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Adempas® (Riociguat): New Contraindication for Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP)

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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.

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

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