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Medicines > generic: None & classes: Anti-amyloid beta (Aβ) monoclonal antibody & routes: IV infusion every 4 weeks

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generic: (Click arrow to add another value)
brand:
Aduhelm (1) · Kisunla (1)
classes: (Click arrow to add another value)
mechanism:
None (1) · 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Alzheimer disease (FDA accelerated approval June 2021; '''withdrawn from market January 2024''' by manufacturer Biogen).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) · Alzheimer disease (MCI or mild dementia stage), FDA-approved July 2024 (1)
starting dose:
700 mg IV q4w × 3 doses, then 1400 mg IV q4w; may discontinue when amyloid PET shows clearance (1) · Was 1 mg/kg IV q4w × 2, then 3 mg/kg × 2, then 6 mg/kg × 2, then 10 mg/kg q4w (1)
preparations:
350 mg/20 mL vial for IV infusion (1) · Was: 170 mg/1.7 mL, 300 mg/3 mL vials for IV infusion (1)
fda max:
1400 mg q4w (1) · Withdrawn 2024 (1)
routes: (Click arrow to add another value)
onset:
Amyloid PET clearance within months; cognitive benefit over 18 months (1) · PET Aβ reduction over months (1)
duration:
Treatment can be discontinued upon achieving amyloid clearance (1) · Withdrawn (1)
halflife:
~12.1 days (1) · ~25 days (1)
bioavailability:
100% (IV) (2)
pregnancy:
Discontinued/withdrawn (1) · Limited data (1)
legal:
Rx; ARIA monitoring required (1) · Withdrawn from US market January 2024 (1)

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