PRODUCT IDENTIFICATION
Brand Name: Kisunla™
Generic Name: donanemab-azbt
Therapeutic Category: Amyloid beta-directed antibody for Alzheimer's disease
AVAILABLE DOSAGE FORMS AND STRENGTHS
Injection: 350 mg/20 mL (17.5 mg/mL) solution in a single-dose vial
STORAGE CONDITIONS OF VIAL
Store refrigerated at 2°C to 8°C (36°F to 46°F)
Keep in original carton to protect from light
Do not freeze
Do not shake
PREPARATION AND RECONSTITUTION
Preparation Steps:
Visually inspect the vial for particulate matter and discoloration before use
Do not use if the solution is cloudy, discolored, or contains particles
The solution should appear clear to opalescent, colorless to slightly yellow to slightly brown
Dilution Process:
Use aseptic technique when preparing the solution for infusion
Prior to administration, Kisunla must be diluted with 0.9% sodium chloride injection
Remove the required volume from the vial(s) according to dosage:
For 700 mg dose: Use 40 mL (2 vials)
For 1400 mg dose: Use 80 mL (4 vials)
Add the calculated volume to an infusion bag containing 0.9% sodium chloride
Gently invert the bag to mix; do not shake
SPECIAL CONSIDERATIONS
Handling: Do not shake vials
No reconstitution needed as product is supplied as a solution
DILUENT INFORMATION
Compatible diluent: 0.9% sodium chloride injection only
RESULTANT CONCENTRATION
Dose-dependent concentration after dilution in sodium chloride
COMPATIBLE SOLUTIONS
0.9% sodium chloride injection
IV BAG SIZE
Not explicitly specified, but should be appropriate for diluting either 40 mL (700 mg dose) or 80 mL (1400 mg dose)
DILUTION SPECIFICATIONS
Must be diluted with 0.9% sodium chloride prior to administration
SPECIAL EQUIPMENT REQUIREMENTS
Use aseptic technique
Use of a 0.2 or 0.22 micron in-line filter is required during administration
FINAL APPEARANCE
The diluted solution should appear clear to opalescent, colorless to slightly yellow to slightly brown
STABILITY INFORMATION
Unopened Vial: Store refrigerated at 2°C to 8°C (36°F to 46°F)
Diluted Solution:
Use immediately after preparation
If not used immediately, may be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours
If refrigerated, allow the diluted solution to warm to room temperature before administration
LIGHT PROTECTION
Protect from light during storage
Keep in original carton until time of use
HAZARD ASSESSMENT
Not explicitly classified as hazardous or cytotoxic in available information
Standard biological precautions should be followed
PACKAGE INSERT REVISION DATE
July 2024
Note: This information is compiled from the available data. https://www.fda.gov/media/180803/download
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