Aducanumab

What is Aducanumab?

• Aducanumab (Aduhelm) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease.

What are the uses of this medicine?

• This medicine is used to treat people with Alzheimer's disease.

How does this medicine work?

• Aducanumab-avwa is a human, immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease.
• Aduhelm reduces amyloid beta plaques, as evaluated in Studies 1, 2, and 3.

Who Should Not Use this medicine ?

• This medication have no usage limitations.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Titration is required for treatment initiation.
• Obtain a recent (within one year) brain MRI prior to initiating treatment.

Recommended Dosage

• The recommended maintenance dosage is 10 mg/kg administered as an intravenous infusion over approximately one hour every four weeks.
• Obtain MRIs prior to the 7th and 12th infusions. If radiographic severe ARIA-H is observed, treatment may be continued with caution only after a clinical evaluation and a follow-up MRI demonstrates radiographic stabilization (i.e., no increase in size or number of ARIA-H).

Administration

• Dilution in 100 mL of 0.9% Sodium Chloride Injection, USP, is required prior to administration.
• Administer as an intravenous infusion over approximately one hour via a 0.2 or 0.22 micron in-line filter.
• Aduhelm is given through a needle placed in your vein (intravenous (IV) infusion) in your arm.
• Aduhelm is given every 4 weeks.
• Each infusion will last about 1 hour.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 170 mg/1.7 mL (100 mg/mL) solution in a single-dose vial
• 300 mg/3 mL (100 mg/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Aduhelm

What side effects can this medication cause?

The most common side effects of this medicine include:

• swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
• headache
• fall

What special precautions should I follow?

• Aduhelm can cause amyloid related imaging abnormalities-edema (ARIA-E), which can be observed on MRI as brain edema or sulcal effusions, and amyloid related imaging abnormalities-hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis.
• Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction, and initiate appropriate therapy.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on Aduhelm use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: aducanumab-avwa
• Inactive ingredients: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and water for injection

Who manufactures and distributes this medicine?

• Manufactured by: Biogen Inc., Cambridge, MA 02142, U.S. License #1697

What should I know about storage and disposal of this medication?

Unopened Vial

• Store in original carton until use to protect from light.
• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Do not freeze or shake.
• If no refrigeration is available, Aduhelm may be stored unopened in its original carton to protect from light at room temperature up to 25°C (77°F) for up to 3 days.
• Prior to dilution, unopened vials of Aduhelm may be removed from and returned to the refrigerator if necessary, when kept in the original carton. Total combined time out of refrigeration with protection from light should not exceed 24 hours at room temperature up to 25°C (77°F).

• Dailymed label info on Aducanumab
• FDA Aducanumab

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