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Medicines > fda max: Withdrawn 2024 & routes: IV infusion every 4 weeks & onset: PET Aβ reduction over months

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generic:
None (1)
brand:
Aduhelm (1)
classes:
Anti-amyloid beta (Aβ) monoclonal antibody (1)
mechanism:
Human IgG1 monoclonal antibody targeting aggregated forms of amyloid-β (Aβ), soluble oligomers and insoluble fibrils. Reduces Aβ plaque burden on PET imaging via Fc-mediated microglial clearance. Whether plaque reduction translates to clinical benefit is the core controversy. (1)
uses:
Alzheimer disease (FDA accelerated approval June 2021; '''withdrawn from market January 2024''' by manufacturer Biogen). At time of approval indicated for MCI or mild dementia stage of AD. (1)
starting dose:
Was 1 mg/kg IV q4w × 2, then 3 mg/kg × 2, then 6 mg/kg × 2, then 10 mg/kg q4w (1)
preparations:
Was: 170 mg/1.7 mL, 300 mg/3 mL vials for IV infusion (1)
fda max: (Click arrow to add another value)
routes: (Click arrow to add another value)
onset: (Click arrow to add another value)
duration:
Withdrawn (1)
halflife:
~25 days (1)
bioavailability:
100% (IV) (1)
pregnancy:
Discontinued/withdrawn (1)
legal:
Withdrawn from US market January 2024 (1)

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