Date: 22 July 2016

Description:

Adempas® (riociguat) should not be used in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). Riociguat is not approved for this indication. This recommendation follows the early termination of a phase II clinical trial called RISE-IIP study, which evaluated the efficacy and safety of riociguat in patients with symptomatic PH-IIP. 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. The Malaysian Adempas® package insert will be updated to add a contraindication for PH-IIP to help ensure that riociguat is not used 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. Please refer to the Direct Healthcare Professional Communication (DHPC) for more details.