Direct healthcare professional communication on a new contraindication for Adempas (riociguat) in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
04.07.2016
Bayer d.o.o. and Merck Sharp & Dohme d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals of a new contraindication for Adempas (riociguat) in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP).
Summary
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) should not be treated with riociguat.
- The RISE-IIP study, which evaluated efficacy and safety of riociguat in patients with symptomatic PH-IIP has been terminated early. Riociguat is not authorised for this indication. This study has not been conducted in the Republic of Croatia.
- Interim results of RISE-IIP showed an increased risk of mortality and serious adverse events among subjects receiving riociguat compared to those receiving placebo. The available data do not indicate a clinically significant benefit in these patients.
- If any patients with PH-IIP are being treated with riociguat their treatment should be discontinued and their clinical status carefully monitored.
- The benefit-risk profile of Adempas in its approved indications remains positive.
Further information
Adempas is approved for use in patients with WHO Functional Class (FC) II-III inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgery, and in patients with WHO FC II-III pulmonary arterial hypertension (PAH). Adempas works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs. By widening the pulmonary arteries, Adempas leads to an improvement in the ability to carry out physical activity.
Adempas is not authorised for the treatment of pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). RISE-IIP was recently terminated early on the recommendation of the Data Monitoring Committee (DMC). An evaluation of the interim results by the EMA concluded that the benefit risk balance of riociguat in patients with PH-IIP is negative. This study has not been conducted in the Republic of Croatia.
The information for healthcare professionals in the Adempas Summary of Product Characteristics (SmPC) and the information for patients in the package leaflet will be updated with new contraindication in patients with PH-IIP.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
