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Kisunla (donanemab-azbt)
donanemab
Black Box Warnings .
Amyloid-Related Imaging Abnormalities (ARIA)
can cause ARIA w/ edema (ARIA-E) and ARIA w/ hemosiderin deposition (ARIA-H); incidence and timing vary; usually asymptomatic and occurs early in tx, though serious, life-threatening, or fatal events can occur; serious cerebral hemorrhage observed, incl. fatal; consider if focal neurologic deficits due to ARIA-E vs. ischemic stroke before admin. thrombolytic tx; apolipoprotein E epsilon 4 homozygotes have incr. ARIA incidence vs. heterozygotes and noncarriers; test for apolipoprotein E epsilon 4 status before tx start; before testing, discuss w/ pts ARIA risk across genotypes and implications of genetic testing results; inform pts they may receive tx w/o genotype testing, but it cannot be determined if they are apolipoprotein E epsilon 4 homozygotes at incr. ARIA risk; consider benefit vs. risk when deciding to initiate tx
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = donanemab-azbt
Alzheimer dz, mild cognitive impairment or mild dementia
- [1400 mg IV q4wk]
- Start: 700 mg IV q4wk x3 doses; Info: for pts w/ confirmed amyloid beta pathology; see pkg insert for dose interruptions based on brain MRI and sx severity in pts w/ amyloid-related imaging abnormalities; consider premed w/ antihistamine, acetaminophen, corticosteroid if infusion rxn occurs
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: apolipoprotein E epsilon 4 allele, homozygous
- caution: cerebral hemorrhage risk
- caution: cerebral amyloid angiopathy
- caution: cerebral hemorrhage >1 cm
- caution: >2 cerebral microhemorrhage
- caution: superficial siderosis
- caution: cerebral edema, vasogenic
- caution: white matter dz, severe
Drug Interactions .
Overview
donanemab
amyloid beta-directed antibody
- antiplatelet/anticoagulant effects
Monitor/Modify Tx
- alteplase
- anagrelide
- antithrombin
- apixaban
- argatroban
- aspirin
- bivalirudin
- cangrelor
- caplacizumab
- cilostazol
- clopidogrel
- dabigatran
- dalteparin
- defibrotide
- dipyridamole
- edoxaban
- enoxaparin
- eptifibatide
- fondaparinux
- heparin
- prasugrel
- reteplase
- rivaroxaban
- tenecteplase
- ticagrelor
- tirofiban
- vorapaxar
- warfarin
Adverse Reactions .
Serious Reactions
- cerebral edema, amyloid-related
- sulcal effusion, amyloid-related
- superficial siderosis, amyloid-related
- cerebral microhemorrhage, amyloid-related
- cerebral hemorrhage
- seizures
- hypersensitivity rxn
- anaphylaxis
- angioedema
- infusion rxn, severe
- intestinal obstruction
- intestinal perforation
Common Reactions
- amyloid-related imaging abnormalities
- headache
- infusion rxn
- hypersensitivity rxn
Safety/Monitoring .
Monitoring Parameters
brain MRI at baseline, before 2nd, 3rd, 4th, and 7th dose, then as clinically indicated; screen for apolipoprotein E epsilon 4 allele before tx start
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: proteolytic degradation; CYP450: unknown
Excretion: non-renal; Half-life: 12.1 days
Subclass: Dementia/Alzheimer Disease
Mechanism of Action
binds to insoluble N-truncated pyroglutamate amyloid beta, reducing amyloid beta plaques in the brain (monoclonal antibody)
Formulary .
No Formulary Selected
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