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Aduhelm Dosage

Generic name: aducanumab 100mg in 1mL
Dosage form: injection, solution
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Drugs.com. Last updated on Apr 30, 2022.

2.1 Patient Selection

Confirm the presence of amyloid beta pathology prior to initiating treatment [see Clinical Pharmacology (12.1)].

Dosing Instructions

After an initial titration, the recommended dosage of ADUHELM is 10 mg/kg (see Table 1). ADUHELM is administered as an intravenous (IV) infusion over approximately one hour every four weeks and at least 21 days apart.

Table 1: Dosing Schedule
IV Infusion
(every 4 weeks)
ADUHELM Dosage (administered over approximately one hour)
Infusion 1 and 2 1 mg/kg
Infusion 3 and 4 3 mg/kg
Infusion 5 and 6 6 mg/kg
Infusion 7 and beyond 10 mg/kg

2.3 Monitoring and Dosing Interruptions for Amyloid Related Imaging Abnormalities

ADUHELM can cause amyloid related imaging abnormalities -edema (ARIA-E) and -hemosiderin deposition (ARIA-H) [see Warnings and Precautions (5.1)].

Monitoring for ARIA

Obtain recent (within one year) brain magnetic resonance imaging (MRI) prior to initiating treatment. Obtain MRIs prior to the 5th infusion (first dose of 6 mg/kg), 7th infusion (first dose of 10 mg/kg), 9th infusion (third dose of 10 mg/kg), and 12th infusion (sixth dose of 10 mg/kg).

Recommendations for Dosing Interruptions in Patients with ARIA

If dosing is resumed following a temporary suspension, dosing may resume at that same dose and titration schedule prior to the dosing suspension. The benefits of reaching and maintaining the 10 mg/kg dosage should be considered when evaluating a potential dose suspension.

ARIA-E

The dosing interruptions for patients with ARIA-E are provided in Table 2.

Table 2: Dosing Recommendations for Patients with ARIA-E

1. Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment.

Clinical Symptom Severity ARIA-E Severity on MRI
Mild Moderate Severe
Asymptomatic May continue dosing at current dose and schedule Suspend dosing1 Suspend dosing1
Mild
May continue dosing based on clinical judgment Suspend dosing1
Moderate or Severe
Suspend dosing1

ARIA-H

The dosing interruptions for patients with ARIA-H are provided in Table 3.

Table 3: Dosing Recommendations for Patients with ARIA-H

1. Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment.

2. Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; use clinical judgment in considering whether to continue treatment or permanently discontinue ADUHELM.

Clinical Symptom Severity ARIA-H Severity on MRI
Mild Moderate Severe
Asymptomatic May continue dosing at current dose and schedule Suspend dosing1 Suspend dosing2
Symptomatic
Suspend dosing1 Suspend dosing1

In patients who develop intracerebral hemorrhage greater than 1 cm in diameter during treatment with ADUHELM, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. In Studies 1 and 2, dosing was permanently discontinued in patients who developed intracerebral hemorrhage greater than 1 cm in diameter. Use clinical judgment in considering whether to continue treatment or permanently discontinue ADUHELM.

Resuming ADUHELM After Missed Dose

If an infusion is missed, resume administration at the same dose as soon as possible [see Dosage and Administration (2.2)]. Infusions are to be administered every 4 weeks and at least 21 days apart.

Dilution Instructions

  • Use aseptic technique when preparing the ADUHELM diluted solution for intravenous infusion. Each vial is for single-dose only. Discard any unused portion.
  • Calculate the dose, total volume of ADUHELM solution required, and the number of vials needed based on the patient's actual body weight. Each vial contains an ADUHELM concentration of 100 mg per mL. More than one vial may be needed for a full dose.
  • Select the correct vial(s) for the required volume [see Dosage Forms and Strengths (3)].
  • Check that the ADUHELM solution is clear to opalescent and colorless to yellow solution. Do not use if opaque particles, discoloration, or other foreign particles are present.
  • Remove the flip-off cap from the vial. Insert the syringe needle into the vial through the center of the rubber stopper.
  • Withdraw the required volume of ADUHELM from the vial(s) and add to an infusion bag of 100 mL of 0.9% Sodium Chloride Injection, USP. Do not use other intravenous diluents to prepare the ADUHELM diluted solution.
  • Gently invert the infusion bag containing the ADUHELM diluted solution to mix completely. Do not shake.
  • After dilution, immediate use is recommended. If not administered immediately, store the diluted solution of ADUHELM in 0.9% Sodium Chloride Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 3 days, or at room temperature up to 30°C (86°F) for up to 12 hours.
  • Prior to infusion, allow the ADUHELM diluted solution to warm to room temperature.

Administration Instructions

  • Visually inspect the ADUHELM diluted solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen.
  • Infuse ADUHELM diluted solution intravenously over approximately one hour through an intravenous line containing a sterile, low-protein binding, 0.2 or 0.22 micron in-line filter.
  • Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction [see Warnings and Precautions (5.2)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.