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The longest-term safety profile in ITP—studied for up to 8.8 years1-4

Severity of all adverse events was reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 3.0.5

One patient randomised to placebo was excluded from the safety population because no study drug was administered.5

No data available.2

Event typically associated with use of corticosteroids. In RAISE, peripheral oedema occurred at a significantly lower rate with REVOLADE than with placebo (P=0.01).5

Review the RAISE and EXTEND study designs

Most common serious adverse events in the long-term EXTEND study

  • The most frequently reported serious adverse events were cataract (16 patients; 5%) and pneumonia (8 patients; 3%)3
    • Note that some of these patients had prior risk factors for cataract development (eg, corticosteroid use, cigarette use, diabetes mellitus)

Discontinuation due to adverse events in the long-term EXTEND study

  • Forty-one patients (14%) reported an adverse event that led to permanent treatment discontinuation2
    • 5 patients (2%) were withdrawn from the study due to alanine aminotransferase increase, 4 patients (1%) due to bilirubin increase, and 4 patients (1%) due to cataract2,3
  • Withdrawals due to thromboembolic events included 3 patients (<1%) due to deep vein thrombosis and 2 patients (<1%) due to cerebral infarction2
    • Note that these patients had prior risk factors for thromboembolism, and patients with ITP have a higher risk of venous thromboembolism compared with the general population4,6

REVOLADE also has a well-established safety profile in paediatric patients (≥1 year of age) with ITP2,7,8

AST, aspartate aminotransferase.

REVOLADE safety population includes 1 patient randomised to placebo who received REVOLADE.7

Includes 1 Grade 3-4 adverse event.7

No data available.2

Review the PETIT and PETIT 2 study designs
No increased risk of VTE with REVOLADE in the EXTEND study3,6

TEE, thromboembolic event; VTE, venous thromboembolism.

*Includes both VTE and arterial thromboembolism.6

Review the EXTEND study design

With REVOLADE, reticulin deposition is minimal and reversible3

  • The majority of patients remained at an MF score of 0 (87/166, 52%) or had a maximal increase to MF-1 (68/166, 41%)3
    • Ten patients (6%) had a maximal increase to MF-2 and 1 patient (<1%) had a maximal increase to MF-33
  • No on-treatment biopsies were prompted by abnormal cell counts, morphology, or symptoms suggestive of bone marrow dysfunction3
Review the EXTEND study design


1. REVOLADE Summary of Product Characteristics. February 2019. 2. Data on file. 3. 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. 4. 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. 5. Cheng G, Saleh MN, Marcher C, et al. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011;377(9763):393-402. 6. Langeberg WJ, Schoonen WM, Eisen M, Gamelin L, Stryker S. Thromboembolism in patients with immune thrombocytopenia (ITP): a meta-analysis of observational studies. Int J Hematol. 2016;103(6):655-664. 7. Bussel JB, de Miguel PG, Despotovic JD, et al. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015;2(8):e315-e325. 8. Grainger JD, Locatelli F, Chotsampancharoen T, et al. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. Lancet. 2015;386(10004):1649-1658.