Active Ingredient: Lecanemab
Lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease (Early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams lecanemab per kilogram of body weight, once every 2 weeks.
The recommended dose of lecanemab is 10 mg/kg body weight administered as an intravenous (IV) infusion once every 2 weeks.
Treatment with lecanemab should be discontinued once the patient progresses to moderate Alzheimer's disease.
During treatment with lecanemab, cognitive function testing and clinical symptom assessment should occur approximately every 6 months. The cognitive testing and symptom progression should be used to assess whether the patient has progressed to moderate Alzheimer's dementia, and/or if the clinical course otherwise suggests that lecanemab has not demonstrated effectiveness in the patient, and inform the decision as to whether treatment with lecanemab should be discontinued.
Lecanemab can cause ARIA, characterized as ARIA with oedema (ARIA-E), which can be observed on MRI as brain oedema or sulcal effusions, and ARIA with haemosiderin deposition (ARIA-H), which includes microhaemorrhage and superficial siderosis. In addition to ARIA, intracerebral haemorrhages greater than 1 cm in diameter have occurred in patients treated with lecanemab.
Obtain a recent (within 6 months) baseline brain MRI prior to initiating treatment with lecanemab to evaluate for pre-existing ARIA. Obtain an MRI prior to the 5th, 7th and 14th infusions. If a patient experiences symptoms suggestive of ARIA at any time during treatment, clinical evaluation should be performed including an MRI.
Dosing may continue in asymptomatic, mild radiographic ARIA-E cases. Suspend dosing for any symptomatic or radiographically moderate or severe ARIA-E. A follow-up MRI to assess for resolution 2 to 4 months after initial identification should be performed. Once the MRI demonstrates radiographic resolution and symptoms, if present, resolve, resumption of dosing should be guided by clinical judgment.
Use clinical judgment in considering whether to continue dosing in patients with recurrent ARIA-E. After the second occurrence of symptomatic or radiographically moderate or severe ARIA-E, treatment with lecanemab should be discontinued.
Dosing may continue in asymptomatic, mild radiographic ARIA-H cases. Suspend dosing for any symptomatic mild or moderate or radiographically moderate ARIA-H. A follow-up MRI to assess for stabilisation 2 to 4 months after initial identification should be performed. Once the MRI demonstrates radiographic stabilisation and symptoms, if present, resolve, resumption of dosing should be guided by clinical judgement. In the event of radiographically or symptomatic severe ARIA-H, treatment with lecanemab should be permanently discontinued.
Lecanemab should be permanently discontinued if intracerebral haemorrhage greater than 1 cm in diameter occurs.
If an infusion is missed, the next dose should be administered as soon as possible.
Lecanemab is for intravenous use only. Lecanemab is administered as an intravenous infusion over approximately 1 hour once every 2 weeks. For the first infusion, the patient should be observed for approximately 2.5 hours following completion of the infusion for signs and symptoms of infusion related reactions.
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