Lecanemab Infusion Protocol
Premedication Recommendations
Premedication with antihistamines, NSAIDs, or corticosteroids should be considered for subsequent infusions if infusion-related reactions occur, though routine premedication is not mandated by the FDA label for initial dosing. 1
- The FDA label for lecanemab does not require routine premedication before the first infusion 1
- If infusion reactions occur, consider premedication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids 1
- Based on appropriate use recommendations, clinicians should develop protocols for managing infusion reactions, which may include premedication strategies 2
Infusion Administration Protocol
Lecanemab should be administered as a 10 mg/kg intravenous infusion over approximately one hour through an intravenous line containing a terminal low-protein binding 0.2 micron in-line filter. 1
Preparation Steps:
- Calculate the dose based on actual body weight at 10 mg/kg 1
- Dilute the required volume of lecanemab (100 mg/mL concentration) in 250 mL of 0.9% Sodium Chloride Injection, USP 1
- Visually inspect for particulate matter; solution should be clear to opalescent and colorless to pale yellow 1
- If not used immediately, store refrigerated at 2°C to 8°C for up to 4 hours, or at room temperature up to 30°C for up to 4 hours 1
Infusion Technique:
- Allow diluted solution to warm to room temperature before infusion 1
- Infuse over approximately one hour through an IV line with a terminal low-protein binding 0.2 micron in-line filter 1
- Flush the infusion line to ensure all medication is administered 1
Monitoring Protocol
During Infusion:
Monitor continuously for signs or symptoms of infusion-related reactions throughout the one-hour infusion period. 1
- Watch for symptoms including headache, confusion, visual changes, dizziness, nausea, and gait difficulty 1
- The infusion rate may be reduced or discontinued if reactions occur, with appropriate therapy administered as clinically indicated 1
Management of Infusion Reactions:
- Mild reactions (Grade 1/2): Slow or stop the infusion rate, provide symptomatic treatment, and restart at a reduced rate once stable 3
- Severe reactions (Grade 3/4): Stop the infusion immediately, provide aggressive symptomatic treatment including corticosteroids if needed 3
After Infusion:
Patients should be observed for a minimum of 1-2 hours after infusion completion, with education provided about potential delayed symptoms up to 24 hours post-infusion. 4
- Post-infusion monitoring should continue for at least 1-2 hours 4
- Educate patients about delayed reactions that can occur up to 24 hours after infusion 4
- Infusion-related reactions occurred in 24.5% of patients in clinical trials, most commonly within the first few infusions 5
ARIA Monitoring Requirements
MRI monitoring is mandatory before initiating treatment and at regular intervals to detect amyloid-related imaging abnormalities (ARIA), which can be serious or fatal. 1, 2
MRI Schedule:
- Baseline MRI required before treatment initiation 2
- Regular interval MRIs throughout treatment to monitor for ARIA-E and ARIA-H 1, 5
- ARIA-E typically occurs within 3-6 months of treatment initiation 5
ARIA Management:
- Asymptomatic mild ARIA-E: May continue dosing 1
- Asymptomatic moderate/severe ARIA-E or any symptomatic ARIA-E: Suspend dosing until MRI demonstrates radiographic resolution and symptoms resolve 1
- Follow-up MRI should be considered 2-4 months after initial identification to assess for resolution 1
Critical Safety Considerations
APOE4 genotyping is recommended before treatment, as APOE4 carriers have significantly higher ARIA risk (16.8% for carriers, 34.5% for homozygotes). 2, 5