Tyvalzi (Aducanumab) Dosing for Injection
Tyvalzi (aducanumab) is administered as a monthly intravenous infusion titrated to a target dose of 10 mg/kg over a 6-month period. 1
Dosing Schedule
The medication follows a specific titration protocol over the first 6 months:
- Infusion 1 (Week 0): 1 mg/kg IV
- Infusion 2 (Week 4): 1 mg/kg IV
- Infusion 3 (Week 8): 3 mg/kg IV
- Infusion 4 (Week 12): 3 mg/kg IV
- Infusion 5 (Week 16): 6 mg/kg IV
- Infusion 6 (Week 20): 6 mg/kg IV
- Infusion 7 and beyond (Week 24+): 10 mg/kg IV every 4 weeks 1, 2
Key Administration Points
Titrate to the highest dose (10 mg/kg) to maximize therapeutic benefit, as recommended by expert consensus. 1 The pivotal EMERGE and ENGAGE trials demonstrated that the high-dose regimen (10 mg/kg target) was necessary to achieve clinical endpoints. 2
Route: Intravenous infusion only—this is not a subcutaneous injection despite the question's phrasing. 1, 2
Frequency: Monthly (every 4 weeks) after completing the titration schedule. 1, 2
Patient Selection Criteria
Aducanumab should be restricted to patients with:
- Early Alzheimer's disease (mild cognitive impairment due to AD or mild AD dementia) 1
- Confirmed brain amyloid via amyloid PET imaging 1, 2
- Age 50-85 years 2
Critical Safety Monitoring
Obtain MRI scans at these mandatory timepoints:
- Prior to initiating therapy
- During dose titration (before infusions 5,7, and 9)
- At week 52
- Any time the patient develops symptoms suggestive of ARIA 1
Amyloid-related imaging abnormalities (ARIA-edema) are the most common adverse event. 1, 2 The dose titration schedule was specifically designed to reduce ARIA-E incidence. 3
Dose Modifications
Interrupt or discontinue treatment for:
- Symptomatic ARIA
- Moderate-to-severe ARIA on imaging 1
Approximately 61% of participants with ARIA-E remained asymptomatic, but monitoring remains essential. 3
Clinical Context
The 10 mg/kg dose demonstrated a 22% reduction in clinical decline on the CDR-SB scale in the EMERGE trial, though the ENGAGE trial did not meet its primary endpoint. 2 Both trials showed dose- and time-dependent reduction in brain amyloid levels. 2, 3