Preparation of VYXEOS

  • Step 1

    Vyxeos Preparation - Step 1
    • Calculate the VYXEOS dose based on daunorubicin and individual patient’s BSA
    • Calculate the number of vials of VYXEOS based on the daunorubicin dose
  • Step 2

    Vyxeos Preparation - Step 2
    • Equilibrate the appropriate number of vials of VYXEOS to room temperature for 30 minutes
  • Step 3

    Vyxeos Preparation - Step 3
    • Reconstitute each vial with 19 mL of Sterile Water for Injection using a sterile syringe and immediately thereafter start a 5-minute timer
    • Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds
    • Do not heat, vortex, or shake vigorously
    • After reconstitution, let rest for 15 minutes
    • The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visible particulates
    • After reconstitution (but before final dilution), each mL will contain 2.2 mg of daunorubicin and 5 mg of cytarabine
  • Step 4

    Vyxeos Preparation - Step 4
    • Gently invert each vial 5 times prior to withdrawing the reconstituted product for further dilution
    • If the reconstituted product is not diluted into an infusion bag immediately, store in refrigerator at 2°C to 8°C for up to 4 hours
  • Step 5

    Vyxeos Preparation - Step 5
    • Calculate the volume of reconstituted VYXEOS required using the following formula:
      [volume required (mL) = dose of daunorubicin (mg/m2) X patient’s BSA (m2) ÷ 2.2 (mg/mL)]
    • Aseptically withdraw the calculated volume of the reconstituted product from the vial(s) with a sterile syringe and transfer it to an infusion bag containing 500 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
      • There may be residual product remaining in the vial. Discard unused portion
    • Gently invert the bag to mix the solution. The dilution of the reconstituted product results in a deep purple, translucent, homogeneous dispersion, free from visible particulates
    • If the diluted infusion solution is not used immediately, store in refrigerator at 2°C to 8°C for up to 4 hours
    • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Only solutions without visible particles should be used