Whoops, lecanemab is not for me. With my damaged brain already running with millions to billions less neurons I'll pass on more brain shrinkage. But I'm not medically trained so don't listen to me.
From this article comes the following paragraphs:
YIKES! FDA Approves Lecanemab Against Alzheimer’s
But there is a new and disturbing fly in the ointment.. A study published in the journal Neurology (March 27, 2023) reveals that anti-amyloid drugs like lecanemab can cause brain shrinkage. The researchers call this accelerated “brain atrophy.”
And this from the article means more reason not to do this. Caution is also advised for patients using anticoagulant medications because of an increased risk of intracerebral haemorrhage.
FDA approves first at-home starting dosage for subcutaneous lecanemab in Alzheimer’s disease
The US Food and Drug Administration (FDA) approved a new starting dosage regimen for the subcutaneous (SC) formulation of lecanemab-irmb (Leqembi IQLIK) for adult patients with Alzheimer’s disease. This approval allows individuals to begin treatment via home administration by themselves or a caregiver, marking a significant update from the previous requirement for an intravenous (IV) starting dosage.
Lecanemab-irmb is an amyloid beta-directed antibody indicated for patients at the mild cognitive impairment or mild dementia stage of Alzheimer’s disease with confirmed amyloid pathology. Before this decision, the SC formulation was only authorised as a maintenance option for patients who had already completed 18 months of IV therapy.
Although the SC formulation was not evaluated in separate large clinical outcome trials, its approval was supported by evidence demonstrating that it produced equivalent results in the body and similar reductions in amyloid plaques compared with the IV formulation.
Common side effects include headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA). ARIA is a known side effect of amyloid-targeting antibodies and typically presents as temporary brain swelling or small spots of bleeding. While often asymptomatic, ARIA can lead to headache, confusion, dizziness, and nausea, and may infrequently cause life-threatening brain oedema.
The prescribing information includes a boxed warning regarding ARIA risks. The FDA noted that patients homozygous for the ApoE ε4 allele have a higher incidence of serious ARIA compared with heterozygotes and non-carriers. Consequently, testing for ApoE ε4 status should be performed before initiating treatment.
Additional adverse reactions associated with SC administration include injection-site reactions such as redness, swelling, and pain. Caution is also advised for patients using anticoagulant medications because of an increased risk of intracerebral haemorrhage.
The approval was granted to Eisai under a priority review designation.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
SOURCE: US Food and Drug Administration
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