Adempas
Authorised
riociguat
Medicine
Human
Authorised
Adempas is a medicine used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs). It is used in the following types of pulmonary hypertension:
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.
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. For children weighing below 50 kg Adempas is also available as granules that can be made up into a liquid to be taken by mouth.
The usual recommended starting dose depends on the patient’s bodyweight and is taken 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:
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 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.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
Chronic thromboembolic pulmonary hypertension (CTEPH)
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
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.