Description

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LEQEMBI is indicated for the treatment of Alzheimer’s disease. Buy Leqembi (lecanemab) Online 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. 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 (lecanemab-irmb) injection is a preservative-free, sterile, clear to opalescent, and colorless to pale yellow solution for intravenous use by infusion after dilution. LEQEMBI is supplied in single-dose vials available in concentrations of 500 mg/5 mL (100 mg/mL) or 200 mg/2 mL (100 mg/mL). 10 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. Best Place to Buy Leqembi (lecanemab) Online without Prescription.

INDICATIONS AND USAGE

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. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on a reduction in amyloid beta plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

DOSAGE FORMS AND STRENGTHS

Injection:

• 500 mg/5 mL (100 mg/mL) solution in a single-dose vial 
• 200 mg/2 mL (100 mg/mL) solution in a single-dose vial 

DOSAGE AND ADMINISTRATION 

– Confirm the presence of amyloid beta pathology prior to initiating treatment.

– The recommended dosage is 10 mg/kg which must be diluted and then administered as an intravenous infusion over approximately one hour, once every two weeks. (2.2)

– Obtain a recent (within one year) brain MRI prior to initiating treatment to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA). (2.3, 5.1)

– Obtain an MRI prior to the 5th, 7th, and 14th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on the type, severity, and presence of symptoms. (2.3, 5.1)

– Dilution in 250 mL of 0.9% Sodium Chloride Injection, USP, is required prior to administration. (2.4)

– Administer as an intravenous infusion over approximately one hour via a terminal low-protein binding 0.2-micron in-line filter. Best Place to Buy Leqembi (lecanemab) Online without Prescription.

WARNINGS AND PRECAUTIONS 

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), which can be 5 observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis. ARIA-H can occur spontaneously in patients with Alzheimer’s disease. 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 is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur. 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.

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