Kisunla (Donanemab-azbt) Drug Info

Donanemab-azbt (Kisunla) represents a significant advancement in Alzheimer disease (AD) treatment, particularly for early-stage patients. Below are key clinical pearls for healthcare professionals:

Indications & Patient Selection

Approved for early symptomatic Alzheimer disease, including mild cognitive impairment and mild dementia stages with confirmed amyloid pathology via PET or CSF biomarkers.
Most effective in patients with low-to-medium tau pathology (35% disease progression slowing vs. 22% in mixed tau populations).

Dosing Protocol

Initial phase: 700 mg IV every 4 weeks × 3 doses
Maintenance: 1400 mg IV every 4 weeks thereafter
Stopping criteria: Therapy can be discontinued once amyloid plaques are reduced to minimal levels on PET imaging (achieved in 17-69% of patients by 76 weeks).

Administration Essentials

Requires 30-minute IV infusion with 0.9% NaCl dilution to 4-10 mg/mL.
Pre-infusion checks:
- Baseline brain MRI
- APOE ε4 genotyping (higher ARIA risk in homozygotes)
- Amyloid confirmation
Infusion reactions: Monitor for fever, chills, hypotension, or dyspnea. Pre-medication with antihistamines/steroids may be considered.

Safety Monitoring

ARIA (Amyloid-Related Imaging Abnormalities):
- MRI required before 2nd, 3rd, 4th, and 7th infusions
- 24% incidence of ARIA-Edema (ARIA-E) in trials
- Suspend dosing for symptomatic ARIA; permanent discontinuation for severe cases
Other risks: Microhemorrhages (19.1%), superficial siderosis (15.5%)

Efficacy Evidence

TRAILBLAZER-ALZ 2 trial (N=1,736):
- 35.1% slower decline on iADRS vs placebo (low/medium tau group)
- 39% reduced risk of progressing to next disease stage
- Amyloid plaque reduction: 61% at 6 months, 84% at 18 months

Patient Education Points

Emphasize disease modification rather than cure
Discuss infusion commitment: Monthly visits for ≥6 months
Review ARIA symptoms: Headache, confusion, visual changes
Highlight stopping potential: Reduced treatment burden if plaques clear

Practice Considerations

Use shared decision-making tools to weigh benefits vs risks (ARIA, cost, infusion logistics)
Coordinate with radiologists for standardized MRI monitoring
Consider amyloid PET availability and insurance coverage barriers

This monoclonal antibody offers a unique stop-and-monitor treatment paradigm, but requires careful patient selection and multidisciplinary management to optimize safety outcomes.

[1] https://www.pharmacytimes.com/view/fda-approves-donanemab-azbt-for-early-symptomatic-alzheimer-disease

[2] https://www.drugs.com/monograph/donanemab-azbt.html

[3] https://www.neurologylive.com/view/guidance-safe-use-donanemab-ad-clinical-settings-gil-rabinovici

[4] https://www.veteranshealthlibrary.va.gov/medicationsva/203,a624048

[5] https://www.saintlukeskc.org/health-library/donanemab-azbt-injection

[6] https://www.pharmacytimes.com/view/kisunla-from-eli-lilly

[7] https://www.medcentral.com/drugs/monograph/189031-324037/donanemab-azbt-intravenous

[8] https://medlineplus.gov/druginfo/meds/a624048.html

[9] https://assets.ctfassets.net/plyq12u1bv8a/5WKR7TZgj7toZ2QWorcsXB/4453f5006ecdcb350caf0b3e124cd748/PG238_Kisunla__donanemab-azbt__v1.pdf

[10] https://medicalpolicy.bcbstx.com/content/dam/bcbs/medicalpolicy/pdf/rx/RX501.177_2025-03-15.pdf

[11] https://hhs.iowa.gov/media/14833/download?inline

[12] https://www.webmd.com/drugs/2/drug-189031/donanemab-azbt-intravenous/details