Prescribing information

   

Dosing guidance

 

REVOLADE offers patients convenience and flexibility1,2

REVOLADE is a once-daily (OD) oral thrombopoietin receptor agonist (TPO-RA) offering the convenience of injection-free treatment with flexible dosing1,2

REVOLADE can be taken with a meal low in calcium (≤50 mg) or on its own, 2 hours before or 4 hours after products containing polyvalent cations (e.g. calcium-containing dairy products and mineral supplements)1,2

Flow chart showing REVOLADE dosing with knife and fork icon in the middle

 Small icon of man running fast for description of Treatment initiation for REVOLADE

  • Adults and paediatric patients aged 6–17 years:
    • The recommended starting dose is 50 mg OD; for patients of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), REVOLADE should be initiated at a reduced dose of 25 mg OD
  • Paediatric patients aged 1–5 years:
    • The recommended starting dose is 25 mg OD

Small icon of tablet jar and tablets for description of Dose adjustments.

  • Dose adjustment should be made to achieve and maintain a platelet count ≥50,000/μl to reduce the risk of bleeding
  • Titrate REVOLADE dosage based on patient’s platelet count
  • A daily dose of 75 mg must not be exceeded
Under Dose adjustments, 4 small arrow and hand icons to show an increase by 25 mg/day to a maximum of 75 mg/day  for platelets <50,000 /microlitre (upward arrows);

Increase by 25 mg/day to a maximum of 75 mg/day

Under Dose adjustments, 4 small arrow and hand icons to show Maintain lowest dose of REVOLADE and/or concomitant ITP treatment for platelets of 50 to 100,000 / microlitre (right-hand arrows);

Maintain lowest dose of REVOLADE and/or concomitant ITP treatment

Under Dose adjustments, 4 small arrow and hand icons to show Decrease by 25 mg/day to maintain platelet counts that avoid or reduce bleeding for platelet count of 100,000 to 150,000 /microlitre (downward arrows);

Decrease by 25 mg/day to maintain platelet counts that avoid or reduce bleeding

 Under Dose adjustments, 4 small arrow and hand icons to show Stop REVOLADE and increase frequency of platelet monitoring to twice weekly for platelet count of more than 150,000 / microlitre.

Stop REVOLADE and increase frequency of platelet monitoring to twice weekly

 

Small icon of disrupted infinity symbol for description of 'Discontinuation'.

  • REVOLADE should be discontinued if platelet counts do not increase to a level sufficient to avoid clinically significant bleeding after 4 weeks of therapy at 75 mg OD
  • Patients should be clinically evaluated periodically, and continuation of treatment should be decided on an individual basis by the treating physician. In non-splenectomised patients this should include evaluation relative to splenectomy
  • Relapse is possible upon discontinuation of treatment 

Count on REVOLADE for a conventient and flexible ITP treatment

 

FCT, film coated tablet; ITP; immune thrombocytopenia; OD, once daily; PfOS, powder for oral suspension.

References:

  1. REVOLADE FCT Summary of Product Characteristics.
  2. REVOLADE PfOS Summary of Product Characteristics.
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UK | June 2021 | 125355
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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]