Donanemab Dosage

Medically reviewed by Drugs.com. Last updated on Apr 1, 2025.

Usual Adult Dose for Alzheimer's Disease

Initial dose: 700 mg IV every 4 weeks for 3 doses
Maintenance dose: 1400 mg IV every 4 weeks

Comments:

• Presence of amyloid beta pathology should be confirmed before starting this treatment.
• Administer as an IV infusion over about 30 minutes.
• Consider stopping this drug based on reduction of amyloid plaques to minimal levels on amyloid positron emission tomography (PET) imaging.

Use: For the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

This drug can cause amyloid related imaging abnormalities (ARIA) with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H).

For Patients With ARIA-E:
Clinically asymptomatic and ARIA-E severity on MRI is:

• Mild: Dosing may continue at current dose and schedule.
• Moderate or severe: Suspend dosing until MRI shows radiographic resolution.
• Consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification; resumption of dosing should be guided by clinical judgment.

Clinically mild symptoms and ARIA-E severity on MRI is:

• Mild: Dosing may continue based on clinical judgment.
• Moderate or severe: Suspend dosing until MRI shows radiographic resolution and symptoms resolve.
• Consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification; resumption of dosing should be guided by clinical judgment.

Clinically moderate or severe symptoms and ARIA-E severity on MRI is:

• Mild, moderate, or severe: Suspend dosing until MRI shows radiographic resolution and symptoms resolve.
• Consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification; resumption of dosing should be guided by clinical judgment.

For Patients With ARIA-H:
Clinically asymptomatic and ARIA-H severity on MRI is:

• Mild: Dosing may continue at current dose and schedule.
• Moderate: Suspend dosing until MRI shows radiographic stabilization.
• Resumption of dosing should be guided by clinical judgment; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.
• Severe: Suspend dosing until MRI shows radiographic stabilization and symptoms resolve.
• Use clinical judgment when considering whether to continue therapy or permanently discontinue this drug.

Clinically symptomatic and ARIA-H severity on MRI is:

• Mild or moderate: Suspend dosing until MRI shows radiographic stabilization and symptoms resolve.
• Resumption of dosing should be guided by clinical judgment; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.
• Severe: Suspend dosing until MRI shows radiographic stabilization and symptoms resolve.
• Use clinical judgment when considering whether to continue therapy or permanently discontinue this drug.

Patients who develop intracerebral hemorrhage greater than 1 cm in diameter during therapy: Suspend dosing until MRI shows radiographic stabilization and symptoms, if present, resolve.

• Resumption of dosing should be guided by clinical judgment.

Precautions

US BOXED WARNING:

• AMYLOID RELATED IMAGING ABNORMALITIES (ARIA): Monoclonal antibodies directed against aggregated forms of beta amyloid (including this drug) can cause ARIA, characterized as ARIA-E and ARIA-H. Incidence and timing of ARIA vary among treatments. ARIA generally occurs early in treatment and is usually asymptomatic, but serious and life-threatening events rarely can occur; serious intracerebral hemorrhages greater than 1 cm (some fatal) have occurred with this class of drugs. Since ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke, treating clinicians should consider if these symptoms may be due to ARIA-E before administering thrombolytic therapy in patients treated with this drug. Patients who are apolipoprotein E epsilon 4 (ApoE epsilon 4) homozygotes (about 15% of Alzheimer's disease patients) treated with this drug have a higher incidence of ARIA (including symptomatic, serious, and severe radiographic ARIA) compared to heterozygotes and noncarriers. Testing for ApoE epsilon 4 status is recommended before starting this treatment to inform the risk of developing ARIA. Before testing, prescribers should apprise patients of the risk of ARIA across genotypes and the implications of genetic testing results. Patients should be informed that this drug can be used without genotype testing, but it cannot be determined if they are ApoE epsilon 4 homozygotes and at higher risk for ARIA. Consider the benefit of this drug for treating Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to start therapy.

CONTRAINDICATIONS:

• Known serious hypersensitivity (including anaphylaxis) to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Brain MRI should be obtained before starting this treatment and during treatment before 2nd, 3rd, 4th, and 7th infusions.
• The solution should be visually inspected for the presence of any particulate matter or discolorations before administration.
• Allow the diluted solution to come to room temperature before infusion.
• Administer the entire diluted solution IV over approximately 30 minutes.
• Flush IV line only with 0.9% sodium chloride injection at the end of the infusion (per access specific line maintenance protocol).
• Patients should be monitored postinfusion for a minimum of 30 minutes for any signs and symptoms of infusion-related reactions and hypersensitivity reactions.
• If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.

Storage requirements:

• Unopened vial: Store at 2C to 8C (36F to 46F); store in the outer carton to protect from light.
• If refrigeration is not available: May store at room temperature (20C to 25C [68F to 77F]) for up to 3 days
• Diluted solution: If immediate use is not possible, store refrigerated at 2C to 8C (36F to 46F) for up to 72 hours or at room temperature (20C to 25C [68F to 77F]) for up to 12 hours. Storage times include duration of infusion.
• Do not freeze or shake.

Reconstitution/preparation techniques:

• This drug must be diluted before administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection

Monitoring:

• Nervous system: For ARIA including ARIA-E and ARIA-H

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• This drug may cause ARIA; symptoms of ARIA include headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure. Inform your health care provider if these symptoms occur.
• Concomitant use of antithrombotic or thrombolytic medications can increase the risk of bleeding in the brain.
• Your health care provider will perform MRI scans to monitor for ARIA.
• It is advised to perform testing for ApoE epsilon 4 status before starting treatment. Patients who are ApoE epsilon 4 homozygotes are at a higher risk for ARIA.
• Carry information that you are being treated with this drug.
• Patients should be encouraged to participate in real world data collection (e.g., registries) to help further the understanding of Alzheimer's disease and the impact of Alzheimer's disease treatments.
• Contact your health care provider if hypersensitivity reactions occur.
• There is a risk of infusion-related reactions with this drug, which can present as chills, erythema, nausea, vomiting, difficulty breathing, sweating, headache, chest pain, and high or low blood pressure. Contact your health care provider if infusion-related reactions occur.

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Further information

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