Donanemab: Difference between revisions

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 {{MedTemplate
-| generic            = Donanemab
+| brand           = Kisunla
-| brand              = Kisunla
+| classes         = Anti-amyloid beta (Aβ) monoclonal antibody, targets pyroglutamated Aβ in plaques
-| structure          =
+| mechanism       = Humanized IgG1 monoclonal antibody specifically targeting '''N-terminally truncated, pyroglutamated Aβ''' (an early modified form found primarily in established plaques). Designed for rapid plaque clearance. Patients can stop treatment once amyloid is cleared on PET (unique among approved anti-amyloid mAbs).
-| classes            = Anti-dementia, Monoclonal antibody
+| uses            = Alzheimer disease (MCI or mild dementia stage), FDA-approved July 2024
-| mechanism          = Amyloid-beta plaque-clearing antibody
+| starting_dose   = 700 mg IV q4w × 3 doses, then 1400 mg IV q4w; may discontinue when amyloid PET shows clearance
-| uses               =
+| preparations    = 350 mg/20 mL vial for IV infusion
-| starting_dose      =
+| fda_max         = 1400 mg q4w
-| preparations       =
+| routes          = IV infusion every 4 weeks
-| fda_max           =
+| onset           = Amyloid PET clearance within months; cognitive benefit over 18 months
-| routes             =
+| duration        = Treatment can be discontinued upon achieving amyloid clearance
-| onset              =
+| halflife        = ~12.1 days
-| duration           =
+| bioavailability = 100% (IV)
-| halflife           =
+| pregnancy       = Limited data
-| bioavailability    =
+| legal           = Rx; ARIA monitoring required
-| pregnancy          =
+| intro           = '''Donanemab''' (brand name Kisunla) is a humanized monoclonal antibody targeting N-terminally truncated, pyroglutamated Aβ, an Aβ form found predominantly in established plaques. FDA-approved in July 2024 for Alzheimer disease (MCI/mild AD). Unique among approved anti-amyloid mAbs: patients can '''discontinue treatment once amyloid PET shows plaque clearance''', typically within 12-18 months. This stop-criterion (a finite course rather than indefinite biweekly infusions like lecanemab) is donanemab's main clinical advantage.
-| legal              =
-| intro              =
+Pivotal trial (TRAILBLAZER-ALZ 2): ~35% slowing of cognitive decline on integrated Alzheimer Disease Rating Scale (iADRS) over 18 months. The trial enriched for tau-positive patients. As with other anti-amyloid mAbs, ARIA is the principal safety concern, with higher rates than lecanemab (especially ARIA-E in ~25% of treated patients).
-| pharmacokinetics   =
+| pharmacodynamics= Humanized IgG1 targeting pyroglutamated Aβ (Aβ3-42(pE)). Aggressive plaque clearance via microglial phagocytosis.
-| pharmacodynamics   =
+| effects         = ARIA-E (~24-27% in trials), ARIA-H. Some symptomatic ARIA cases including deaths reported. Infusion reactions. Headache. APOE ε4 carriers at higher ARIA risk.
-| indications        =
+| interactions     = <pharmaInteractions/>
-| dosing             =
-| effects            =
-| contraindications  =
-| interactions       =
-| pregnancy_details  =
-| monitoring         =
-| counseling         =
-| anecdotes          =
-| seealso            =
-| references         =
 }}
-[[Category:Anti-dementia]]
+[[Category:Anti-Dementia Medicines]]
+[[Category:Anti-Amyloid Monoclonal Antibodies]]
+[[Category:Alzheimer Disease Medicines]]

MDElliottMD (talk | contribs)