Donanemab is a prescription medicine indicated for the treatment of Alzheimer's disease. It is available as injection for intravenous use. MedsAcross supplies Donanemab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Donanemab-azbt is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. Donanemab-azbt reduces amyloid beta plaques, as evaluated in Study 1.
Source: US FDA prescribing information
Confirm the presence of amyloid beta pathology prior to initiating treatment. Administer KISUNLA as an intravenous infusion over approximately 30 minutes every four weeks as follows: Infusion 1: 350 mg Infusion 2: 700 mg Infusion 3: 1,050 mg Infusion 4 and beyond: 1,400 mg Consider stopping dosing with KISUNLA based on reduction of amyloid plaques to minimal levels on amyloid PET imaging. Obtain a recent baseline brain MRI prior to initiating treatment. Obtain an MRI prior to the 2nd, 3rd, 4th, and 7th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms. Dilution to a final concentration of 4 mg/mL to 10 mg/mL with 0.9% Sodium Chloride Injection, is required prior to administration.
Source: US FDA prescribing information
KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis.
Source: US FDA prescribing information
Boxed warning (amyloid related imaging abnormalities): Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with KISUNLA. Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E ε4 (ApoE ε4) homozygotes compared to heterozygotes and noncarriers. The risk of ARIA-E and ARIA-H is increased in KISUNLA-treated patients with pretreatment microhemorrhages and/or superficial siderosis.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Amyloid Related Imaging Abnormalities Hypersensitivity Reactions Infusion-Related Reactions Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. If refrigeration is not available, may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 3 days. Keep the vial in the outer carton to protect from light. Diluted Solution For storage of the diluted infusion solution see Dosage and Administration.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Donanemab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Kisunla 350 mg/20 mL injectionIntravenous Cold chain | Eli Lilly | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Donanemab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Donanemab, including Kisunla.
Yes. The US FDA first approved Donanemab on 2 July 2024, according to Drugs@FDA.
Yes. Donanemab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Donanemab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Donanemab is classified under ATC code N06DX05 (Donanemab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.