Prescribing information

   

 

Offering a formulation suitable for your paediatric patients

 

 

REVOLADE is also available as a powder for oral suspension (PfOS). Incorporating treatment into daily life is now easier for paediatric immune thrombocytopenia (ITP) patients, as well as those who stuggle to swallow a tablet1

 

Each REVOLADE PfOS kit contains:1

  • 30 (25 mg) sachets of REVOLADE for oral suspension
  • 1 reusable mixing bottle with lid and cap
  • 30 single-use 20 mL oral dosing syringes

When switching between formulations, platelet counts should be monitored weekly for 2 weeks as the PfOS may lead to higher REVOLADE exposure than the tablet formulation1

Image of REVOLADE pill packet.
 

 

This PfOS formulation has demonstrated a similar, well-tolerated safety profile to the tablet formulation in healthy adult volunteers. In a single-dose, open-label, randomised-sequence, crossover study, adverse events (AEs) were reported in 42.5% (n=17/40) of volunteers during treatment. All reported AEs were mild in intensity with the exception of 1 moderate case of increased aspartate aminotransferase (AST); there were no serious AEs2

 

How to take REVOLADE PfOS1

1.

In the mixing bottle add:

  • 20 mL of cool/cold water
  • the prescribed number of sachets

    Step-by-step illustration on how to take REVOLADE powder for oral solution.

     

    2.

    Shake gently for at least 20 seconds and transfer the suspension to the oral dosing syringe by turning the mixing bottle and syringe upside down

    Step-by-step illustration on how to take REVOLADE powder for oral solution.

     

    3.

    Place the tip of the oral dosing syringe inside the mouth and slowly push the plunger all the way down

    • When giving a dose of REVOLADE PfOS to a child, place the tip of the syringe on the inside of the child's cheek and slowly push the plunger all the way down

    Step-by-step illustration on how to take REVOLADE powder for oral solution.

     

    If medicine remains in the bottle, add 10 mL of water and repeat steps 2 and 3 using the same oral dosing syringe

     

    Guidance on how to take REVOLADE PfOS is also available to patients and carers:  

    Download patient leaflet

    The REVOLADE platelet response you can count on, now available for more patients

     

    AE, adverse event; AST, aspartate aminotransferase; ITP, immune thrombocytopenia; PfOS, powder for oral suspension.

    References:

    1. REVOLADE PfOS Summary of Product Characteristics.
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    UK | June 2021 | 125357
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    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
    If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]