LEQEMBI lecanemab 100 mg/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Amyloid Beta-directed Antibody class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 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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0.18 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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4.99 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.
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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.Inactive ingredient FAQ
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💲 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 | $105.66 | $211.32 / 2 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0174 | $1.342 / J0174 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leqembi 100 mg/mLthis 62856-0212-01 | Eisai | 1 vial | — | — | FDA listed | — |
| Leqembi 100 mg/mL 62856-0215-01 | Eisai | 1 vial | — | — | FDA listed | — |
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⏳ 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.
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- 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 | Jan 6, 2035 |
Is there a biosimilar for LEQEMBI 200 MG/2 ML VIAL?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62856-0212-01 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-212-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2023-01-06 | Active |
🧭 About this NDC listing & data coverage
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| 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 | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 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…
💊 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…
🤒 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…
👥 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…
🧬 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…
💬 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…