Adempas® (Riociguat): New contraindication for patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)

Bayer (South East Asia) Pte Ltd would like to inform healthcare professionals that Adempas® (riociguat) should not be used in patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP). Interim results from the RISE-IIP study, which evaluated efficacy and safety of riociguat in patients with symptomatic PH-IIP showed an increased risk of mortality and serious adverse events (such as respiratory disease or lung infections) among subjects receiving riociguat compared to those receiving placebo. The available data do not indicate a clinically significant benefit in these patients and the study was terminated early on the recommendation of the Data Monitoring Committee. Adempas® is not authorised for use in patients with PH-IIP. The benefit-risk profile of Adempas® for its approved indications for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) remains positive. Please refer to the letter for details.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.