SIMPLIFIED INFUSION SCHEDULE REDUCES THE NUMBER OF ADMINISTRATION DAYS VS. DAUNORUBICIN CYTARABINE (DA) THERAPY IN PATIENTS WITH HIGH-RISK* ACUTE MYELOID LEUKAEMIA (AML)1-3

STORING AND INFUSING VYXEOS LIPOSOMAL

The combined storage time for the reconstitution and dilution stages of preparing Vyxeos Liposomal is up to 4 hours at 2 to 8°C†.

This storage time is in addition to the 90 minutes infusion time.

storing-and-infusing

51% of Vyxeos Liposomal patients received their first consolidation as outpatients vs. 6% for DA therapy4

Preparing Vyxeos Liposomal for Administration

A Step-by-Step Walkthrough of How to Prepare Vyxeos Liposomal1

Vyxeos Liposomal is a cytotoxic medicinal product. Applicable special handling and disposal procedures should be followed. The product is intended for single use only. Any unused product should be disposed of in accordance with local requirements for cytotoxic agents.

  • Determine the dose and number of vials of Vyxeos Liposomal based on the individual patient’s BSA as outlined in section 4.2 [of the SmPC]

  • Remove the appropriate number of vials of Vyxeos Liposomal from the refrigerator and equilibrate to the room temperature (15°C to 30°C) for 30 minutes

  • Then, reconstitute each vial with 19 mL of sterile water for injections using a 20 mL 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 it rest for 15 minutes
  • The reconstituted product will be an opaque, purple, homogenous dispersion, essentially free from visual particulates

  • If the reconstituted product is not diluted into an infusion bag immediately, store in a refrigerator (2°C to 8°C) for up to 4 hours
  • Following the storage of reconstituted product in the vial for up to 4 hours at 2°C to 8°C in an upright position, the reconstituted product must immediately be diluted into an infusion solution and run for the 90-minute infusion time
  • Reconstituted product in the vial and reconstituted product which has been diluted into an infusion solution are stable for a maximum combined storage time of up to 4 hours when stored at 2°C to 8°C, The 4-hour stability period for the reconstituted product in the vial does not allow for an additional 4-hour stability period after the appropriate dose from the reconstituted vial is diluted into the infusion solution
  • The 4-hour stability period when reconstituted product diluted into the infusion bag is stored at 2°C to 8°C does not include the time required for reconstitution or the 90-minute infusion time
  • The diluted infusion solution must be immediately infused for the 90-minute infusion time following the up to 4-hour stability period
  • Calculate the volume of reconstituted Vyxeos liposomal required using the following formula: [volume required (mL) = dose of daunorubicin (mg/m2) x patient’s BSA (m2)/2.2 (mg/mL)]. The concentration of the reconstituted solution is 44 mg/20 mL (2.2 mg/mL) daunorubicin and 100 mg/20 mL (5 mg/mL) cytarabine
  • Gently invert each vial five times prior to withdrawing the concentrate for dilution

  • Aseptically withdraw the calculated volume of reconstituted Vyxeos Liposomal from the vial(s) with a sterile syringe and transfer it to an infusion bag containing 500 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, or 5% glucose. 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
  • If the diluted infusion solution is not used immediately, store in a refrigerator (2°C to 8°C) for up to 4 hours
  • Gently invert the bag to mix the solution after refrigeration

Administering Vyxeos Liposomal

Administration Instructions1

  • Do not mix Vyxeos Liposomal with, or administer as an infusion with, other medicinal products
  • Administer Vyxeos Liposomal by constant intravenous infusion over 90 minutes via an infusion pump through a central venous catheter or a peripherally inserted central catheter. An in-line membrane filter may be used for the intravenous infusion of Vyxeos Liposomal, provided the minimum pore diameter of the filter is greater than or equal to 15 µm
  • Flush the line after administration with sodium chloride 9 mg/mL (0.9%) solution for injection

This medicinal product could have potential risk for the environment due to the cytotoxic and antimitotic activities, which could induce possible reproductive effects.

All materials used for dilution and administration should be disposed of according to local procedures applicable to the discarding of antineoplastic agents.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.

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ADVERSE EVENTS REPORTING

Adverse events should be reported. Reporting forms and information for the UK can be found at https://yellowcard.mhra.gov.uk/

For Ireland, reporting forms and information can be found at: www.hpra.ie

Adverse events should also be reported to Jazz Pharmaceuticals at AEreporting@jazzpharma.com

IE-VYX-2100004 l March 2021