Opsumit

macitentan

  • Email
  • Help

About

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

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

What is Opsumit and what is it used for?

Opsumit is a medicine that contains the active substance macitentan. It is used for the long-term treatment of pulmonary arterial hypertension (PAH), a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.

Opsumit is used for adults whose PAH is classified as ‘WHO functional class II to class III’. The ‘class’ reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity. Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet.

Because the number of patients with PAH is low, the disease is considered ‘rare’, and Opsumit was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 September 2011.

How is Opsumit used?

Opsumit can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in treating PAH. The medicine is available as 10 mg tablets and taken at a dose of one tablet every day.

How does Opsumit work?

In PAH there is severe narrowing of the arteries of the lungs. Because more pressure is needed to force blood through the narrowed artery, this leads to high blood pressure in the lungs.

The active substance in Opsumit, macitentan, works by blocking ‘endothelin receptors’. These are part of a natural mechanism in the body that can cause arteries to narrow. In patients with PAH, this mechanism is overactive and, by blocking the receptors, macitentan helps widen the arteries in the lungs and thereby bring down the blood pressure.

What benefits of Opsumit have been shown in studies?

In a main study involving 742 patients, Opsumit has been shown to reduce the risk of PAH-related illness, particularly the worsening of PAH symptoms. Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years. Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg.

What are the risks associated with Opsumit?

The most common side effects with Opsumit (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), bronchitis (inflammation of the airways in the lungs), anaemia (low red blood cell counts) and headache. Most side effects are mild to moderate in severity. For the full list of all side effects reported with Opsumit, see the package leaflet.

In animal studies, Opsumit was shown to have an adverse effect on the development of embryos. Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception. Women should also not become pregnant for one month after stopping treatment.

It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood. For the full list of restrictions, see the package leaflet.

Why is Opsumit approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Opsumit’s benefits are greater than its risks and recommended that it be approved for use in the EU. Opsumit had been shown to be effective in reducing illness or deaths due to PAH and the side effects reported were similar to those reported with other medicines of its class and were considered to be manageable. However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.

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

A risk management plan has been developed to ensure that Opsumit 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 Opsumit, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit. Patients’ reminder cards will warn that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests.

Other information about Opsumit

The European Commission granted a marketing authorisation valid throughout the European Union for Opsumit on 20 December 2013.

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

Name Language First published Last updated
Opsumit : EPAR - Summary for the public BG = bălgarski 07/02/2014  
Opsumit : EPAR - Summary for the public ES = español 07/02/2014  
Opsumit : EPAR - Summary for the public CS = čeština 07/02/2014  
Opsumit : EPAR - Summary for the public DA = dansk 07/02/2014  
Opsumit : EPAR - Summary for the public DE = Deutsch 07/02/2014  
Opsumit : EPAR - Summary for the public ET = eesti keel 07/02/2014  
Opsumit : EPAR - Summary for the public EL = elliniká 07/02/2014  
Opsumit : EPAR - Summary for the public EN = English 07/02/2014  
Opsumit : EPAR - Summary for the public FR = français 07/02/2014  
Opsumit : EPAR - Summary for the public IT = italiano 07/02/2014  
Opsumit : EPAR - Summary for the public LV = latviešu valoda 07/02/2014  
Opsumit : EPAR - Summary for the public LT = lietuvių kalba 07/02/2014  
Opsumit : EPAR - Summary for the public HU = magyar 07/02/2014  
Opsumit : EPAR - Summary for the public MT = Malti 07/02/2014  
Opsumit : EPAR - Summary for the public NL = Nederlands 07/02/2014  
Opsumit : EPAR - Summary for the public PL = polski 07/02/2014  
Opsumit : EPAR - Summary for the public PT = português 07/02/2014  
Opsumit : EPAR - Summary for the public RO = română 07/02/2014  
Opsumit : EPAR - Summary for the public SK = slovenčina 07/02/2014  
Opsumit : EPAR - Summary for the public SL = slovenščina 07/02/2014  
Opsumit : EPAR - Summary for the public FI = suomi 07/02/2014  
Opsumit : EPAR - Summary for the public SV = svenska 07/02/2014  
Opsumit : EPAR - Summary for the public HR = Hrvatski 07/02/2014  

This EPAR was last updated on 01/09/2016 .

Authorisation details

Product details

Product details for Opsumit
NameOpsumit
Agency product numberEMEA/H/C/002697
Active substance

macitentan

International non-proprietary name (INN) or common name

macitentan

Therapeutic area Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code C02KX04
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 Opsumit
Marketing-authorisation holder

Actelion Registration Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union20/12/2013

Contact address:

Actelion Registration Ltd
Chiswick Tower 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

Product information

Product information

16/08/2016  Opsumit -EMEA/H/C/002697 -IG/0720

Name Language First published Last updated
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016
Opsumit : EPAR - Product Information HR = Hrvatski 07/02/2014 01/09/2016

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
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  
Opsumit : EPAR - All Authorised presentations HR = Hrvatski 07/02/2014  

Name Language First published Last updated
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  
Opsumit : EPAR - Conditions imposed on member states for safe and effective use - Annex related to the Art. 127a HR = Hrvatski 07/02/2014  

Pharmacotherapeutic group

Antihypertensives, Pulmonary

Therapeutic indication

Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.

Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Opsumit : EPAR - Public assessment report HR = Hrvatski 07/02/2014  
CHMP summary of positive opinion for Opsumit HR = Hrvatski 25/10/2013