CardioSource WorldNews December 2014 - Page 17

ADEMPAS (riociguat) tablets, for oral use Initial U.S. Approval: 2013 BRIEF SUMMARY of PRESCRIBING INFORMATION For additional information, please see the full Prescribing Information at WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning • Do not administer Adempas to a pregnant female because it may cause fetal harm. (4.1, 5.1, 8.1) • Females of reproductive potential: Exclude pregnancy before start of treatment, monthly during treatment, and 1 month after treatment discontinuation. Prevent pregnancy during treatment and for one month after treatment discontinuation by use of acceptable methods of contraception. (2.3, 5.1, 5.2, 8.6) • For females, Adempas is available only through a restricted program called the Adempas REMS Program. (5.1, 5.2). 1 INDICATIONS AND USAGE 1.1 Chronic-Thromboembolic Pulmonary Hypertension Adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class [see Clinical Studies (14.1)]. 1.2 Pulmonary Arterial Hypertension Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening. Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%) [see Clinical Studies (14.2)]. 4 CONTRAINDICATIONS 4.1 Pregnancy Adempas may cause fetal harm when administered to a pregnant woman. Adempas is contraindicated in females who are pregnant. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)]. 4.2 Nitrates and Nitric Oxide Donors Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. 4.3 Phosphodiesterase Inhibitors Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. 5 WARNINGS AND PRECAUTIONS 5.1 Embryo-Fetal Toxicity Adempas may cause fetal harm wh [