For Health Care Professionals Outside the US
  • US Residents
  • REVOLADE Product Characteristics
  • Safety Information
REVOLADE® (eltrombopag)
  • Efficacy
    • ITP
      • Adult ITP
      • Paediatric ITP
    • SAA
    • Chronic HCVaT
      • Platelet response
      • Sustained virologic response
    • Study Designs
      • ITP
      • SAA
      • Chronic HCVaT
  • Safety
    • ITP
      • Most common AEs
      • VTE
      • Bone marrow fibrosis
    • SAA
    • HCVaT
  • Patient Experience
    • Patient Preferences
      • Once-daily Oral Therapy
      • REVOLADE to Other TPO-RAs
    • Why choose REVOLADE
      • Corticosteroids
      • Rituximab
      • Splenectomy
      • Other TPO-RAs
  • MOA
    • Complements Endogenous TPO
    • ITP
    • SAA
    • Immunomodulatory Response
  • Dosing & Administration
    • Dosing and administration
      • Dosing
      • Dietary guidelines
    • Dosing flexibility

Why choose REVOLADE over other therapies for immune thrombocytopenia (ITP)?

Corticosteroids May Add to
Patients’ Disease Burden

Corticosteroid therapy fails to deliver sustained benefits in the majority of patients1

85% of patients who initially respond to corticosteroids will lose response 85% of patients who initially respond to corticosteroids will lose response
  • Despite an initial response to corticosteroids, only 15% of patients maintain a response beyond 6 to 12 months after initial response1

Corticosteroid use may rapidly lead to side effects and significant complications that, in time, may outweigh the benefits2

Corticosteroid use may rapidly lead to side effects Corticosteroid use may rapidly lead to side effects
  • Prolonged corticosteroid use is not advisable1,2
    • Prednisone needs to be rapidly tapered and usually stopped in responders, and especially in nonresponders after 4 weeks
69% of patients would avoid corticosteroids whenever possible 69% of patients would avoid corticosteroids whenever possible
REVOLADE has a proven long-term safety profile in the treatment of ITP4-7
Review the data

Why choose REVOLADE over other therapies for ITP?

Rituximab Is Not Licensed
For the Treatment of ITP in Any Country

Rituximab offers no benefit over placebo8

  • Results through Week 78 of the only randomised, double-blind study of rituximab for the treatment of ITP8
Rituximab and placebo had similar rates of treatment failure in a double-blind ITP study Rituximab and placebo had similar rates of treatment failure in a double-blind ITP study

Treatment failure was defined as requiring a splenectomy or meeting the criteria for a splenectomy after Week 12 (in cases where splenectomy was not performed because it was contraindicated or because of patient’s refusal).8

Rituximab offered no benefit over placebo in a double-blind ITP study Rituximab offered no benefit over placebo in a double-blind ITP study

†Complete response was defined as a platelet count ≥100 x 109/L.8

‡Overall response was defined as a platelet count ≥30 x 109/L.8

Rituximab fails to provide long-term control9
21% of patients obtained long-term response with rituximab 21% of patients obtained long-term response with rituximab

Response was defined as platelet count ≥50 x 109/L.9

  • Only 21% of patients achieved long-term response with rituximab9
REVOLADE provides proven and trusted platelet control for patients with ITP.5,6
Review the data

Why choose REVOLADE over other therapies for ITP?

Splenectomy Is an Invasive, Irreversible Procedure
That May Provide No Benefit

Many patients fail to respond adequately after a splenectomy2

Many patients fail to respond adequately after a splenectomy Many patients fail to respond adequately after a splenectomy
  • Invasive procedures such as splenectomy require inpatient admission, general anaesthesia, and a lifetime of regular follow-up2,10
    • This may include annual platelet count, repeated immunisations, and daily antibiotics
  • Complication rates from splenectomy can be up to 12.9% with laparotomy and 9.6% with laparoscopy, as seen in a systematic literature review2

Complications of splenectomy2

Common complications of splenectomy Common complications of splenectomy
Patients often have a negative experience with splenectomy5
Many patients have a negative experience with splenectomy Many patients have a negative experience with splenectomy

These results are based on the responses of 260 patients who participated in a patient and physician survey on ITP conducted in 13 countries.5

  • There is no widely accepted test to predict response to splenectomy2
    • Splenectomy should be reserved for patients with severe ITP, at high risk of bleeding, or who need continuous glucocorticoid therapy11
      • Severe ITP is defined as platelet count <10 x 109/L to 20 x 109/L

Splenectomy puts patients at increased risk of venous thromboembolism (VTE) and infection

Splenectomy increases patients’ risk of VTE Splenectomy increases patients’ risk of VTE

Splenectomy increases patients’ risk of infection and malignancy10,13

Increased risk of infection and malignancy postsplenectomy Increased risk of infection and malignancy postsplenectomy

In a study of 8,149 cancer-free splenectomised patients who were followed for up to 27 years.13

The use of splenectomy in ITP has been declining in the last 20 years12,14

Rates of splenectomy are in decline Rates of splenectomy are in decline

Splenectomy has declined a further 10% since the publication of the 2010 International Consensus report on primary ITP.14

  • Potential reasons for the decline of splenectomy may include12:
    • Physician and patient preference for medical (rather than surgical) therapy
    • Increased awareness of the potential risks associated with the procedure
REVOLADE is proven to provide long-term response, with a higher chance of success when used before splenectomy.6
Review the data

Why choose REVOLADE over other therapies for ITP?

Not All TPO-RAs Offer the
Consistent Control Your Patients Need

Greater fluctuation in platelet counts with romiplostim15

Platelet count fluctuations with romiplostim attenuated after switching to REVOLADE Platelet count fluctuations with romiplostim attenuated after switching to REVOLADE

Data from a retrospective study of TPO-RA switching.15

  • Once-daily oral dosing offers more physiological mimicry than once-weekly subcutaneous administration4,15,16
    • The half-life of REVOLADE (approximately 21-32 hours) relative to dosing frequency (every 24 hours) allows for steady drug levels, mimicking endogenous TPO4,15-17
  • In healthy subjects, TPO is produced constitutively in the liver16
92% of TPO-RA switches due to platelet fluctuations were in patients initially treated with romiplostim 92% of TPO-RA switches due to platelet fluctuations were in patients initially treated with romiplostim
See more data from these studies
REVOLADE has a unique mechanism of action that sets it apart.4,20
Review the data

References:

1. McCrae K. Immune thrombocytopenia: no longer ‘idiopathic’. Cleve Clin J Med. 2011;78(6):358-373. 2. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115(2):168-186. 3. Matzdorff AC, Arnold G, Salama A, Ostermann H, Eberle S, Hummler S. Advances in ITP—therapy and quality of life—a patient survey. PLoS ONE. 2011;6(11):e27350. 4. REVOLADE Summary of Product Characteristics. February 2019. 5. Data on file. 6. Wong RSM, Saleh MN, Khelif A, et al. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017;130(3):2527-2536. 7. Saleh MN, Bussel JB, Cheng G; the EXTEND Study Group. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood. 2013;121(3):537-545. 8. Ghanima W, Khelif A, Waage A, et al; the RITP Study Group. Rituximab as second-line treatment for adult immune thrombocytopenia (the RITP trial): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2015;385(9978):1653-1661. 9. Patel VL, Mahévas M, Lee SY, et al. Outcomes 5 years after response to rituximab therapy in children and adults with immune thrombocytopenia. Blood. 2012;119(25):5989-5995. 10. Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood. 2012;120(5):960-969. 11. Stasi R. Pathophysiology and therapeutic options in primary immune thrombocytopenia. Blood Transfus. 2011;9(3):262-273. 12. Boyle S, White RH, Brunson A, Wun T. Splenectomy and the incidence of venous thromboembolism and sepsis in patients with immune thrombocytopenia. Blood. 2013; 121(23):4782-4790. 13. Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica. 2014;99(2):392-398. 14. Provan D, Newland AC. Current management of primary immune thrombocytopenia. Adv Ther. 2015;32(10):875-887. 15. Khellaf M, Viallard J-F, Hamidou M, et al. A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia. Haematologica. 2013;98(6):881-887. 16. Kuter DJ. The biology of thrombopoietin and thrombopoietin receptor agonists. Int J Hematol. 2013;98(1):10-23. 17. Nplate (romiplostim) Summary of Product Characteristics. Breda, The Netherlands: Amgen Europe BV, 2013. 18. Carpenedo M, Cantoni S, Mazzucconi MG, et al. Sequential use of thrombopoietin receptor agonists in adult primary immune thrombocytopenia patients: a retrospective collaborative survey from Italian hematology centers. Poster presented at: The 22nd European Hematology Association Congress; June 24, 2017; Madrid, Spain. Abstract P722. 19. Lakhwani S, Perera M, Fernández-Fuertes F, et al. Thrombopoietin receptor agonist switch in adult primary immune thrombocytopenia patients: a retrospective collaborative survey involving 4 Spanish centres. Eur J Haematol. 2017;99(4):372-377. 20. Lum SH, Grainger JD. Eltrombopag for the treatment of aplastic anemia: current perspectives. Drug Des Devel Ther. 2016;10:2833-2843.

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Disclaimer: This is an international website for REVOLADE® (eltrombopag) and is intended for health care professionals outside the US. If you are a US resident, please click on the US Residents links at the top of this page. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.
This is an international site for REVOLADE® (eltrombopag) and is intended for health care professionals outside the US.
REVOLADE® (eltrombopag) clinical information
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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC)

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