Prescribing information

   

For a trusted response in immune thrombocytopenia (ITP) patients

 

ITP patients can feel frustrated with their symptoms, often experiencing long periods of uncertainty and anxiety with delays to diagnosis and several, often-unsuccessful rounds of treatments.1–3 However, REVOLADE can offer your ITP patients rapid and sustained improvements that could help to alleviate disease burden4–6

The International Consensus Report (ICR) recommends a patient-centric approach through the following treatment goals:7

Arrows moving round in a circle with 2 blood droplets in the middle for 'Prevent severe bleeding episodes'

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Prevent severe
bleeding episodes

Person standing on mound holding a flag for 'Optimise health-related quality of life (HRQoL)';

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Optimise health-related
quality of life (HRQoL)

Tablet jar with 2 loose tablets for 'Provide treatment with minimal toxicity';

green line separator

Provide treatment
with minimal toxicity

floating platelets for 'Maintain a platelet count of >20,000–30,000/μL for symptomatic patients'.

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Maintain a platelet count of >20,000–30,000/μL for symptomatic patients

 

REVOLADE can help your ITP patients achieve these goals through responses that are:4,5

Platelet counts doubled as early as Week 15*

  • REVOLADE patients see an increase in platelet counts after as little as 1 week of treatment, with median platelet counts doubling from 16,000/μL to 36,000/μL
  • After 2 weeks of treatment with REVOLADE, median platelet counts increased to between 53,000/μL and 73,500/μL
  • REVOLADE is also able to offer patients rapid relief from bleeding symptoms, with a ~50% reduction in the rate of clinically significant bleeding as early as Day 15

 

Median platelet counts of REVOLADE patients across 26 weeks of treatment5

Line graph to show median platelet counts of REVOLADE patients across 26 weeks of treatment.

What can a rapid response mean to your ITP patients?

Improvements in platelet counts for 80% of patients4‡

  • Majority of REVOLADE patients (80%) are able to achieve a platelet count 50,000/μL, regardless of baseline platelet count [<30,000/μL, 81.5% (n=172/211); 30–50,000/μL, 98.1% (n=51/52); >50,000/μL, 92.3% (n=36/39)] or splenectomy status [splenectomised, 80% (n=92/115); non-splenectomised, 89.3% (n=167/187)]
  • For 31 weeks, most (51%, n=126/248) REVOLADE patients are able to maintain platelet counts 50,000/μL; the majority of REVOLADE patients (55%, n=108/198) are also able to maintain platelet counts 30,000/μL for ≥91 consecutive weeks

 

REVOLADE patients achieving continuous platelet counts over >104 weeks of treatment4

Histogram to show REVOLADE patients achieving continuous platelet counts over >104 weeks of treatment.

What can a consistent response mean to your ITP patients?

Thrombopoietin receptor agonists recommended for durable platelet responses8

  • In the long-term EXTEND study,* median platelet counts were maintained at 50,000/μL for over 4.5 years4
  • In addition to this, it has been shown that most patients can achieve a durable response with REVOLADE regardless of splenectomy status; 51% (n=19/37) of splenectomised and 66% (n=38/58) of non-splenectomised patients maintaining increased platelet counts5‡

 

REVOLADE patients’ platelet counts over 7 years of treatment4,9

Line graph to show REVOLADE patients’ platelet counts over 7 years of treatment.

What can a durable response mean to your ITP patients?

For more information about the clinical trials, visit the study design page

Read more

 

TRUST REVOLADE to achieve the platelet response your patients can count on

 

FCT, film-coated tablet; HRQoL, health-related quality of life; ICR, International Consensus Report; ITP, immune thrombocytopenia; WHO, World Health Organization.

*The phase III, open-label EXTEND study 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 patient were enrolled and 135 (45%) completed the study, 60% were treated for at least 2 years and 35% at least 3 years.4

Clinically significant bleeding defined as WHO grades 2–4 (grade 0, no bleeding; grade 1, petechiae; grade 2, mild blood loss; grade 3, gross blood loss; grade 4, debilitating blood loss).5
The phase III, double-blind, placebo-controlled RAISE study evaluated the response of ITP patients (defined as >6 months duration with baseline platelet counts <30,000/μL ) to REVOLADE over 6 months of treatment.5

References:

  1. Cooper N, et al. Burden of Disease in Immune Thrombocytopenia (ITP): The results for UK patients from the ITP World Impact Survey (I-WISh). Poster presented at the British Haematology Society Annual Meeting April 16–18, 2018. Liverpool. PO-022.
  2. Cooper N, et al. Am J Hematol. 2021;96:188–198.
  3. McCrae K. Cleve Clin J Med. 2011;78:358–373.
  4. Wong R, et al. Blood. 2017;130:2527–2536.
  5. Cheng G, et al. Lancet. 2011;377:393–402.
  6. Mathias S, et al. Health Qual Life Outcomes. 2008;6:13.
  7. Provan D, et al. Blood Adv. 2019;3:3780–3817.
  8. Neunert C, et al. Blood Adv. 2019;3:3829–3866.
  9. REVOLADE FCT Summary of Product Characteristics.
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UK | June 2021 | 125337
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