Adempas
Authorised
This medicine is authorised for use in the European Union
riociguat
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Adempas is a medicine that is used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs). It is used in the following types of PAH:
• Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots). Adempas is used to treat adult patients with CTEPH who cannot have surgery, 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) in adults and in children weighing more than 50 kg. In adults with PAH, Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists’ whereas in children it is used with 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 a slight limitation of physical activity while ‘class III’ involves a marked limitation of physical activity.
CTEPH and PAH are rare, and Adempas was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 December 2007. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
Adempas contains the active substance riociguat.
Adempas can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of CTEPH or PAH. Adempas is available as tablets. For patients unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft food such as apple sauce.
The usual 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 based on the patients’ systolic blood pressure (blood pressure when the heart is contracting) until the appropriate dose for the individual patient is established. 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 more information about using Adempas, see the package leaflet or contact your healthcare provider.
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, causing the blood vessels to relax and widen. This helps to lower the blood pressure in the lungs and improve symptoms of CTEPH and PAH.
Adempas has been shown to be effective at improving exercise capacity, measured as the distance patients with CTEPH or PAH could walk in 6 minutes:
• Adempas was compared with placebo (a dummy treatment) in one main study in 262 adult patients with CTEPH who could not have surgery, or in whom CTEPH remained or returned after surgery. Before treatment, the patients could walk an average of 347 metres in 6 minutes. After 16 weeks of treatment with Adempas, patients could walk an average of 46 metres further in 6 minutes than patients taking placebo.
• The medicine was also compared with placebo in another main study in 445 adult patients with PAH. Before treatment, the patients could walk an average of 363 metres in 6 minutes. After 12 weeks, patients treated with Adempas could walk an average of 36 metres further in 6 minutes than patients taking placebo.
• A main study also showed that Adempas can improve walking distance and other signs of heart function in children. Based on evidence from this study, the medicine is expected to work as well in children as it does in adults.
For the full list of side effects and restrictions with Adempas, see the package leaflet.
The most common side effects with Adempas (which may affect more than 1 in 10 people) include 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).
Adempas must not be used in patients with severely reduced liver function, with low systolic blood pressure (blood pressure when the heart is contracting) or with pulmonary hypertension associated with idiopathic interstitial pneumonia (scarring of the lungs with unknown cause). It must also not be used during pregnancy, or together with certain other medicines used to treat heart conditions.
The European Medicines Agency 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 it considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan. The Agency therefore decided that Adempas’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adempas have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Adempas are continuously monitored. Side effects reported with Adempas are carefully evaluated and any necessary action taken to protect patients.
Adempas received a marketing authorisation valid throughout the European Union on 27 March 2014.
Product information
Latest procedure affecting product information:
N/0042
30/07/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Adempas
- Active substance
- riociguat
- International non-proprietary name (INN) or common name
- riociguat
- Therapeutic area (MeSH)
- Hypertension, Pulmonary
- Anatomical therapeutic chemical (ATC) code
- C02KX05
Pharmacotherapeutic group
Antihypertensives for pulmonary arterial hypertensionTherapeutic 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.
Pulmonary arterial hypertension (PAH)
Adults
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.
Paediatrics
Adempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.
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