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:

  1. Visually inspect the vial for particulate matter and discoloration before use
  2. Do not use if the solution is cloudy, discolored, or contains particles
  3. The solution should appear clear to opalescent, colorless to slightly yellow to slightly brown

Dilution Process:

  1. Use aseptic technique when preparing the solution for infusion
  2. Prior to administration, Kisunla must be diluted with 0.9% sodium chloride injection
  3. 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)
  4. Add the calculated volume to an infusion bag containing 0.9% sodium chloride
  5. 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