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

REVOLADE has:

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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

Learn more

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

 

References:

  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​ww.novartis.co.uk/itp-p​atient-resources#pocket-log-app.
  4. Novartis. Patient resources. 2021. Available at: https://w​ww.novartis.co.uk/itp-​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​ww.ema.europa.eu/en/medicines/human/paediatric​-investigationplans/emea-000170-pip01-07-m04.
  15. REVOLADE EPAR Variation Assessment Report 2015. Available at: https://w​ww.ema.europa.eu/en/documents/variation​-report/revolade-h-c-1110-ii-0020-epar-assessment-report-variation_en.pdf.
  16. REVOLADE EPAR Assessment Report 2019. Available at: https://w​ww.ema.europa.eu/en/documents/variation​-report/revolade-h-c-1110-ii-0050-eparassessment-report-variation_en.pdf.
  17. NHS Specialist Pharmacy Service. Eltrombopag dm+d. Available at: https://w​ww.sps.nhs.uk/medicines/elt​rombopag/.
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UK | February 2022 | 170960
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