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Leqembi

Leqembi

lecanemab

Manufacturer:

Eisai

Distributor:

Zuellig Pharma

Marketer:

Eisai
Concise Prescribing Info
Contents
Lecanemab
Indications/Uses
Slowing the progression of Alzheimer's disease in patients w/ mild cognitive impairment or mild dementia stage of disease.
Dosage/Direction for Use
IV Adult Recommended dose: 10 mg/kg as infusion over approx 1 hr once every 2 wk.
Contraindications
Special Precautions
Possible hypersensitivity reactions including angioedema, bronchospasm & anaphylaxis; promptly discontinue infusion upon the 1st observation of any signs or symptoms consistent w/ a hypersensitivity reaction & initiate appropriate therapy. Possible amyloid related imaging abnormalities (ARIA) characterized as ARIA w/ edema (ARIA-E) & ARIA w/ hemosiderin deposition (ARIA-H), focal neurologic deficits & intracerebral haemorrhages in >1 cm diameter can occur. Increased risk of ARIA in ApoE ε4 homozygotes; perform ApoE ε4 status testing prior to treatment initiation to inform risk of developing ARIA. Concomitant administration w/ anticoagulants or thrombolytic agent (eg, tissue plasminogen activator). Patients w/ factors that indicate an increased risk for intracerebral haemorrhage (eg, prior cerebral haemorrhage >1 cm in greatest diameter, >4 microhaemorrhages, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation); in particular for patients who need to be on anticoagulant therapy. Baseline brain MRI & periodic monitoring w/ MRI are recommended; enhanced clinical vigilance for ARIA is recommended during the 1st 14 wk of treatment. Perform clinical evaluation prior to continuing treatment if patient experiences symptoms suggestive of ARIA & if ARIA is observed on MRI. History of transient ischemic attacks, stroke or seizures w/in 12 mth of screening; patient w/ bleeding disorder that was not under adequate control. Possible infusion-related reactions including fever & flu-like symptoms (eg, chills, generalized aches, feeling shaky & joint pain), nausea, vomiting, hypotension, HTN & oxygen desaturation. Reduce infusion rate or discontinue; initiate appropriate therapy in the event of an infusion-related reaction. Consider prophylactic treatment w/ antihistamines, acetaminophen, NSAIDs or corticosteroids prior to future infusions. Pregnancy & lactation. Childn.
Adverse Reactions
Infusion-related reactions, headache, ARIA-E, cough, diarrhea; ARIA-H, CND superficial siderosis, rash, nausea, vomiting.
MIMS Class
Neurodegenerative Disease Drugs
ATC Classification
N06DX04 - lecanemab ; Belongs to the class of other anti-dementia drugs.
Presentation/Packing
Form
Leqembi conc for soln for infusion 100 mg/mL
Packing/Price
2 mL x 1's;5 mL x 1's
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