LEQEMBI 100 mg/mL
lecanemab · INJECTION, SOLUTION · Eisai Inc.
LEQEMBI is a injection, solution containing lecanemab at 100 mg/mL, taken intravenous. Manufactured by Eisai Inc..
Key Facts
- Brand Name
- LEQEMBI
- Generic Name
- lecanemab
- NDC Code (Product)
62856-215- Manufacturer
- Eisai Inc.
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761269
- Drug Class
- Amyloid Beta-directed Antibody [EPC]
- Marketing Start
- 01/06/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 within approximately one week prior to the 3 rd , 5 th , 7 th , and 14 th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms. ( 2.4 , 5.1 ) Recommended starting dosage: 10 mg/kg once every 2 weeks administered after dilution as an intravenous infusion over approximately one hour. ( 2.2 ) After 18 months, continue treatment once every 2 weeks 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 ) 2.1 Patient Selection Confirm the presence of amyloid beta pathology prior to initiating treatment [see Clinical Pharmacology ( 12.1 )] . 2.2 Recommended Dosage Initiate LEQEMBI as an intrav…
Contraindications
4 CONTRAINDICATIONS LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI or LEQEMBI IQLIK. 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 of LEQEMBI or LEQEMBI IQLIK. ( 4 )
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. ( 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. 6.1 Clinical 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…
Frequently Asked Questions
What is LEQEMBI used for?
LEQEMBI contains lecanemab. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is LEQEMBI a controlled substance?
LEQEMBI is not classified as a controlled substance by the DEA.
What is the generic name for LEQEMBI?
The generic name for LEQEMBI is lecanemab. There are 1 other brand versions of lecanemab.
What is the NDC code for LEQEMBI 100 mg/mL?
The NDC (National Drug Code) for LEQEMBI 100 mg/mL is 62856-215, listed by Eisai Inc..