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Medicines > generic : Lactated Ringer's solution or None & bioavailability: 100% (IV)

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generic: (Click arrow to add another value)
brand:
Aduhelm (1) · Kisunla (1) · Leqembi (1) · Vyepti (1) · Zulresso (1)
classes:
Anti-amyloid beta (Aβ) monoclonal antibody (3) · Anti-CGRP ligand monoclonal antibody (1) · GABA-A positive allosteric modulator (1) · Neuroactive steroid (1) · targets protofibrils (1) · targets pyroglutamated Aβ in plaques (1)
mechanism:
None (3) · 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) · Humanized IgG1 monoclonal antibody binding CGRP peptide; IV infusion enables fastest onset of any CGRP mAb (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Alzheimer disease (FDA accelerated approval June 2021; '''withdrawn from market January 2024''' by manufacturer Biogen).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) · Alzheimer disease (MCI or mild dementia stage); FDA accelerated approval Jan 2023 → traditional approval July 2023 (1) · Postpartum depression (PPD) in adults (1) · Preventive treatment of migraine in adults (1)
starting dose:
10 mg/kg IV every 2 weeks (1) · 100 mg IV every 3 months; may increase to 300 mg IV every 3 months (1) · 700 mg IV q4w × 3 doses, then 1400 mg IV q4w; may discontinue when amyloid PET shows clearance (1) · Single 60-hour continuous IV infusion: 30 mcg/kg/h × 4h → 60 mcg/kg/h × 20h → 90 mcg/kg/h × 28h → 60 mcg/kg/h × 4h → 30 mcg/kg/h × 4h (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:
100 mg/20 mL vial, single-use (1) · 100 mg/mL vial for IV infusion (1) · 200 mg/2 mL, 500 mg/5 mL vials for IV infusion (1) · 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:
10 mg/kg q2w (1) · 1400 mg q4w (1) · 300 mg/quarter (1) · Single 60-hour course (1) · Withdrawn 2024 (1)
routes:
Intravenous (continuous infusion in a REMS-certified facility) (1) · Intravenous infusion (1) · IV infusion (60 min) every 2 weeks; outpatient or infusion-center setting (1) · IV infusion every 4 weeks (2)
onset:
Amyloid PET clearance within months; cognitive benefit over 18 months (1) · Antidepressant effect within hours of infusion start; sustained at 30 days (1) · Effect demonstrated within 24 hours in some patients (1) · PET Aβ reduction over months (1) · Slowing of cognitive decline over 18 months (modest effect, ~27% relative slowing) (1)
duration:
3-month dosing interval (1) · Ongoing dosing (1) · Single infusion course (1) · Treatment can be discontinued upon achieving amyloid clearance (1) · Withdrawn (1)
halflife:
~12.1 days (1) · ~25 days (1) · ~27 days (1) · ~5-7 days (1) · ~9 hours (terminal) (1)
bioavailability: (Click arrow to add another value)
pregnancy:
Discontinued/withdrawn (1) · Limited data (2) · Limited data; avoid (1) · Medicine is structurally identical to endogenous allopregnanolone; pregnancy considerations relate to breastfeeding during/after infusion. Limited data; brief interruption of breastfeeding considered (1)
legal:
Rx (1) · Rx; ARIA monitoring required (1) · Rx; REMS program required (excessive sedation/loss of consciousness during infusion) (1) · Rx; REMS-like program for ARIA monitoring (1) · Withdrawn from US market January 2024 (1)
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