Adempas

riociguat

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This is a summary of the European public assessment report (EPAR) for Adempas. 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 Adempas.

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

What is Adempas and what is it used for?

Adempas is a medicine that contains the active substance riociguat. It is used to increase the ability to carry out physical activity in adults with the following forms of pulmonary hypertension (high blood pressure in the blood vessels of the lungs):

  • Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots). Adempas is used to treat patients with CTEPH who cannot be operated on, or in whom CTEPH remains or returns after surgery.
  • Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed). Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists’.

Adempas is used in patients with functional class II to III CTEPH or PAH. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity while ‘class III’ involves marked limitation of physical activity.

Because the number of patients with CTEPH or with PAH is low, the diseases are considered ‘rare’, and Adempas was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 December 2007.

How is Adempas used?

Adempas can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of CTEPH or PAH.

Adempas is available as tablets (0.5, 1, 1.5, 2 and 2.5 mg). The recommended starting dose is 1 mg three times a day (approximately 6 to 8 hours apart) for two weeks. The dose is then increased every two weeks until the appropriate dose for the individual patient is established. The maximum dose should not exceed 2.5 mg three times a day. Treatment with the established dose should continue unless patients experience signs and symptoms of low blood pressure, in which case the dose should be reduced.

For further information, see the package leaflet.

How does Adempas work?

CTEPH and PAH are debilitating diseases where there is severe narrowing of the blood vessels of the lungs. This causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the blood flow to the lungs. As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.

The active substance in Adempas, riociguat, stimulates an enzyme called ‘soluble guanylate cyclase’ in the blood vessels of the lungs, which causes the blood vessels to relax and widen. This helps to lower the blood pressure in the lungs and improve symptoms of CTEPH and PAH.

What benefits of Adempas have been shown in studies?

Adempas has been shown to be effective at improving the distance patients with CTEPH or PAH could walk in six minutes (a way of measuring exercise capacity):

  • Adempas was compared with placebo (a dummy treatment) in one main study in 262 patients with CTEPH who could not be operated, or in whom CTEPH remained or returned after surgery. Before treatment, the patients could walk an average of 347 metres in six minutes. After 16 weeks, patients treated with Adempas could walk on average 46 metres further in six minutes than patients taking placebo.
  • The medicine was also compared with placebo in another main study in 445 patients with PAH. Before treatment the patients could walk an average of 363 metres in six minutes. After 12 weeks, patients treated with Adempas could walk 36 metres further in six minutes than patients taking placebo.
What are the risks associated with Adempas?

The most common side effects with Adempas (which may affect more than 1 in 10 people) are headache, dizziness, dyspepsia (heartburn), peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), diarrhoea and vomiting. Serious side effects include haemoptysis (coughing up blood) and pulmonary haemorrhage (bleeding in the lungs). For the full list of all side effects reported with Adempas, see the package leaflet.

Adempas must not be used in patients with severely reduced liver function, with systolic blood pressure (blood pressure when the heart is contracting) below 95 mmHg before starting treatment, or during pregnancy. It must also not be used together with medicines called ‘PDE 5 inhibitors’ (a class of medicines used for PAH or erectile dysfunction) or with nitrates or nitric oxide donors (often used to treat high blood pressure, chest pain and heart disease, or as recreational drugs). For the full list of restrictions, see the package leaflet.

Why is Adempas approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Adempas’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH. It also noted that no other medicines have been authorised for CTEPH. Regarding safety, the Committee considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan.

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

A risk management plan has been developed to ensure that Adempas is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adempas, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Adempas

The European Commission granted a marketing authorisation valid throughout the European Union for Adempas on 27 March 2014.

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

Name Language First published Last updated
Adempas : EPAR - Summary for the public BG = bălgarski 10/04/2014  
Adempas : EPAR - Summary for the public ES = español 10/04/2014  
Adempas : EPAR - Summary for the public CS = čeština 10/04/2014  
Adempas : EPAR - Summary for the public DA = dansk 10/04/2014  
Adempas : EPAR - Summary for the public DE = Deutsch 10/04/2014  
Adempas : EPAR - Summary for the public ET = eesti keel 10/04/2014  
Adempas : EPAR - Summary for the public EL = elliniká 10/04/2014  
Adempas : EPAR - Summary for the public EN = English 10/04/2014  
Adempas : EPAR - Summary for the public FR = français 10/04/2014  
Adempas : EPAR - Summary for the public IT = italiano 10/04/2014  
Adempas : EPAR - Summary for the public LV = latviešu valoda 10/04/2014  
Adempas : EPAR - Summary for the public LT = lietuvių kalba 10/04/2014  
Adempas : EPAR - Summary for the public HU = magyar 10/04/2014  
Adempas : EPAR - Summary for the public MT = Malti 10/04/2014  
Adempas : EPAR - Summary for the public NL = Nederlands 10/04/2014  
Adempas : EPAR - Summary for the public PL = polski 10/04/2014  
Adempas : EPAR - Summary for the public PT = português 10/04/2014  
Adempas : EPAR - Summary for the public RO = română 10/04/2014  
Adempas : EPAR - Summary for the public SK = slovenčina 10/04/2014  
Adempas : EPAR - Summary for the public SL = slovenščina 10/04/2014  
Adempas : EPAR - Summary for the public FI = suomi 10/04/2014  
Adempas : EPAR - Summary for the public SV = svenska 10/04/2014  
Adempas : EPAR - Summary for the public HR = Hrvatski 10/04/2014  
Name Language First published Last updated
Adempas : EPAR - Risk-management-plan summary (English only) 10/04/2014 13/05/2014

This EPAR was last updated on 10/04/2014 .

Authorisation details

Product details

Product details for Adempas
NameAdempas
Agency product numberEMEA/H/C/002737
Active substance

riociguat

International non-proprietary name (INN) or common name

riociguat

Therapeutic area Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code C02KX05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Adempas
Marketing-authorisation holder

Bayer Pharma AG

Revision0
Date of issue of marketing authorisation valid throughout the European Union27/03/2014

Contact address:

Bayer Pharma AG
Muellerstrasse 178 
13353 Berlin 
Germany

Product information

Product information

27/03/2014  Adempas -EMEA/H/C/002737 --

Name Language First published Last updated
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  
Adempas : EPAR - Product Information EN = English 10/04/2014  

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
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  
Adempas : EPAR - All Authorised presentations EN = English 10/04/2014  

Pharmacotherapeutic group

Antihypertensives for pulmonary arterial hypertension

Therapeutic indication

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with

  • inoperable CTEPH,
  • persistent or recurrent CTEPH after surgical treatment,
  • to improve exercise capacity (see section 5.1). Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).

    Assessment History

    Changes since initial authorisation of medicine

    Name Language First published Last updated

    Initial marketing-authorisation documents

    Name Language First published Last updated
    Adempas : EPAR - Public assessment report EN = English 10/04/2014  
    CHMP summary of positive opinion for Adempas EN = English 24/01/2014  

    Authorised

    This medicine is approved for use in the European Union

    Related information