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Prescribing information

 

REVOLADE® (eltrombopag olamine)

REVOLADE is proven for rapid and consistent response in primary immune thrombocytopenia (ITP).1–3

 

INDICATION

REVOLADE is indicated for the treatment of patients aged 1 year and above with primary ITP lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).2

REVOLADE is indicated in adult patients with chronic HCV infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.2

REVOLADE is indicated in adult patients with acquired SAA who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation.2

 

WHAT IS REVOLADE?

REVOLADE is a once-daily thrombopoietin receptor agonist (TPO-RA). Available in a film-coated tablet formulation, REVOLADE binds to TPO receptors resulting in an increased production of platelets:2

  • REVOLADE can offer CONFIDENCE through consistent response*– 85.8% of ITP patients responded to treatment (n=259/302) in the EXTEND study1,4†
  • REVOLADE can offer CONVENIENT dose adjustment with a flexible 2-step titration2,3
  • REVOLADE can achieve platelet CONTROL without immunosuppression2,5
  • REVOLADE has an established safety profile, with >8 years of clinical experience1,3,6,7
Image of curtain being lifted

REVOLADE helps ITP patients achieve a RAPID, CONSISTENT, DURABLE and REPEATABLE platelet response, reducing the disease burden of ITP.1,3,7

 

*Response was defined as achieving a platelet count of more than 50,000/μL at least once in the absence of rescue therapy.†EXTEND: A phase III open-label extension study in 302 adult patients with ITP.1

Abbreviations: HCV, hepatitis C virus; ITP, immune thrombocytopenia; SAA, severe aplastic anaemia; TPO, thrombopoietin; TPO-RA, thrombopoietin-receptor agonist.

References:

  1. Wong RSM, et al. Blood. 2017;130(23):2527–2536.
  2. REVOLADE Summary of Product Characteristics.
  3. Cheng G, et al. Lancet. 2011;377:393–402.
  4. Data on File, I-WISh – Global Survey Results p. 55 (REVDOF001).
  5. Yazdanbakhsh K. Blood. 2016;128(6):750–751.
  6. Grainger JD, et al. Lancet. 2015;386(10004):1649–1658.
  7. Bussel JB, et al. Br J Haematol. 2013;160:538–546.
HCP19-C002(1) June 2020.
Haematology
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For more information, refer to the REVOLADE® (eltrombopag olamine) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/7819/smpc

Legal Category: POM.

Aluminium blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets. Marketing Authorisation (MA) number, quantities and NHS price: EU/1/10/612/002 – 25 mg x 28 tablet pack £770, EU/1/10/612/005 – 50 mg x 28 tablet pack £1540, EU/1/10/612/008 – 75 mg x 28 tablet pack £2310

 

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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]