aducanumab (Rx)

Brand and Other Names:Aduhelm, aducanumab-avwa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 100mg/mL (1.7-mL, 3-mL single-dose vials)

Alzheimer Disease

Indicated for treatment of Alzheimer disease

Administered as IV infusion every 4 weeks and at least 21 days apart

Initiate treatment in patients with mild cognitive impairment or mild dementia stage of disease, the population studied in clinical trials

Safety or effectiveness data are not available on initiating treatment at earlier or later stages of the disease than were studied

Dosing titration schedule

Infusions 1-2: 1 mg/kg IV q4Weeks

Infusions 3-4: 3 mg/kg IV q4Weeks

Infusions 5-6: 6 mg/kg IV q4Weeks

Infusion 7 and beyond: 10 mg/kg IV q4Weeks

Dosage Modifications

Renal or hepatic impairment

  • No studies were conducted to evaluate pharmacokinetics in patients with renal or hepatic impairment
  • Not expected to undergo renal elimination or metabolism by hepatic enzymes

Dosing Considerations

Magnetic resonance imaging (MRI)

  • Prior to initiation: Obtain recent (ie, within at least 1 year) brain MRI
  • Before 7th infusion (1st dose of 10 mg/kg) and 12th infusion (6th dose of 10 mg/kg)
  • Enhanced clinical vigilance recommended if radiographic severe ARIA-H observed
    • If ≥10 new incident microhemorrhages or >2 focal areas of superficial siderosis (radiographic severe amyloid-related imaging abnormalities due to hemosiderin deposition [ARIA-H]) is observed, continue treatment with caution only after a clinical evaluation and a follow-up MRI demonstrating radiographic stabilization (eg, no increase in size or number of ARIA-H)

Safety and efficacy not established

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Adverse Effects

>10%

Amyloid-related imaging abnormalities-edema (ARIA-E) (35%)

Headache (21%)

ARIA-H microhemorrhage (19%)

ARIA-H superficial siderosis (15%)

Falls (15%)

1-10%

Diarrhea (9%)

Confusion/delirium/altered mental status/disorientation (8%)

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Warnings

Contraindications

None

Cautions

Angioedema and urticaria reported; promptly discontinue infusion upon first observation of any signs or symptoms consistent with a hypersensitivity reaction, and initiate appropriate therapy

Amyloid-related imaging abnormalities (ARIA)

  • May cause ARIA-E; observed on MRI as brain edema, sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis
  • ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time; other symptoms include headache, confusion, dizziness, vision changes, or nausea
  • Majority of ARIA observed during first 8 doses, particularly during titration; enhanced clinical vigilance recommended
  • Safety in patients with any pretreatment localized superficial siderosis, ≥10 brain microhemorrhages, and/or with a brain hemorrhage >1 cm within 1 year of treatment initiation has not been established
  • For ARIA-E or mild/moderate ARIA-H, continue treatment
  • If dosing is temporarily suspended, resume at same dose and titration schedule
  • There are no systematic data on continued dosing following detection of radiographically moderate or severe ARIA
  • Refer to prescribing information for ARIA MRI classification criteria
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Pregnancy & Lactation

Pregnancy

There are no adequate data on use in pregnant females to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Lactation

No data are available on presence of aducanumab in human milk, effects on the breastfed infants, or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

High affinity, fully human IgG1 monoclonal antibody that targets beta amyloid and binds to aggregated forms of beta-amyloid; preferentially binds to parenchymal over vascular amyloid; reduces plaque formation on neurons

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Administration

IV Incompatibilities

Do not use other diluents besides 0.9% NaCl to prepare diluted solution

IV Compatibilities

0.9% NaCl

IV Preparation

Calculate dose, total drug volume required, and number of vials needed; each vial contains a drug concentration of 100 mg/mL

Visually inspect solution in vial(s); solution is clear to opalescent and colorless to yellow; discard if opaque particles, discoloration, or other foreign particles are present

Using aseptic technique, withdraw required volume from vial(s) and add into a 0.9% NaCl 100-mL infusion bag; do not use other IV diluents to prepare diluted solution

Gently invert infusion bag to mix completely; do not shake

After dilution, immediate use is recommended

If not used immediately, refrigerate diluted solution at 2-8ºC (36-46ºF) for up to 3 days, or store at room temperature up to 30ºC (86ºF) for up to 12 hr

IV Administration

Before infusion if diluted solution was refrigerated, allow it to warm to room temperature

Infuse IV over 1 hr through an IV–line containing a sterile, low–protein binding, 0.2– or 0.22–micron in–line filter

Promptly discontinue infusion upon first observation of any signs or symptoms consistent with a hypersensitivity-type reaction

Missed dose

  • Resume administration at the same dose as soon as possible
  • Infusions are administered q4Weeks and at least 21 days apart

Storage

Unopened vials

  • Refrigerate at 2-8ºC (36-46ºF) in original carton until use to protect from light; do not freeze or shake
  • If no refrigeration is available, may store in its original carton to protect from light at room temperature up to 25ºC (77ºF) for up to 3 days
  • Prior to dilution
    • Unopened vials may be removed from and returned to refrigerator, if necessary, when kept in the original carton; not to exceed a total of 24 hr at room temperature (up to 25ºC [77ºF])

Diluted solutions

  • After dilution, immediate use is recommended
  • If not used immediately, refrigerate diluted solution at 2-8ºC (36-46ºF) for up to 3 days, or store at room temperature up to 30ºC (86ºF) for up to 12 hr
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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.