Donanemab: Difference between revisions
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{{MedTemplate | {{MedTemplate | ||
| brand = Kisunla | |||
| brand | | classes = Anti-amyloid beta (Aβ) monoclonal antibody, targets pyroglutamated Aβ in plaques | ||
| 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 | | uses = Alzheimer disease (MCI or mild dementia stage), FDA-approved July 2024 | ||
| mechanism | | 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). | ||
| 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. | ||
| interactions = <pharmaInteractions/> | |||
| effects | |||
| interactions | |||
}} | }} | ||
[[Category:Anti-Dementia Medicines]] | [[Category:Anti-Dementia Medicines]] | ||
[[Category:Anti- | [[Category:Anti-Amyloid Monoclonal Antibodies]] | ||
[[Category:Alzheimer Disease Medicines]] | |||
Latest revision as of 17:01, 21 May 2026
Anti-amyloid beta (Aβ) monoclonal antibody, targets pyroglutamated Aβ in plaques
Donanemab
Kisunla
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.
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).
Humanized IgG1 targeting pyroglutamated Aβ (Aβ3-42(pE)). Aggressive plaque clearance via microglial phagocytosis.
Experience
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Problems
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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.
Pharmacodynamics
Interactions
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Summary
Classes
Anti-amyloid beta (Aβ) monoclonal antibody, targets pyroglutamated Aβ in plaques
Common uses
Alzheimer disease (MCI or mild dementia stage), FDA-approved July 2024
Pharmacy
Starting dose
700 mg IV q4w × 3 doses, then 1400 mg IV q4w; may discontinue when amyloid PET shows clearance
Preparations
350 mg/20 mL vial for IV infusion
US FDA Max
1400 mg q4w
Pharmacology
Routes
IV infusion every 4 weeks
Onset
Amyloid PET clearance within months; cognitive benefit over 18 months
Duration
Treatment can be discontinued upon achieving amyloid clearance
Half-life
~12.1 days
Bioavailability
100% (IV)
Pregnancy
Limited data
Legal status
Rx; ARIA monitoring required
Purported 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).