Donanemab

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.

• 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.ICD-10: G30.9

• KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )] .contraindicated

Confirm the presence of amyloid beta pathology prior to initiating treatment. ( 2.1 ) Administer KISUNLA as an intravenous infusion over approximately 30 minutes every four weeks as follows ( 2.2 ): 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. ( 2.2 ) Obtain a recent baseline brain MRI prior to initiating treatment. ( 2.3 , 5.1 ) 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. ( 2.3 , 5.1 ) Dilution to a final concentration of 4 mg/mL to 10 mg/mL with 0.9% Sodium Chloride Injection, is required prior to administration. ( 2.4 ) 2.1 Patient Selection Confirm the presence of amyloid beta pathology prior to initiating treatment [see Clinical Pharmacology ( 12.1 )] . 2.2 Dosing Instructions Administer KISUNLA every four weeks as an intravenous infusion over approximately 30 minutes with the recommended dosage and dosing schedule described in Table 1 . KISUNLA must be diluted prior to administration ( see Table 4 ).

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. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI scanning if indicated. ( 2.3 , 5.1 ) Infusion-Related Reactions: The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Consider pre-treatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing. ( 5.3 ) 5.1 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), which can be observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer's disease, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy, such as pretreatment microhemorrhage or superficial siderosis.

The following clinically significant adverse reactions are described elsewhere in the labeling: Amyloid Related Imaging Abnormalities [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Dosing Regimen and Safety A lower incidence of ARIA occurred with the dosing regimen administered in Study 2 (350 mg/700 mg/1,050 mg/1,400 mg; Dosing Regimen 2) as compared to the regimen administered in Study 1 (700 mg/700 mg/700 mg/1,400 mg; Dosing Regimen 1); therefore, Dosing Regimen 2 is recommended for administration of KISUNLA [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14 )] . The safety of KISUNLA has been evaluated in 3727 patients with Alzheimer's disease who received at least one dose of KISUNLA intravenously.

8.1 Pregnancy Risk Summary There are no adequate data on KISUNLA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal studies have been conducted to assess the potential reproductive or developmental toxicity of KISUNLA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. 8.2 Lactation Risk Summary There are no data on the presence of donanemab-azbt in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Published data from other monoclonal antibodies generally indicate low passage of monoclonal antibodies into human milk and limited systemic exposure in the breastfed infant. The effects of this limited exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for KISUNLA and any potential adverse effects on the breastfed infant from KISUNLA or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Metabolism

The pharmacokinetics (PK) of KISUNLA were characterized using a population PK analysis with concentration data collected from 2131 patients with Alzheimer's disease who received KISUNLA in single or multiple doses. Accumulation of <1.3-fold occurs with every-4-week dosing.

• Jul 2, 2024BLABLA761248Eli Lilly Co

1. 1Amyloid Related Imaging Abnormality-oedema/effusion34217%
2. 2Amyloid Related Imaging Abnormality-microhaemorrhages And Haemosiderin Deposits27013%
3. 3Infusion Related Reaction23412%
4. 4Headache1939.5%
5. 5Flushing1406.9%
6. 6Amyloid Related Imaging Abnormalities1236.1%
7. 7Cerebral Haemorrhage1085.3%
8. 8Dizziness934.6%
9. 9Nausea904.4%
10. 10Dyspnoea783.8%
11. 11Cerebral Microhaemorrhage743.6%
12. 12Confusional State703.5%
13. 13Blood Pressure Increased643.2%
14. 14Chills603.0%
15. 15Brain Oedema582.9%

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Donanemab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
  Active not recruiting · Phase 3 · Interventional · 1,500 enrolled · Eli Lilly and Company
  NCT05508789updated 2026-06-03
• A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
  Not yet recruiting · Phase 3 · Interventional · 550 enrolled · Eli Lilly and Company
  NCT07602582updated 2026-05-22
• Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation
  Not yet recruiting · Phase 4 · Interventional · 60 enrolled · Michael Rafii, MD, PhD
  NCT06911944updated 2026-05-15
• A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
  Not yet recruiting · Phase 2 · Interventional · 350 enrolled · Eli Lilly and Company
  NCT07589595updated 2026-05-15
• Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
  Not yet recruiting · Phase 3 · Interventional · 140 enrolled · Eli Lilly and Company
  NCT07571161updated 2026-05-06
• Alzheimer's Tau Platform: Master Protocol
  Not yet recruiting · Phase 2 · Interventional · 900 enrolled · Paul S. Aisen
  NCT06957418updated 2026-04-06
• Alzheimer's Tau Platform: Regimen A - AADvac1
  Not yet recruiting · Phase 2 · Interventional · 450 enrolled · Paul S. Aisen
  NCT07167966updated 2026-04-06
• A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
  Completed · Phase 2 · Interventional · 272 enrolled · Eli Lilly and Company
  NCT03367403updated 2026-03-19
• Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance
  Not yet recruiting · Interventional · 50 enrolled · IRCCS San Raffaele
  NCT07456462updated 2026-03-06
• A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
  Active not recruiting · Phase 3 · Interventional · 2,996 enrolled · Eli Lilly and Company
  NCT05026866updated 2026-01-21

Frequently asked questions

How does Donanemab work?

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.

What is Donanemab used for?

According to FDA labeling, Donanemab carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Donanemab?

Donanemab is classified as Other anti-dementia drugs, Amyloid Beta-directed Antibody Interactions.

What are the brand names for Donanemab?

Donanemab is marketed under brand names including Kisunla.

What are the contraindications for Donanemab?

Donanemab labeling lists contraindications including: KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )] .. Always consult the full prescribing information and a clinician.