Vyxeos
Prescribing
Information (PI) PI
  • THE PATIENTS
  • THE FORMULATION
  • THE DATA
  • THE DOSING
  • THE RESOURCES
  • PI
the data
The dosing the dosing

Vyxeos Liposomal infusions
last just 90 minutes1

INDUCTION
CONSOLIDATION

Vyxeos Liposomal provides optimal benefit when
used for both induction and consolidation therapy2,3

Induction cycles
  • or
Consolidation cycles
  • or

Treatment should be continued as long as the patient continues to benefit or until disease progression, up to a maximum of 2 induction courses and 2 consolidation courses1

Infusion schedule the dosing

Vyxeos Liposomal offers a less time-intensive regimen vs
conventional chemotherapy**1

Vyxeos Liposomal
Induction
Days
  • 1
  • 3
  • 5
Daunorubicin 44 mg/m2 and cytarabine 100 mg/m2
90 min infusion
Second induction + consolidation
Days
  • 1
  • 3
Second induction: Daunorubicin 44 mg/m2
and cytarabine 100 mg/m2
Consolidation: Daunorubicin 29 mg/m2
and cytarabine 65 mg/m2
90 min infusion
Conventional chemotherapy**
Induction
Days
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
Cytarabine 100 mg/m2 /day
Continuous infusion for 7 days
Days
  • 1
  • 2
  • 3
Daunorubicin 60 mg/m2/day
15 min IV push daily
Second induction + consolidation
Days
  • 1
  • 2
  • 3
  • 4
  • 5
Cytarabine 100 mg/m2/day
Continuous infusion for 5 days
Days
  • 1
  • 2
Daunorubicin 60 mg/m2/day
15 min IV push daily
** Comparator arm conventional chemotherapy is 7+3 in induction, 5+2 in second induction and consolidation where given
Dosing calculator Dosing calculator

By using the slider bar below, you can calculate the number
of vials and volume of Vyxeos Liposomal required per infusion

Body surface area (m2)
INDUCTION (44/100 mg)/m2
Number of vials
Volume to withdraw (mL)†
CONSOLIDATION (29/65 mg)/m2
Number of vials
Volume to withdraw (mL)†
Induction: Days 1, 3 and 5. Second induction and consolidation: Days 1 and 31
† Rounded to the nearest 0.1 mL

Calculating the dose

To determine the dose and number of vials you will need for each patient, calculate the volume of reconstituted Vyxeos Liposomal required using the following formula:1

Dose of daunorubicin (mg/m2) x
patient’s body surface area (m2)
2.2 mg/mL
= mL volume required

Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine1

After reconstitution, the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine, encapsulated in liposomes in a fixed combination in a 1:5 molar ratio1

Please refer to the SmPC for dosing considerations with Vyxeos Liposomal1

Preparation and administration Preparation and administration

A step-by-step walkthrough of how to prepare and administer
Vyxeos Liposomal

play

Please review the video and the instructions below together. Please see the SmPC for full information on preparing Vyxeos Liposomal

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 µm1

  • Calculate Vyxeos Liposomal dose using the dosing calculator above, or see the SmPC for more details1
  • Remove the vials of Vyxeos Liposomal from the refrigerator
  • Equilibrate at room temperature for 30 minutes
  • Do not heat, vortex, or shake vigorously
  • Reconstitute each vial with 19 mL of sterile water for injection using a sterile syringe
  • 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
  • After reconstitution, leave to rest for 15 minutes
  • The reconstituted product will be an opaque, purple, homogenous, dispersion, essentially free from particulates
  • Vyxeos Liposomal has up to 4 hours stability when stored at 2°C to 8°C
  • The combined storage time for reconstituted product in the vial and reconstituted product diluted into an infusion bag must not exceed 4 hours
  • Storage time does not include time for reconstitution or infusion
  • 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 the refrigerator at 2°C-8°C for up to 4 hours prior to infusion time
  • 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 0.9% sodium chloride injection or 5% dextrose injection. There may be residual product remaining in the vial. Discard unused portion
  • Gently invert the bag to mix the solution
  • If the diluted solution is not used immediately, store in the refrigerator at 2°C-8°C for up to 4 hours
  • Vyxeos Liposomal should not be mixed with any other medications
  • The combined storage time for reconstituted product in the vial and reconstituted product diluted into an infusion bag must not exceed 4 hours

Please refer to the SmPC for dosing considerations with Vyxeos Liposomal1

This website is intended for European Healthcare Professionals only.
REFERENCES
  • Vyxeos Liposomal. European Summary of Product Characteristics.
  • Kolitz JE et al. Leuk Lymphoma 2020;61(3):631-40.
  • Lancet JE et al. J Clin Oncol 2018;36(26):2684-92.

ADVERSE EVENTS REPORTING

Adverse events should be reported. Healthcare Professionals are asked to report any suspected adverse events via their national reporting system. For the UK, reporting forms and information can be found at yellowcard.mhra.gov.uk, or search for Yellow Card MHRA in the Google Play or Apple App Store. Adverse events should also be reported to Jazz Pharmaceuticals at AEreporting@jazzpharma.com

Job code: INT-VYX-2200141
Date of Preparation: July 2023
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Prescribing Information