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Developed under the direction and sponsorship of United Therapeutics Corporation. Important Safety Information |  Prescribing Information |  Patient Support |  Orenitram Website Helping your patients start and stay on Orenitram FOR PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) TO IMPROVE EXERCISE CAPACITY Proactive side effect management can help reassure patients Patients with pulmonary arterial hypertension (PAH) starting Orenitram may experience some of the most common adverse reactions (incidence >5%) that were reported in clinical studies such as headache, diarrhea, nausea, and flushing. Consider the following patient management techniques when initiating Orenitram: Setting realistic expectations regarding benefits and risks of Orenitram may help patients understand treatment challenges from the start. Educating patients on common side effects of prostacyclin-class therapies may help your patients who develop side effects to be prepared. Proactively managing common side effects associated with Orenitram. PAH=pulmonary arterial hypertension; WHO=World Health Organization. CONTRAINDICATIONS • Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C) Please see additional Important Safety Information below and the Full Prescribing Information and Patient Information for Orenitram. Download a Copy of the Patient Management Approaches brochure INDICATION Orenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this. ADDITIONAL IMPORTANT SAFETY INFORMATION FOR ORENITRAM WARNINGS AND PRECAUTIONS • Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms • Orenitram inhibits platelet aggregation and increases the risk of bleeding • The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum DRUG INTERACTIONS / SPECIFIC POPULATIONS • Concomitant administration of Orenitram with diuretics, antihypertensive agents, or other vasodilators increases the risk of symptomatic hypotension • Orenitram inhibits platelet aggregation; there is an increased risk of bleeding, particularly among patients receiving anticoagulants • Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients • Pregnancy Category C. Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans • It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, choose Orenitram or breastfeeding • Safety and effectiveness in patients under 18 years of age have not been established • There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients ADVERSE REACTIONS • In the 12-week placebo-controlled monotherapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, flushing, pain in jaw, pain in extremity, hypokalemia, and abdominal discomfort OREISIhcpJAN16 Please see the Full Prescribing Information and Patient Information for Orenitram. For additional information about Orenitram, visit www.orenitram.com or call 1-877-UNITHER (1-877-864-8437). Orenitram is a registered trademark of United Therapeutics Corporation. © 2017 United Therapeutics Corporation. All rights reserved. US/ORE/0200 Help Password Assistance Privacy Policy Unsubscribe from WebMD Professional Clinical Update Unsubscribe from WebMD Professional Clinical emails WebMD Professional Services 825 Eighth Avenue New York, NY 10019 This promotional communication is provided by WebMD Professional Services.