Quick answers
- What is Donanemab-azbt used for?
- The FDA-approved label (Kisunla, Eli Lilly and Company, December 30, 2025) says: “KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Donanemab-azbt have a boxed warning?
- Yes. The FDA label for Kisunla has a boxed warning (“WARNING: AMYLOID RELATED IMAGING ABNORMALITIES”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Donanemab-azbt?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Donanemab-azbt been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Donanemab-azbt?
- 1 company lists prescription products of Donanemab-azbt in the FDA NDC Directory, including Eli Lilly and Company.
What Donanemab-azbt is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. …
— FDA label: Kisunla, Eli Lilly and Company, effective December 30, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: AMYLOID RELATED IMAGING ABNORMALITIES
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Kisunla |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Eli Lilly and Company1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761248 KISUNLA | Eli Lilly Co | July 2, 2024 | 1, latest July 1, 2025 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2687972, 2687979 |
|---|---|
| SPL set ID of the quoted label | 190352d4-ef62-4679-b4fa-e846e2766afa |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761248 |
| Active ingredients (FDA) | DONANEMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kisunla, Eli Lilly and Company, effective December 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →