1 , 6.1 ) ApoE ε4 Homozygotes Patients treated with this class of medications, including LEQEMBI, who are ApoE ε4 homozygotes have a higher incidence of ARIA, including symptomatic and serious ARIA, compared to heterozygotes and noncarriers.
Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, the risk of ARIA across genotypes and implications of genetic testing results should be discussed with patients. ( 5.1 ) Consider the benefit for the treatment of Alzheimer’s disease and risk of ARIA when deciding to treat with LEQEMBI.
( 5.1 , 14 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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.
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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Confirm the presence of amyloid beta pathology prior to initiating treatment. ( 2.1 ) Obtain a recent baseline brain MRI prior to initiating treatment. ( 2.4 , 5.1 ) 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. ( 2.4 , 5.1 ) Recommended starting dosage: Intravenous infusion: 10 mg/kg once every 2 weeks administered after dilution as an intravenous infusion over approximately one hour. ( 2.2 , 2.5 ) Subcutaneous injection: 500 mg administered once a week using the LEQEMBI IQLIK autoinjector.
( 2.2 , 2.6 ). After 18 months, continue treatment with the starting dosage or transition to an intravenous or subcutaneous maintenance dosage. (2.2) Recommended maintenance dosage: Intravenous infusion: 10 mg/kg once every 4 weeks ( 2.2 , 2.5 ) Subcutaneous injection: 360 mg administered once a week using the LEQEMBI IQLIK autoinjector ( 2.2 , 2.6 ).
See Full Prescribing Information for preparation and administration instructions. ( 2.5 , 2.6 )
2.1Patient Selection Confirm the presence of amyloid beta pathology prior to initiating treatment [see Clinical Pharmacology ( 12.1 )] .
2.2Recommended Dosage Initiate LEQEMBI using a starting dosage regimen (see Table 1 ). After 18 months, the starting dosage regimen may be continued or a transition to a maintenance dosage regimen may be considered (see Table 2 ). Both the starting and maintenance dosage regimens can be administered by either intravenous infusion or subcutaneous injection.
The route of administration can be switched. When switching the route of administration and simultaneously transitioning from the starting dosage regimen to the maintenance dosage regimen, see Table 2. When switching the route of administration during the starting dosage regimen or during the maintenance dosage regimen, see Dosage and Administration ( 2.3 ).
Table 1: Starting Dosage Regimen Route of Administration Dose Frequency Infusion Rate (if i ntravenous) Intravenous (LEQEMBI) 10 mg/kg Once every 2 weeks Over approximately one hour Subcutaneous (LEQEMBI IQLIK) 500 mg (two 250 mg injections) Once every week ------------------------ Table 2: Maintenance Dosage Regimen Route of Administration Dose Frequency Infusion Rate (if intravenous) Time Interval Between Last Starting Dose and First Maintenance Dose Intravenous (LEQEMBI) 10 mg/kg Once every 4 weeks Over approximately one hour If previously on intravenous starting dosage regimen: 2 weeks If previously on subcutaneous starting dosage regimen: minimum of 2 weeks, but no more than 3 weeks Subcutaneous (LEQEMBI IQLIK) 360 mg Once every week — 1 week (regardless of starting dosage regimen) For intravenous infusion, use LEQEMBI vials.
LEQEMBI vials must be diluted before administration [see Dosage and Administration ( 2.5 )]. For subcutaneous administration, use LEQEMBI IQLIK [see Dosage and Administration ( 2.6 )].
2.3Switching Routes of Administration During the Starting Dosage Regimen or During the Maintenance Dosage Regimen During the starting dosage regimen and maintenance dosage regimen, the route of administration (intravenous with LEQEMBI vials or subcutaneous with LEQEMBI IQLIK) may be switched as described below. Thereafter follow the dosing schedule for the new route of administration. Switching Routes of Administration During the Starting Dosage Regimen • To switch from the intravenous to subcutaneous route of administration, administer the first subcutaneous dose 1 week after the last intravenous dose. • To switch from the subcutaneous to the intravenous route of administration, administer the first intravenous dose a minimum of 2 weeks, but no more than 3 weeks, after the last subcutaneous dose.
Switching Routes of Administration During the Maintenance Dosage Regimen • To switch from the intravenous to subcutaneous route of administration, administer the first subcutaneous dose 1 week af… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lecanemab-irmb is a clear to very opalescent, colorless to pale yellow solution, available as: Intravenous Infusion Injection: 500 mg/5 mL (100 mg/mL) in a single-dose vial Injection: 200 mg/2 mL (100 mg/mL) in a single-dose vial Subcutaneous Injection Injection: 250 mg/1.25 mL (200 mg/mL) in a single-dose prefilled LEQEMBI IQLIK ® autoinjector Injection: 360 mg/1.8 mL (200 mg/mL) in a single-dose prefilled LEQEMBI IQLIK ® autoinjector Intravenous Infusion Injection: 500 mg/5 mL (100 mg/mL) in a single-dose vial ( 3 ) Injection: 200 mg/2 mL (100 mg/mL) in a single-dose vial ( 3 ) Subcutaneous Injection Injection: 250 mg/1.25 mL (200 mg/mL) in a single-dose prefilled LEQEMBI IQLIK ® autoinjector ( 3 ) Injection: 360 mg/1.8 mL (200 mg/mL) in a single-dose prefilled LEQEMBI IQLIK ® autoinjector ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis [see Warnings and Precautions ( 5.2 )] . LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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. ( 2.4 , 5.1 ) Infusion-Related Reactions: The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered as clinically indicated. Consider pre-medication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids.
( 5.3 )
5.1Amyloid 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), which can be observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer’s disease, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy, such as pretreatment microhemorrhage or superficial siderosis.
ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E. ARIA-H of any cause and ARIA-E can occur together. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur.
ARIA can be fatal. When present, reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur.
Symptoms associated with ARIA usually resolve over time. In addition to ARIA, intracerebral hemorrhages greater than 1 cm in diameter have occurred in patients treated with LEQEMBI. Consider the benefit of LEQEMBI for the treatment of Alzheimer’s disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with LEQEMBI.
Incidence of ARIA Symptomatic ARIA occurred in 3% (29/898) of patients treated with LEQEMBI in Study 2 [see Clinical Studies ( 14 )]. Serious symptoms associated with ARIA were reported in 0.7% (6/898) of patients treated with LEQEMBI. Clinical symptoms associated with ARIA resolved in 79% (23/29) of patients during the period of observation.
Similar findings were observed in Study 1. Including asymptomatic radiographic events, ARIA was observed in 21% (191/898) of patients treated with LEQEMBI, compared to 9% (84/897) of patients on placebo in Study 2. In Study 2, ARIA-E was observed in 13% (113/898) of patients treated with LEQEMBI, compared to 2% (15/897) of patients on placebo.
ARIA-H was observed in 17% (152/898) of patients treated with LEQEMBI, compared to 9% (80/897) of patients on placebo. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for LEQEMBI compared to placebo. Incidence of Intracerebral Hemorrhage Intracerebral hemorrhage greater than 1 cm in diameter was reported in 0.7% (6/898) of patients in Study 2 after treatment with LEQEMBI, compared to 0.1% (1/897) on placebo.
Fatal events of intracerebral hemorrhage in patients taking LEQEMBI have been observed. Risk Factors for ARIA and Intracerebral Hemorrhage ApoE ε4 Carrier Status The risk of ARIA, including symptomatic and serious ARIA, is increased in apolipoprotein E ε4 (ApoE ε4) homozygotes. Approximately 15% of Alzheimer’s disease patients are ApoE ε4 homozygotes.
In Study 2, 16% (141/898) of patients in the LEQ… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Amyloid Related Imaging Abnormalities [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials with Intravenous Administration The safety of LEQEMBI has been evaluated in 2090 patients who received at least one dose of LEQEMBI by intravenous infusion. In Studies 1 and 2 in patients with Alzheimer’s disease, 1059 patients received LEQEMBI 10 mg/kg every two weeks by intravenous infusion [see Clinical Studies ( 14 )] .
Of these 1059 patients, 50% were female, 79% were White, 15% were Asian, 12% were of Hispanic or Latino ethnicity, and 2% were Black. The mean age at study entry was 72 years (range from 50 to 90 years). In the combined double-blind, placebo-controlled period and long-term extension period of Studies 1 and 2, 1604 patients received LEQEMBI for at least 6 months, 1261 patients for at least 12 months, and 965 patients for 18 months.
In the double-blind, placebo-controlled period in Study 1, patients stopped study treatment because of an adverse reaction in 15% of patients treated with LEQEMBI, compared to 6% patients on placebo; in Study 2, patients stopped study treatment because of an adverse reaction in 7% of patients treated with LEQEMBI, compared to 3% patients on placebo. In Study 1, the most common adverse reaction leading to discontinuation of LEQEMBI was infusion-related reactions that led to discontinuation in 2% (4/161) of patients treated with LEQEMBI, compared to 1% (2/245) of patients on placebo.
In Study 2, the most common adverse reaction leading to discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to discontinuation in 2% (15/898) of patients treated with LEQEMBI, compared to <1% (1/897) of patients on placebo. Table 6 shows adverse reactions that were reported in at least 5% of patients treated with LEQEMBI and at least 2% more frequently than in patients on placebo in Study 1. Table 6: Adverse Reactions Reported in at Least 5% of Patients Treated with LEQEMBI 10 mg/kg Every Two Weeks and at least 2% Higher than Placebo in Study 1 Adverse Reaction LEQEMBI 10 mg/kg Every Two Weeks N= 161 % Placebo N= 245 % Infusion-related reactions 20 3 Headache 14 10 ARIA-E 10 1 Cough 9 5 Diarrhea 8 5 Table 7 shows adverse reactions that were reported in at least 5% of patients treated with LEQEMBI and at least 2% more frequently than in patients on placebo in Study 2.
Table 7: Adverse Reactions Reported in at Least 5% of Patients Treated with LEQEMBI 10 mg/kg Every Two Weeks and at least 2% Higher than Placebo in Study 2 Adverse Reaction LEQEMBI 10 mg/kg Every Two Weeks N= 898 % Placebo N= 897 % Infusion-related reactions 26 7 ARIA-H 14 8 ARIA-E 13 2 Headache 11 8 Superficial siderosis of central nervous system 6 3 Rash 1 6 4 Nausea/Vomiting 6 4 1 Rash includes acne, erythema, infusion site rash, injection site rash, rash, rash erythematous, rash pruritic, skin reactions, and urticaria.
Less Common Adverse Reactions Atrial fibrillation occurred in 3% of patients treated with LEQEMBI, compare… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate data on LEQEMBI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal studies have been conducted to assess the potential reproductive or developmental toxicity of LEQEMBI. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
8.2Lactation Risk Summary There are no data on the presence of lecanemab-irmb in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Published data from other monoclonal antibodies generally indicate low passage of monoclonal antibodies into human milk and limited systemic exposure in the breastfed infant. The effects of this limited exposure are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEQEMBI and any potential adverse effects on the breastfed infant from LEQEMBI or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of LEQEMBI in pediatric patients have not been established.
8.5Geriatric Use In Studies 1 and 2, the age of patients exposed to LEQEMBI 10 mg/kg every two weeks (n=1059) ranged from 50 to 90 years, with a mean age of 72 years; 81% were 65 years and older, and 39% were 75 years and older. No overall differences in safety or effectiveness of LEQEMBI have been observed between patients 65 years of age and older and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate data on LEQEMBI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal studies have been conducted to assess the potential reproductive or developmental toxicity of LEQEMBI. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of LEQEMBI in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In Studies 1 and 2, the age of patients exposed to LEQEMBI 10 mg/kg every two weeks (n=1059) ranged from 50 to 90 years, with a mean age of 72 years; 81% were 65 years and older, and 39% were 75 years and older. No overall differences in safety or effectiveness of LEQEMBI have been observed between patients 65 years of age and older and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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 [see Clinical Studies ( 14 )] .
12.2Pharmacodynamics Effect of LEQEMBI on Amyloid Beta Pathology The effect of LEQEMBI on amyloid beta plaque levels in the brain was evaluated using Positron Emission Tomography (PET) imaging. The PET signal was quantified using both the standard uptake value ratio (SUVR) and Centiloid scale to estimate levels of amyloid beta plaque in composites of brain areas expected to be widely affected by Alzheimer’s disease pathology (frontal, parietal, lateral temporal, sensorimotor, and anterior and posterior cingulate cortices), compared to a brain region expected to be spared of such pathology (cerebellum).
LEQEMBI reduced amyloid beta plaque in a dose- and time-dependent manner in the dose-ranging study (Study 1) and in a time-dependent manner in single-dosing regimen study (Study 2) compared to placebo [see Clinical Studies ( 14 )] . In Study 1, treatment with LEQEMBI 10 mg/kg every two weeks reduced amyloid beta plaque levels in the brain, producing reductions in PET SUVR compared to placebo at both Weeks 53 and 79 ( P <0.0001). The magnitude of the reduction was time- and dose-dependent.
During an off-treatment period in Study 1 (range from 9 to 59 months; mean of 24 months), SUVR and Centiloid values began to increase with a mean rate of increase of
2.6Centiloids/year, however, treatment difference relative to placebo at the end of the double-blind, placebo-controlled period in Study 1 was maintained. In Study 2, treatment with LEQEMBI 10 mg/kg every two weeks reduced amyloid beta plaque levels in the brain, producing reductions compared to placebo starting at Week 13 and continuing through Week 79 ( P <0.0001). After Week 79 of treatment with LEQEMBI 10 mg/kg every two weeks, 67% of patients had amyloid levels less than 30 Centiloids as measured by PET.
Reduction of amyloid to levels less than 30 Centiloids was inversely related to amyloid PET levels at baseline. The percentage of patients achieving amyloid levels less than 30 Centiloids after continuous treatment with LEQEMBI 10 mg/kg every two weeks is predicted to increase over time. Based on exposure-response modeling, initiation of therapy with either lecanemab-irmb by intravenous administration (10 mg/kg every two weeks) or subcutaneous administration (500 mg once weekly) is predicted to have similar reduction of amyloid beta plaque levels.
It is predicted that, after Week 79 of treatment with LEQEMBI intravenous infusion of 10 mg/kg every 2 weeks, transitioning to a dosing regimen of either LEQEMBI intravenous infusion of 10 mg/kg every 4 weeks or LEQEMBI subcutaneous injection of 360 mg once a week will also continue the reduction in amyloid beta plaque levels. Based on exposure-response modeling, the intravenous (10 mg/kg every 4 weeks) and subcutaneous (360 mg once weekly) maintenance dosing regimens of lecanemab-irmb are predicted to have similar reduction of amyloid beta plaque levels.
An increase in plasma Aβ42/40 ratio (Table 8) and CSF Aβ[1-42] was observed with LEQEMBI 10 mg/kg every two weeks dosing compared to placebo. Exposure-response modeling predicts that, after Week 79 of treatment with LEQEMBI intravenous infusion of 10 mg/kg every 2 weeks, transitioning to a dosing regimen of either LEQEMBI intravenous infusion of 10 mg/kg every 4 weeks or LEQEMBI subcutaneous injection of 360 mg once a week will maintain increases in the plasma Aβ42/40 ratio. Effect of LEQEMBI on Tau Pathophysiology A reduction in plasma p-tau181 (Table 8), CSF p-tau181, and CSF t-tau was observed with LEQEMBI 10 mg/kg every two weeks compared to placebo.
Based… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 [see Clinical Studies ( 14 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied LEQEMBI single-dose vials and LEQEMBI IQLIK single-dose prefilled autoinjectors contain lecanemab-irmb as a sterile, preservative-free, clear to very opalescent, and colorless to pale yellow solution, available as described below. Intravenous Infusion Each LEQEMBI glass vial is closed with a stopper and flip cap and is available as follows: Strength Pack Size NDC Injection: 500 mg/5 mL (100 mg/mL) Carton of 1 single-dose vial 62856-215-01 Injection: 200 mg/2 mL (100 mg/mL) Carton of 1 single-dose vial 62856-212-01 Subcutaneous Injection Each LEQEMBI IQLIK prefilled autoinjector consists of a 2.25 mL syringe with a fixed 29-gauge ½-inch needle with needle guard and is available as follows: Strength Pack Size NDC Injection: 250 mg/1.25 mL (200 mg/mL) Carton of 2 single-dose prefilled autoinjectors 62856-222-02 Injection: 360 mg/1.8 mL (200 mg/mL) Carton of 1 single-dose prefilled autoinjector 62856-220-01 LEQEMBI IQLIK is not made with natural rubber latex.
16.2Storage and Handling Intravenous Infusion Unopened Vial Store LEQEMBI vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Store in the original carton to protect from light. Do not freeze or shake.
Diluted Solution For storage of the diluted infusion solution, see Dosage and Administration ( 2.5 ) . Subcutaneous Injection Store LEQEMBI IQLIK autoinjectors in a refrigerator at 2°C to 8°C (36°F to 46°F). Store in original carton to protect from light.
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.
Discard the autoinjector(s) if these conditions are exceeded.
16.1How Supplied LEQEMBI single-dose vials and LEQEMBI IQLIK single-dose prefilled autoinjectors contain lecanemab-irmb as a sterile, preservative-free, clear to very opalescent, and colorless to pale yellow solution, available as described below. Intravenous Infusion Each LEQEMBI glass vial is closed with a stopper and flip cap and is available as follows: Strength Pack Size NDC Injection: 500 mg/5 mL (100 mg/mL) Carton of 1 single-dose vial 62856-215-01 Injection: 200 mg/2 mL (100 mg/mL) Carton of 1 single-dose vial 62856-212-01 Subcutaneous Injection Each LEQEMBI IQLIK prefilled autoinjector consists of a 2.25 mL syringe with a fixed 29-gauge ½-inch needle with needle guard and is available as follows: Strength Pack Size NDC Injection: 250 mg/1.25 mL (200 mg/mL) Carton of 2 single-dose prefilled autoinjectors 62856-222-02 Injection: 360 mg/1.8 mL (200 mg/mL) Carton of 1 single-dose prefilled autoinjector 62856-220-01 LEQEMBI IQLIK is not made with natural rubber latex.
📦 Storage and Handling ▾
16.2Storage and Handling Intravenous Infusion Unopened Vial Store LEQEMBI vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Store in the original carton to protect from light. Do not freeze or shake.
Diluted Solution For storage of the diluted infusion solution, see Dosage and Administration ( 2.5 ) . Subcutaneous Injection Store LEQEMBI IQLIK autoinjectors in a refrigerator at 2°C to 8°C (36°F to 46°F). Store in original carton to protect from light.
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.
Discard the autoinjector(s) if these conditions are exceeded.
📋 Description ▾
11 DESCRIPTION Lecanemab-irmb is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, and is expressed in a Chinese hamster ovary cell line. Lecanemab-irmb has an approximate molecular weight of 150 kDa. LEQEMBI Injection for Intravenous Use LEQEMBI (lecanemab-irmb) injection is a sterile, preservative-free, clear to very opalescent and colorless to pale yellow solution for intravenous infusion after dilution.
LEQEMBI contains lecanemab-irmb at a concentration of 100 mg/mL in either a 500 mg/5 mL or 200 mg/2 mL single-dose vial. Each mL of solution contains 100 mg of lecanemab-irmb and arginine hydrochloride (42.13 mg), histidine (0.18 mg), histidine hydrochloride monohydrate (4.99 mg), polysorbate 80 (0.50 mg), and Water for Injection at an approximate pH of 5.0. LEQEMBI IQLIK Injection for Subcutaneous Use LEQEMBI IQLIK (lecanemab-irmb) injection is a sterile, preservative-free, clear to very opalescent, colorless to pale yellow solution for subcutaneous use.
LEQEMBI IQLIK contains lecanemab-irmb at a concentration of 200 mg/mL in either a 360 mg/1.8 mL or 250 mg/1.25 mL single-dose prefilled autoinjector with a 29-gauge fixed ½-inch needle. Each 360 mg/1.8 mL LEQEMBI IQLIK autoinjector contains 360 mg of lecanemab-irmb formulated in: arginine hydrochloride (75.83 mg), histidine (0.25 mg), histidine hydrochloride monohydrate (9.09 mg), polysorbate 80 (0.90 mg), and Water for Injection, USP. Each 250 mg/1.25 mL LEQEMBI IQLIK autoinjector contains 250 mg of lecanemab-irmb formulated in: arginine hydrochloride (52.66 mg), histidine (0.18 mg), histidine hydrochloride monohydrate (6.31 mg), polysorbate 80 (0.63 mg), and Water for Injection, USP.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Amyloid Related Imaging Abnormalities Inform patients that LEQEMBI may cause Amyloid Related Imaging Abnormalities or “ARIA”. ARIA most commonly presents as a temporary swelling in areas of the brain that usually resolves over time.
Some people may also have small spots of bleeding in or on the surface of the brain. Inform patients that most people with swelling in areas of the brain do not experience symptoms; however, some people may experience symptoms such as headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure. Instruct patients to notify their healthcare provider immediately if these symptoms occur.
Clinical evaluation should be performed, and an MRI may be considered. Inform patients that serious symptoms of ARIA may occur and that ARIA can be fatal. Inform patients that events of intracerebral hemorrhage greater than 1 cm in diameter have been reported infrequently in patients taking LEQEMBI, and that the use of antithrombotic or thrombolytic medications while taking LEQEMBI may increase the risk of bleeding in the brain.
Notify patients that their healthcare provider will perform MRI scans to monitor for ARIA [see Warnings and Precautions ( 5.1 )] . Inform patients that although ARIA can occur in any patient treated with LEQEMBI, there is an increased risk in patients who are ApoE ε4 homozygotes and that testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results.
Inform patients that if testing is not performed, it cannot be determined if they are ApoE ε4 homozygotes and at a higher risk for ARIA. Inform patients that some symptoms of ARIA-E can mimic ischemic stroke and that their healthcare providers may need to perform additional testing to determine how to treat those symptoms in patients taking LEQEMBI. Advise patients to carry information that they are being treated with LEQEMBI.
Patient Registry Providers should encourage patients to participate in real world data collection (e.g., registries) to help further the understanding of Alzheimer’s disease and the impact of Alzheimer’s disease treatments. Providers and patients can contact Eisai at 888-274-2378 for a list of currently enrolling programs [see Warnings and Precautions ( 5.1 )] . Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including angioedema and anaphylaxis have occurred in patients who were treated with LEQEMBI.
Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . Infusion-Related Reactions For patients receiving LEQEMBI via intravenous infusion, advise them of the potential risk of infusion-related reactions, which can include flu-like symptoms, nausea, vomiting, and changes in blood pressure. Advise patients that most infusion-related reactions occur with the first infusion but may occur with any of the infusions during treatment.
Advise patients that symptoms can occur during infusion or after they leave the infusion center and to contact their healthcare provider if infusion-related reactions occur [see Warnings and Precautions ( 5.3 )] . Injection-Related Reactions For patients receiving LEQEMBI IQLIK subcutaneous injection, advise them of the potential risks of injection reactions, which may present as erythema, induration, swelling, heat, rash, pain, itching, ecchymosis and hematoma at the injection site, but may also present with symptoms such as headache, fever, chills and fatigue.
Instruct patients to contact their healthcare provider if injection-related reactions occur [see Adverse Reactions ( 6.1 )]. Administration Instruc… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
MEDICATION GUIDE LEQEMBI ® (leh-kem’-bee) (lecanemab-irmb) injection, for intravenous or subcutaneous use What is the most important information I should know about LEQEMBI? LEQEMBI can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a side effect that does not usually cause any symptoms but serious symptoms can occur.
ARIA can be fatal. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur.
Most people who develop ARIA do not get symptoms; however, some people may have symptoms, such as: ○ headache ○ vision changes ○ seizures ○ confusion ○ nausea ○ difficulty speaking ○ dizziness ○ difficulty walking ○ muscle weakness Some people have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at a higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving LEQEMBI.
Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with LEQEMBI to check you for ARIA. You should carry information that you are receiving LEQEMBI which can cause ARIA and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries. For more information, call Eisai at 888-274-2378.
What is LEQEMBI ? LEQEMBI is a prescription medicine used to treat people with Alzheimer’s disease. It is not known if LEQEMBI is safe and effective in children.
Do not receive LEQEMBI if you: have serious allergic reactions to lecanemab-irmb or to any of the ingredients. See the end of this Medication Guide for a complete list of ingredients in LEQEMBI or LEQEMBI IQLIK. Before receiving LEQEMBI , tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.
It is not known if LEQEMBI will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with LEQEMBI. are breastfeeding or plan to breastfeed. It is not known if lecanemab-irmb (the active ingredient in LEQEMBI) passes into your breast milk.
Talk to your healthcare provider about the best way to feed your baby while receiving LEQEMBI. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
Ask your healthcare provider for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How will I receive LEQEMBI ? When given in a vein (intravenously) LEQEMBI is given by a healthcare provider through a needle placed in your vein (intravenous (IV) infusion) in your arm. Your healthcare provider will tell you how often you should receive LEQEMBI.
Each infusion will last about 1 hour. If you miss an infusion of LEQEMBI, you should receive your next dose as soon as possible. When given under the skin (subcutaneously) Read the detailed Instructions for Use that comes with your LEQEMBI IQLIK for information about the right way to prepare and give your LEQEMBI IQLIK injections at home.
After at least 2 consecutive doses of LEQEMBI IQLIK are given under the direct guidance of your healthcare p… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Steady-state concentrations of lecanemab-irmb were reached after 6 weeks of 10 mg/kg administered every 2 weeks and systemic accumulation was 1.4-fold. The peak concentration (C max ) and area under the plasma concentration versus time curve (AUC) of lecanemab-irmb increased dose proportionally in the dose range of 0.3 to 15 mg/kg following single dose. The estimated mean steady-state concentrations of lecanemab-irmb following 10 mg/kg biweekly intravenous infusion, 10 mg/kg monthly intravenous infusion, 500 mg weekly subcutaneous administration by autoinjector, and 360 mg weekly subcutaneous administration by autoinjector are provided in Table 9.
Using population pharmacokinetic modeling and simulation, initiation of therapy with the intravenous dosing regimen (10 mg/kg once every 2 weeks) or subcutaneous dosing regimen (500 mg once weekly) as well as maintenance of therapy with intravenous dosing regimen (10 mg/kg once every 4 weeks) or subcutaneous dosing regimen (360 mg once weekly) were predicted to have similar pharmacokinetic exposures. Table 9: Estimated Systemic Exposure of Lecanemab-irmb at Steady State in Patients with Alzheimer’s Disease* C av g ,ss (mcg/mL) Mean (CV%) Intravenous infusion 10 mg/kg every two weeks 156 (37.7) Intravenous infusion 10 mg/kg every four weeks 78.1 (37.7) Subcutaneous injection 500 mg weekly 164 (45.3) Subcutaneous injection 360 mg weekly 83.1 (58.8) *Based on simulations in 1000 virtual patients Absorption The absolute bioavailability of lecanemab-irmb was approximately 77.5% and 53%, respectively, following subcutaneous administration of 500 mg and 360 mg by autoinjector.
The bioavailability was not affected by the injection site (abdomen, upper thigh, or back of the upper arm). Distribution The mean value (95% CI) for central volume of distribution at steady state is 3.24 (3.18-3.30) L. Elimination Lecanemab-irmb is degraded by proteolytic enzymes in the same manner as endogenous IgGs.
The clearance of lecanemab-irmb (95% CI) is 0.370 (0.353-0.384) L/day. The terminal half-life is 5 to 7 days. Specific Populations Sex, body weight, and albumin were found to impact exposure to lecanemab-irmb.
However, none of these covariates were found to be clinically significant. Patients with Renal or Hepatic Impairment No clinical studies were conducted to evaluate the pharmacokinetics of lecanemab-irmb in patients with renal or hepatic impairment. Lecanemab-irmb is degraded by proteolytic enzymes and is not expected to undergo renal elimination or metabolism by hepatic enzymes.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Effect of LEQEMBI on Amyloid Beta Pathology The effect of LEQEMBI on amyloid beta plaque levels in the brain was evaluated using Positron Emission Tomography (PET) imaging. The PET signal was quantified using both the standard uptake value ratio (SUVR) and Centiloid scale to estimate levels of amyloid beta plaque in composites of brain areas expected to be widely affected by Alzheimer’s disease pathology (frontal, parietal, lateral temporal, sensorimotor, and anterior and posterior cingulate cortices), compared to a brain region expected to be spared of such pathology (cerebellum).
LEQEMBI reduced amyloid beta plaque in a dose- and time-dependent manner in the dose-ranging study (Study 1) and in a time-dependent manner in single-dosing regimen study (Study 2) compared to placebo [see Clinical Studies ( 14 )] . In Study 1, treatment with LEQEMBI 10 mg/kg every two weeks reduced amyloid beta plaque levels in the brain, producing reductions in PET SUVR compared to placebo at both Weeks 53 and 79 ( P <0.0001). The magnitude of the reduction was time- and dose-dependent.
During an off-treatment period in Study 1 (range from 9 to 59 months; mean of 24 months), SUVR and Centiloid values began to increase with a mean rate of increase of
2.6Centiloids/year, however, treatment difference relative to placebo at the end of the double-blind, placebo-controlled period in Study 1 was maintained. In Study 2, treatment with LEQEMBI 10 mg/kg every two weeks reduced amyloid beta plaque levels in the brain, producing reductions compared to placebo starting at Week 13 and continuing through Week 79 ( P <0.0001). After Week 79 of treatment with LEQEMBI 10 mg/kg every two weeks, 67% of patients had amyloid levels less than 30 Centiloids as measured by PET.
Reduction of amyloid to levels less than 30 Centiloids was inversely related to amyloid PET levels at baseline. The percentage of patients achieving amyloid levels less than 30 Centiloids after continuous treatment with LEQEMBI 10 mg/kg every two weeks is predicted to increase over time. Based on exposure-response modeling, initiation of therapy with either lecanemab-irmb by intravenous administration (10 mg/kg every two weeks) or subcutaneous administration (500 mg once weekly) is predicted to have similar reduction of amyloid beta plaque levels.
It is predicted that, after Week 79 of treatment with LEQEMBI intravenous infusion of 10 mg/kg every 2 weeks, transitioning to a dosing regimen of either LEQEMBI intravenous infusion of 10 mg/kg every 4 weeks or LEQEMBI subcutaneous injection of 360 mg once a week will also continue the reduction in amyloid beta plaque levels. Based on exposure-response modeling, the intravenous (10 mg/kg every 4 weeks) and subcutaneous (360 mg once weekly) maintenance dosing regimens of lecanemab-irmb are predicted to have similar reduction of amyloid beta plaque levels.
An increase in plasma Aβ42/40 ratio (Table 8) and CSF Aβ[1-42] was observed with LEQEMBI 10 mg/kg every two weeks dosing compared to placebo. Exposure-response modeling predicts that, after Week 79 of treatment with LEQEMBI intravenous infusion of 10 mg/kg every 2 weeks, transitioning to a dosing regimen of either LEQEMBI intravenous infusion of 10 mg/kg every 4 weeks or LEQEMBI subcutaneous injection of 360 mg once a week will maintain increases in the plasma Aβ42/40 ratio. Effect of LEQEMBI on Tau Pathophysiology A reduction in plasma p-tau181 (Table 8), CSF p-tau181, and CSF t-tau was observed with LEQEMBI 10 mg/kg every two weeks compared to placebo.
Based on exposure-response modeling, initiation of therapy with either lecanemab-irmb by intravenous administration (10 mg/kg every two weeks) or subcutaneous administration (500 mg once weekly) is predicted to have similar decrease in plasma p-tau181. Exposure-response modeling predicts that, after Week 79 of treatment with LEQEMBI intravenous infusion of 10 mg/kg every two weeks, transitioning to a dosing regimen of LEQEMBI intr… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of LEQEMBI was evaluated in two double-blind, placebo-controlled, parallel-group, randomized studies (Study 1, NCT01767311; Study 2 NCT03887455) in patients with Alzheimer’s disease (patients with confirmed presence of amyloid pathology and mild cognitive impairment [64% of patients in Study 1; 62% of patients in Study 2] or mild dementia stage of disease [36% of patients in Study 1; 38% of patients in Study 2], consistent with Stage 3 and Stage 4 Alzheimer’s disease). In both studies, patients were enrolled with a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0 and a Memory Box score of 0.5 or greater.
All patients had a Mini-Mental State Examination (MMSE) score of ≥22 and ≤30, and had objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler-Memory Scale-IV Logical Memory II (subscale) (WMS-IV LMII). Patients were enrolled with or without concomitant approved therapies (cholinesterase inhibitors and the N-methyl-D-aspartate antagonist memantine) for Alzheimer’s disease. The dosage of 10 mg/kg administered once every 2 weeks by intravenous infusion was assessed in the 18-month placebo-controlled portions of Study 1 and Study 2 and continued in the optional long-term extension in each study.
The effectiveness of subcutaneous LEQEMBI is based on the established effectiveness of intravenous LEQEMBI supported by comparable pharmacokinetic exposures and reductions of amyloid beta plaque level. Transitioning to intravenous 10 mg/kg once every 4 weeks or subcutaneous 360 mg every week after 18 months of dosing is supported by pharmacokinetic and pharmacodynamic modeling using observed data [see Clinical Pharmacology ( 12.2 )] ; however, there are limited data to assess the long-term clinical benefit of transitioning to the dosing regimen of intravenous 10 mg/kg once every 4 weeks or subcutaneous 360 mg every week [see Dosage and Administration ( 2.2 )] .
Study 1 In Study 1, 856 patients were randomized to receive one of 5 doses (161 of which were randomized to the recommended dosing regimen of 10 mg/kg every two weeks) of intravenous infusion of LEQEMBI or placebo (n=247). Of the total number of patients randomized, 71.4% were ApoE ε4 carriers and 28.6% were ApoE ε4 non-carriers. During the study, the protocol was amended to no longer randomize ApoE ε4 carriers to the 10 mg/kg every two weeks dose arm.
ApoE ε4 carriers who had been receiving LEQEMBI 10 mg/kg every two weeks for 6 months or less were discontinued from study drug. As a result, in the LEQEMBI 10 mg/kg every two weeks arm, 30.3% of patients were ApoE ε4 carriers and 69.7% were ApoE ε4 non-carriers. At baseline, the mean age of randomized patients was 71 years, with a range of 50 to 90 years.
Fifty percent of patients were male and 90% were White. In Study 1, a subgroup of 315 patients were enrolled in the amyloid PET substudy; of these, 277 were evaluated at Week 79. Results from the amyloid beta PET substudy are described in Figure 1 and Table 10.
Plasma biomarkers are described in Table 8. Figure 1 : Reduction in Brain Amyloid Beta Plaque (Adjusted Mean Change from Baseline in Amyloid Beta PET Composite, SUVR and Centiloids) in Study 1 Table 10: Results for Amyloid Beta PET in Study 1 Biomarker Endpoints LEQEMBI 10 mg/kg Every Two Weeks Placebo Amyloid Beta PET Composite SUVR N=44 N=98 Mean baseline 1.373 1.402 Adjusted mean change from baseline at Week 79 Difference from placebo -0.306 -0.310 ( P <0.001) 1 0.004 Amyloid Beta PET Centiloid N=44 N=98 Mean baseline 78.0
84.8Adjusted mean change from baseline at Week 79 Difference from placebo -72.5 -73.5 ( P <0.001) 1
1.0N is the number of patients with baseline value. 1 P values were not statistically controlled for multiple comparisons. The primary endpoint was change from baseline on a weighted composite score consisting of selected items from the Clinical Dementia Rating scale Sum of Boxes (CDR-SB), MMSE… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies have not been conducted. Mutagenesis Genotoxicity studies have not been conducted. Impairment of Fertility No studies in animals have been conducted to assess the effects of lecanemab-irmb on male or female fertility.
No adverse effects on male or female reproductive organs were observed in a 39-week intravenous toxicity study in monkeys administered lecanemab-irmb weekly at doses up to 100 mg/kg. The highest dose tested was associated with plasma exposures (C ave ) approximately 27 times that in humans at the recommended human dose (10 mg/kg every two weeks).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies have not been conducted. Mutagenesis Genotoxicity studies have not been conducted. Impairment of Fertility No studies in animals have been conducted to assess the effects of lecanemab-irmb on male or female fertility.
No adverse effects on male or female reproductive organs were observed in a 39-week intravenous toxicity study in monkeys administered lecanemab-irmb weekly at doses up to 100 mg/kg. The highest dose tested was associated with plasma exposures (C ave ) approximately 27 times that in humans at the recommended human dose (10 mg/kg every two weeks).
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE LEQEMBI IQLIK ® (le-KEM-bee eye-klik ) (lecanemab-irmb) 360 mg/1.8 mL injection, for subcutaneous use single-dose prefilled autoinjector This Instructions for Use contains information on how to prepare and use LEQEMBI IQLIK 360 mg/1.8 mL. Before each use of LEQEMBI IQLIK Read this Instructions for Use before you start using LEQEMBI IQLIK and each time you get a refill. There may be new information.
This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. After at least 2 consecutive doses of LEQEMBI IQLIK are given under the direct guidance of your healthcare provider, they will decide if it is appropriate for you or a caregiver to give (administer) LEQEMBI IQLIK. Your healthcare provider should show you or a caregiver how to use LEQEMBI IQLIK the right way before you use it for the first time.
If you have any questions about how to use the autoinjector, contact your healthcare provider. Important information LEQEMBI IQLIK is only given as an injection under the skin (subcutaneous). Do not remove the clear cap until you are ready to inject.
Do not try to take apart the autoinjector at any time. Do not reuse the autoinjector. Do not inject through clothing.
Do not shake the autoinjector. Do not use the autoinjector if the carton or any parts look damaged or has been dropped. Do not hold the autoinjector by the magenta needle cover.
Storing LEQEMBI IQLIK Store the LEQEMBI IQLIK autoinjector in a refrigerator between 36˚F to 46˚F (2˚C to 8°C). Do not freeze. Keep the LEQEMBI IQLIK autoinjector in the original carton until ready to use, to protect it from light.
LEQEMBI IQLIK may be stored at room temperature up to 77°F (25°C) for up to 14 days in the original carton. Do not place it back in the refrigerator if it has been brought to room temperature. Throw away (dispose of) LEQEMBI IQLIK that is out of date, or if it is not stored the right way.
Keep your LEQEMBI IQLIK autoinjector and all medicines out of the reach of children. The LEQEMBI IQLIK 360 mg autoinjector Gather Supplies Preparing to Inject LEQEMBI IQLIK Step 1 Remove carton from the refrigerator and wait 20 minutes for the autoinjector to reach room temperature. Do not try to speed up the warming process in any way because the product may be damaged.
Check the carton. Do not use if the expiration date on the carton has passed. Do not use if the seal on the carton is broken.
Step 2 Check the autoinjector. Do not use if the autoinjector is damaged or has been dropped. Check viewing window.
Do not use if the medicine looks cloudy, discolored, or contains particles. The medicine should be clear and colorless to pale yellow. It is normal to see air bubbles in the window.
Check the expiration date. Do not use if the expiration date on the autoinjector has passed. Step 3 Wash your hands with soap and water or use hand sanitizer.
Step 4 You can inject into the front of your thighs or stomach area (abdomen). If a healthcare provider or a caregiver gives you the injection, they may also do it in the back of your upper arm. Do not inject into moles, scars, bruises, tattoos or into areas where the skin is red, hard, tender or injured.
Use a different injection site at least 1 inch away from last site each time you use LEQEMBI IQLIK. Do not inject into the 2-inch area around the belly button. Injecting LEQEMBI IQLIK Step 5 Clean the injection site with an alcohol wipe and allow the skin to air dry.
Do not touch the injection site after it is cleaned. Do not fan or blow on the cleaned area. Step 6 Remove the clear cap when you are ready to inject.
Hold the autoinjector with 1 hand and firmly pull the clear cap straight off with your other hand. Do not bend or twist the clear cap while pulling it off. Do not put your fingers or hand over the needle.
Doing this may cause a needle injury. Do not put the clear cap back on after it has been removed from the autoinjector. Step 7 Throw away (dispos… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration ( 2.5 ) 8/2025 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.6 , 2.7 ) 7/2026 Contraindications ( 4 ) 8/2025 Warnings and Precautions ( 5.1 ) 12/2025 Warnings and Precautions ( 5.2 , 5.3 ) 8/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 62856-215-01 LEQEMBI® (lecanemab-irmb) injection 500 mg/5 mL (100 mg/ mL) Single-Dose Vial PRINCIPAL DISPLAY PANEL NDC 62856-215-01 LEQEMBI® (lecanemab-irmb) injection 500 mg/5 mL (100 mg/ mL) Single-Dose Vial
PRINCIPAL DISPLAY PANEL NDC 62856-215-01 LEQEMBI® (lecanemab-irmb) injection 500 mg/5 mL (100 mg/ mL) Single-Dose Vial PRINCIPAL DISPLAY PANEL NDC 62856-215-01 LEQEMBI® (lecanemab-irmb) injection 500 mg/5 mL (100 mg/ mL) Single-Dose Vial
PRINCIPAL DISPLAY PANEL NDC 62856-212-01 LEQEMBI® (lecanemab-irmb) injection 200 mg/2 mL (100 mg/ mL) 1 vial per carton PRINCIPAL DISPLAY PANEL NDC 62856-212-01 LEQEMBI® (lecanemab-irmb) injection 200 mg/2 mL (100 mg/ mL) 1 vial per carton
PRINCIPAL DISPLAY PANEL NDC 62856-212-01 LEQEMBI® (lecanemab-irmb) injection 200 mg/2 mL (100 mg/ mL) 1 vial per carton PRINCIPAL DISPLAY PANEL NDC 62856-212-01 LEQEMBI® (lecanemab-irmb) injection 200 mg/2 mL (100 mg/ mL) 1 vial per carton
PRINCIPAL DISPLAY PANEL NDC 62856-220-01 LEQEMBI® lQLIK (lecanemab-irmb) injection 360 mg/1.8 mL PRINCIPAL DISPLAY PANEL NDC 62856-220-01 LEQEMBI® lQLIK (lecanemab-irmb) injection 360 mg/1.8 mL
PRINCIPAL DISPLAY PANEL NDC 62856-220-10 Rx Only LEQEMBI® lQLIK (lecanemab-irmb) injection 360 mg/1.8 mL PRINCIPAL DISPLAY PANEL NDC 62856-220-10 Rx Only LEQEMBI® lQLIK (lecanemab-irmb) injection 360 mg/1.8 mL
PRINCIPAL DISPLAY PANEL NDC 62856-215-01 LEQEMBI® (lecanemab-irmb) injection 500 mg/5 mL (100 mg/ mL) Single-Dose Vial PRINCIPAL DISPLAY PANEL NDC 62856-215-01 LEQEMBI® (lecanemab-irmb) injection 500 mg/5 mL (100 mg/ mL) Single-Dose Vial
PRINCIPAL DISPLAY PANEL NDC 62856-212-01 LEQEMBI® (lecanemab-irmb) injection 200 mg/2 mL (100 mg/ mL) 1 vial per carton PRINCIPAL DISPLAY PANEL NDC 62856-212-01 LEQEMBI® (lecanemab-irmb) injection 200 mg/2 mL (100 mg/ mL) 1 vial per carton
PRINCIPAL DISPLAY PANEL NDC 62856-222-10 LEQEMBI IQIK ® (lecanemab-irmb) Injection For Subcutaneous Injection Only 250 mg/1.25 mL Single-dose prefilled autoinjector. NDC 62856-222-10 LEQEMBI IQIK® (lecanemab-irmb) Injection For Subcutaneous Injection Only 250 mg/1.25 mL Single-dose prefilled autoinjector.
PRINCIPAL DISPLAY PANEL NDC 62856-222-02 Rx Only LEQEMBI IQIK ® (lecanemab-irmb) Injection For Subcutaneous Injection Only 250 mg/1.25 mL 2 single-dose prefilled autoinjectors. Discard after use. NDC 62856-222-02 Rx Only LEQEMBI IQIK® (lecanemab-irmb) Injection For Subcutaneous Injection Only 250 mg/1.25 mL 2 single-dose prefilled autoinjectors. Discard after use.
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Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |