Prescribing information


REVOLADE has helped change the face of immune thrombocytopenia (ITP) with continued commitment to improving patients’ lives1–8

Since approval, REVOLADE has made a positive difference in the lives of patients with ITP, by not only showing continuous improvements in platelet counts,6,7,9–11 but also by demonstrating significant improvements in quality of life (QoL)6


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Been licensed for ITP treatment for over a decade1,2

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Accumulated 270,623 patient-years of experience across all indications12*

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Demonstrated maintained platelet counts over 7 years of treatment1,2,7‡

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A heritage of providing patients with ITP with a rapid and sustained response with an established safety and tolerability profile6,7,9–11

Over a decade of REVOLADE



Trust REVOLADE for a Targeted, Tailored, and Tested treatment with the aim to improve ITP patients’ lives

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Building a heritage in ITP for patients

EC, European Commission; HCP, healthcare professional; ITP, immune thrombocytopenia; I-WISh, ITP World Impact Survey; QoL, quality of life.

*Therapeutic indications: 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).1,2

The cumulative post-marketing exposure is estimated to be 270,623 patient-years since the international birth date in October of 2004.12

REVOLADE was administered to 302 patients. Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years of treatment were 85,000/μL (n=218), 85,000/μL (n=180), 105,000/μL (n=107), 64,000/μL (n=75), 75,000/μL (n=34), 119,000/μL (n=18) and 76,000/μL, respectively.1,2

§The RAISE study was a phase III, double-blind, placebo-controlled study (N=197) which evaluated the response of ITP patients (defined as a platelet count of 50,000–400,000/μL) to REVOLADE over 6 months of treatment.6

**The REPEAT study was a phase II, open-label, single-arm study (N=66) which evaluated the safety and consistency of response in ITP patients (defined as >6 months duration with baseline platelet counts between 20,000/μL and 50,000/μL) treated with repeated intermittent dosing of REVOLADE across 3 cycles (defined as consisting of an on-therapy period of up to 6 weeks followed by an off-therapy period of up to 4 weeks). Patients who did not respond in Cycle 1 were not eligible to continue the trial.9

††The PETIT study was a three-part randomised, multicentre, placebo-controlled study (N=67) which assessed efficacy and safety of REVOLADE in children aged 1–17 years with chronic ITP (defined as >6 months duration and platelet counts <30,000/μL). Because the study was the first to evaluate REVOLADE use in children, an initial open-label, dose-finding phase was conducted. The double-blind phase and open-label phase of the study recruited additional patients who had not participated in the dose-finding phase.10

‡‡The PETIT2 study was a two-part randomised, multicentre, placebo-controlled study (N=92) which assessed efficacy and safety of REVOLADE in children aged 1–17 years with chronic ITP (defined as >12 months duration and platelet counts <30,000/μL). Starting doses for REVOLADE were based on results from the open-label, dose-finding phase of the PETIT study.11

§§The EXTEND study was a phase III, open-label study (N=302) which evaluated long-term safety and efficacy of REVOLADE in adults with ITP (defined as >6 months duration with baseline platelet counts <30,000/μL) who have completed a previous REVOLADE study. The study reviewed more than 8 years of continuous treatment; 302 patients were enrolled and 135 (45%) completed the study, 60% were treated for at least 2 years and 35% at least 3 years.7



  1. REVOLADE FCT Summary of Product Characteristics.
  2. REVOLADE PfOS Summary of Product Characteristics.
  3. Novartis. Patient resources. ITP Pocket Log. 2021. Available at: https://w​​atient-resources#pocket-log-app.
  4. Novartis. Patient resources. 2021. Available at: https://w​​patient-resources.
  5. Data on file I-WISh Global Survey Report 2018.
  6. Cheng G, et al. Lancet. 2011;377:393–402.
  7. Wong R, et al. Blood. 2017;130:2527–2536.
  8. Khelif A, et al. Am J Hematol. 2019;94:200–208.
  9. Bussel J, et al. Br J Haematol. 2013;160:538–546.
  10. Bussel J, et al. Lancet. 2015;2:315–325.
  11. Grainger J, et al. Lancet. 2015;386:1649–1658.
  12. Data on file REVDOFPATIENTYEARS.
  13. Bussel J, et al. N Engl J Med. 2007;357:2237–2247.
  14. REVOLADE EPAR Authorisation for Paediatric Patients 2016. Available at: https://w​​-investigationplans/emea-000170-pip01-07-m04.
  15. REVOLADE EPAR Variation Assessment Report 2015. Available at: https://w​​-report/revolade-h-c-1110-ii-0020-epar-assessment-report-variation_en.pdf.
  16. REVOLADE EPAR Assessment Report 2019. Available at: https://w​​-report/revolade-h-c-1110-ii-0050-eparassessment-report-variation_en.pdf.
  17. NHS Specialist Pharmacy Service. Eltrombopag dm+d. Available at: https://w​​rombopag/.
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UK | February 2022 | 170960

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