Usual Adult Dose for Alzheimer's Disease

IV infusion of 10 mg/kg over approximately 1 hour, once every two weeks

Comments:

• This drug is approved under accelerated approval based on reductions in amyloid beta plaques observed in patients treated.
• Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
• Presence of amyloid beta pathology should be confirmed before starting this treatment.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosing recommendations for patients with ARIA-E:

• Clinically asymptomatic
• Mild (Severity on MRI): Dosing may be continued
• Moderate or Severe (Severity on MRI): Dosing should be suspended
• Clinically mild symptoms
• Mild (Severity on MRI): Dosing can be continued based on clinical judgment
• Moderate or Severe (Severity on MRI): Dosing should be suspended
• Clinically moderate or severe: Dosing should be suspended

• Clinically asymptomatic
• Mild (Severity on MRI): Dosing may be continued
• Moderate or Severe (Severity on MRI): Dosing should be suspended
• Clinically symptomatic: Dosing should be suspended

Precautions

CONTRAINDICATIONS: None

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:

• The solution should be visually inspected for the presence of any particulate matter or discolorations before administration.
• Allow the drug to come to room temperature before infusion.
• The entire volume of solution should be infused over one hour via an intravenous line equipped with a terminal low-protein binding 0.2 micron in-line filter.
• Flush intravenous line to ensure complete drug delivery.
• Patient should be monitored for any signs and symptoms of an infusion-related reaction.
• The infusion rate can be reduced, or infusion can be discontinued based on severity of infusion related reactions and patients should be treated appropriately as clinically indicated. Pre-medications can be administered as needed.

• Store at 2C to 8C (36F to 46F).
• Store in the original carton to protect from light.
• Do not freeze or shake.

• Solution should be used immediately after dilution. If not, then, prepared solution can be stored refrigerated at 2C to 8C (36F to 46F) or at room temperature up to 30C (86F) for up to 4 hours.
• Do not freeze.

• The drug product must be diluted in 250 mL of 0.9% sodium chloride injection, USP.
• Refer to manufacturer product information for calculation of dose based on patient's body weight.

• Monitor for amyloid related imaging abnormalities including edema (ARIA-E) and hemosiderin deposition (ARIA-H).
• Brain magnetic resonance imaging (MRI) should be obtained (within 1 year) before starting this treatment and during treatment before 5th, 7th, and 14th infusions.

• Patients should be advised to read FDA approved patient labeling.
• Patients should be informed about the adverse reactions this drug may cause, such amyloid related imaging abnormalities (ARIA) and infusion-related reactions.
• Patients should be informed about the symptoms of ARIA such as headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure and should reach out to their healthcare provider if they develop any of these.
• Patients should be informed that concomitant use of antithrombotic or thrombolytic medications can increase the risk of bleeding in the brain.
• Patients should be made aware that periodic MRI monitoring is required.
• Patients who are ApoE E4 homozygotes are more likely to develop ARIA, and a test for the presence of ApoE E4 genotype is available.
• Patients should be informed about the risk of infusion related reactions which can present as flu-like symptoms, nausea, vomiting, and changes in blood pressure, most of which occur with the first infusion.
• Patients should be encouraged to participate in the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) which is a voluntary provider-enrolled patient registry that collects information on treatments for Alzheimer's disease.

Frequently asked questions

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