Revolade

eltrombopag

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This is a summary of the European public assessment report (EPAR) for Revolade. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Revolade.

For practical information about using Revolade, patients should read the package leaflet or contact their doctor or pharmacist.

What is Revolade and what is it used for?

Revolade is a medicine that is used for the treatment of:

  • long-term immune (idiopathic) thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys the platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts in the blood (thrombocytopenia) and are at risk of bleeding. Revolade is used in patients aged 1 year and above who do not respond to treatment with medicines such as corticosteroids or immunoglobulins;
  • thrombocytopenia in adult patients with chronic (long-term) hepatitis C, a disease of the liver caused by infection with the hepatitis C virus, when the severity of thrombocytopenia is preventing antiviral therapy;
  • acquired severe aplastic anaemia (a disease in which the bone marrow does not make enough blood cells or platelets) in adult patients. Revolade is used in patients who did not respond to or had received multiple courses of immunosuppressive therapy (medicines that lower the body’s immune defences) and cannot receive haematopoietic (blood) stem cell transplantation.

Revolade contains the active substance eltrombopag.

How is Revolade used?

Revolade is available as tablets (12.5, 25, 50 and 75 mg) and as a powder (25 mg) to prepare a suspension (a liquid to be taken by mouth). The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating blood diseases or chronic hepatitis C and its complications.

The dose depends on the patient’s age and the disease Revolade is being used to treat; it is adjusted as needed to maintain the appropriate platelet level. For ITP and aplastic anaemia, a lower starting dose may be needed in patients of East Asian descent (such as Chinese, Japanese, Korean or Taiwanese).

Patients should not take any antacids, dairy products or mineral supplements in the four hours before and in the two hours after taking Revolade. For more information, see the package leaflet.

How does Revolade work?

In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets by attaching to certain targets in the bone marrow. The active substance in Revolade, eltrombopag, attaches to and stimulates the same receptors as thrombopoietin. This leads to an increased production of platelets, improving platelet counts.

What benefits of Revolade have been shown in studies?

For the treatment of chronic ITP in adults, Revolade was compared with placebo (a dummy treatment) in two main studies involving a total of 311 patients who had previously been treated, but the treatments had not worked or the disease had come back.

Revolade was shown to be more effective than placebo: in the first study, 59% of the patients who took Revolade (43 out of 73) achieved a platelet count of at least 50,000 per microlitre (a platelet level considered adequate to prevent the risk of bleeding complications) after six weeks (the main measure of effectiveness), compared with 16% of those who took placebo (6 out of 37). In the second study, patients taking Revolade were around eight times more likely than those taking placebo to reach the target platelet count of between 50,000 and 400,000 per microlitre during the six months of treatment.

In children with chronic ITP, Revolade was shown to be more effective than placebo in one main study involving a total of 92 children between 1 and 17 years of age who had previously received treatment for ITP. This study lasted 13 weeks and looked at the proportion of patients whose platelet count had increased to at least 50,000 per microlitre for at least 6 out of 8 weeks, between week 5 to 12 of the study in the absence of rescue medication. This occurred in around 40% of those taking Revolade (25 out of 63) compared with around 3% (1 out of 29) of those who took placebo. The study had also an extension phase, in which all patients received Revolade. This showed that Revolade was also effective at maintaining adequate levels of platelets in the long term.

For the treatment of thrombocytopenia associated with hepatitis C, two main studies involving a total of 1,441 adults were carried out. These compared Revolade with placebo for allowing the starting and maintenance of antiviral treatment in patients with hepatitis C whose platelet count was initially too low to allow starting such treatment (less than 75,000 per microlitre). In both studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 6 months after the end of treatment.

In these two studies, a higher proportion of patients who took Revolade tested negative for hepatitis C, compared with those who took placebo (23% versus 14% in the first study, and 19% versus 13% in the second study).

For the treatment of severe aplastic anaemia, Revolade was studied in 43 patients and it was not compared with any other medicine. The main measure of effectiveness was the number of patients who responded to Revolade (whose platelet, red or white blood cell count remained above pre-set levels) after 12 or 16 weeks of treatment.

In this study, 40% of patients (17 out of 43) responded to treatment after 12 weeks, and 65% of responders (11 out of 17) either had a platelet count increase of at least 20,000 per microliter or had a platelet count that was stable without need for blood transfusions. Preliminary data from a supportive study are consistent with the result of the main study, with 46% of patients responding to treatment after 12 weeks.

What are the risks associated with Revolade?

The most common side effects with Revolade in adults with chronic ITP and hepatitis C (seen in more than 1 patient in 10) are headache, anaemia (low red blood cell counts), decreased appetite, insomnia (difficulty sleeping), cough, nausea (feeling sick), diarrhoea, pruritus (itching), alopecia (hair loss), myalgia (muscle pain), pyrexia (fever), fatigue (tiredness), influenza (flu)-like illness, asthenia (weakness), chills and peripheral oedema (swelling, especially of the ankles and feet). In addition, in children with ITP the most common side effects also included colds, nasopharyngitis (inflammation of the nose and throat), rhinitis (inflammation of the lining of the nose), pain in the belly or in the mouth and throat, toothache, rash, runny nose and abnormal blood levels of certain liver enzymes (AST).

In adults with severe aplastic anaemia the most common side effects included headache, dizziness, insomnia, cough, dyspnoea (difficulty breathing), pain in the belly or in the mouth and throat, nausea, diarrhoea, joint pain, muscle spasms, pain in limbs, fatigue, fever, ecchymosis (discoloration of the skin resulting from bleeding underneath), abnormal blood levels of certain liver enzymes and runny nose.

In patients with thrombocytopenia and advanced chronic hepatitis C who are treated with a medicine called interferon and Revolade liver problems and thromboembolic complications (problems with clots in blood vessels) are the most important serious side effects. In these patients Revolade should only be used if clinically indicated and patients should then be closely monitored. Bleeding can also come back after the medicine is stopped.

For the full list of restrictions and side effects with Revolade, see the package leaflet.

Why has Revolade been approved?

The European Medicines Agency decided that Revolade’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Revolade?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revolade have been included in the summary of product characteristics and the package leaflet.

Other information about Revolade

The European Commission granted a marketing authorisation valid throughout the European Union for Revolade on 11 March 2010.

For more information about treatment with Revolade, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Revolade : EPAR - Summary for the public BG = bălgarski 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public ES = español 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public CS = čeština 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public DA = dansk 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public DE = Deutsch 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public ET = eesti keel 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public EL = elliniká 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public EN = English 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public FR = français 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public IT = italiano 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public LV = latviešu valoda 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public LT = lietuvių kalba 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public HU = magyar 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public MT = Malti 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public NL = Nederlands 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public PL = polski 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public PT = português 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public RO = română 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public SK = slovenčina 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public SL = slovenščina 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public FI = suomi 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public SV = svenska 2010-04-29 2017-08-23
Revolade : EPAR - Summary for the public HR = Hrvatski 2010-04-29 2017-08-23

This EPAR was last updated on 23/08/2017 .

Authorisation details

Product details

Product details for Revolade
NameRevolade
Agency product numberEMEA/H/C/001110
Active substance

eltrombopag olamine

International non-proprietary name (INN) or common name

eltrombopag

Therapeutic area Purpura, Thrombocytopenic, Idiopathic
Anatomical therapeutic chemical (ATC) code B02BX05

Publication details

Publication details for Revolade
Marketing-authorisation holder

Novartis Europharm Limited

Revision18
Date of issue of marketing authorisation valid throughout the European Union11/03/2010

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

19/07/2017  Revolade -EMEA/H/C/001110 -PSUSA/00001205/201609

Name Language First published Last updated
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23
Revolade : EPAR - Product Information HR = Hrvatski 2010-04-29 2017-08-23

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20
Revolade : EPAR - All Authorised presentations HR = Hrvatski 2010-04-29 2016-04-20

Name Language First published Last updated
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07
Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-04-29 2011-06-07

Pharmacotherapeutic group

Antihaemorrhagics

Therapeutic indication

Revolade is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).

Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).

Assessment History

Authorised

This medicine is approved for use in the European Union

More information on Revolade

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 3 August 2007. Upon request of the marketing-authorisation holder, Revolade has now been removed from the Community register of orphan medicinal products.