Prescribing information

 

   

REVOLADE HAS AN ESTABLISHED SAFETY PROFILE IN CHILD AND ADULT ITP PATIENTS1–5

REVOLADE is an established ITP medication, having been approved since 2010 with 8 years of clinical exposure across 5 clinical trials (EXTEND, RAISE, REPEAT, PETIT and PETIT2).1–5

Stethoscope, Thumbs up and Patience icons

THE EXTEND STUDY1 

The long-term EXTEND study is a clinical trial that examined the safety and tolerability of REVOLADE:

  • No new safety findings were observed in >300 patients treated with REVOLADE, lasting up to 8.76 years
  • After 250 weeks of treatment, 15 of the original 302 patients were still on REVOLADE
  • 92% of patients (n=277/302) experienced at least one AE of any grade. Of which, most were mild-moderate (Grade 1–2)
  • The most frequent AEs were headache (28%), common cold (25%), and upper respiratory tract infection (23%)
  • The most common serious AEs were cataracts (5%), pneumonia (3%), anaemia (2%) and ALT increase (2%)
Bar chart  showing adverse events occurring in >10% of patients
 

 Bar chart showing the number of AEs experienced with REVOLADE vs placebo

THE RAISE STUDY2

  • During the RAISE study, REVOLADE was generally well-tolerated
  • Of the 197 patients enrolled, grade 3 or 4 AEs were experienced by 15% of patients (n=20/135) treated with REVOLADE, compared with 11% of patients (n=7/61) treated with placebo
  • On-treatment serious bleeding (a serious AE) was significantly lower in patients receiving REVOLADE (n=1/135, <1%) compared with placebo (n=4/61, 7%; p=0.03)
 

Abbreviations: AE, adverse event; ALT, alanine transaminase; ITP, immune thrombocytopenia.

References

  1. Wong RSM, et al. Blood. 2017;130(23):2527–2536.
  2. Cheng G, et al. Lancet. 2011;377:393–402.
  3. Bussel JB, et al. Br J Haematol. 2013;160:538–546.
  4. Bussel JB, et al. Lancet Haematol. 2015;2(8):e315–325.
  5. Grainger JD, et al. Lancet. 2015;386(10004):1649–1658.
HCP19-C002j(1) June 2020.

For more information, refer to the REVOLADE® (eltrombopag olamine) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/7819/smpc

Legal Category: POM.

Aluminium blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets. Marketing Authorisation (MA) number, quantities and NHS price: EU/1/10/612/002 – 25 mg x 28 tablet pack £770, EU/1/10/612/005 – 50 mg x 28 tablet pack £1540, EU/1/10/612/008 – 75 mg x 28 tablet pack £2310

 

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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]