Usual Adult Dose for Alzheimer's Disease

Titration is required for treatment initiation: Doses are infused over 1 hour every 4 weeks:

• Infusion 1 and 2: 1 mg/kg IV
• Infusion 3 and 4: 3 mg/kg IV
• Infusion 5 and 6: 6 mg/kg IV

• Administer via IV infusion approximately every 4 weeks and at least 21 days apart.
• Study patients in the clinical trials had mild cognitive impairment or mild dementia stage of disease; there are no safety or

• This drug has been approved under an accelerated approval based on reduction in amyloid beta plaques observed in patients treated in clinical studies; continued approval may be contingent upon verification of clinical benefit in confirmatory trials.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Amyloid Related Imaging Abnormalities (ARIA):

• If 10 or more new incident microhemorrhages or greater than 2 focal areas of superficial siderosis (radiographic severe ARIA-H) are 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).
• In clinical studies, temporary dose suspension was required for radiographically moderate or severe ARIA-E and radiographically moderate ARIA-H; permanent discontinuation of dosing was required for radiographically severe ARIA-H.
• ARIA MRI Classification Criteria of Radiographic Severity: Consult manufacture package labeling for table used in clinical studies

• If dosing is temporarily suspended, dosing may resume at that same dose and titration schedule

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.
Safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied (i.e., mild cognitive impairment or mild dementia stage of disease) are unknown.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer via IV infusion over approximately 1 hour every 4 weeks
• Administer via IV line containing a 0.2 or 0.22 micron in-line filter
• Minimum time between infusions should be 21 days

• Unopened vial: Store refrigerated (36F to 46F [2C to 8C]) in original carton to protect from light; do not freeze or shake; may be stored unopened in original carton at room temperature (up to 77F [25C]) for up to 3 days
• Prior to dilution, unopened vials may be removed from and returned to the refrigerator if necessary, when kept in the original carton; total combined time out of refrigerator with protection from light should not exceed 24 hours at room temperature

• Add required volume of drug to 100 mL of 0.9% sodium chloride
• Gently invert infusion bag to mix; do not shake
• Administer immediately after dilution; however, if that is not possible, may refrigerate at 36F to 46F (2C to 8C) for up to 3 days, or at room temperature up to 86F (30C) for up to 12 hours
• If refrigerated, allow to warm to room temperature prior to infusion

• Use 0.9% sodium chloride as diluent; do not use other IV diluents to prepare the diluted solution

• This drug is approved under accelerated approval based on reduction in amyloid beta plaques; continued approval may be contingent upon verification of clinical benefit in confirmatory trials.

• Obtain a brain magnetic resonance imaging (MRI) prior to initiating treatment (within 1 year); repeat MRIs should be performed prior to the 7th and 12th infusion and as clinically indicated

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients/caregivers should understand that this drug may cause amyloid related imaging abnormalities; symptoms such as headache, confusion, dizziness, vision changes, or nausea should be reported promptly to their healthcare provider.