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Developed under the direction and sponsorship of United Therapeutics Corporation.

Orenitram enables you to introduce the prostacyclin pathway early¹

FOR PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) TO
IMPROVE EXERCISE CAPACITY

If your patient isn’t moving toward these parameters, it
may be time to consider a change in therapy²

PATIENT ACTIVITY	RIGHT HEART FUNCTION
NYHA FC I or II	Normal/Near-normal RV size and function
6MWD>380 to 440 m	Normal BNP
CPET: peak VO₂>15 mL/min/kg and EqCO₂<45 L/min/L/min	RAP<8 mm Hg; CI>2.5 to 3.0 L/min/m²

6MWD=6-minute walk distance; BNP=B-type natriuretic peptide; CI=cardiac index; CPET=cardiopulmonary exercise test; EqCO₂=ventilatory equivalent for carbon dioxide; FC=functional class; NYHA=New York Heart Association; RAP=right atrial pressure;

RV=right ventricular; VO₂=oxygen consumption.

Orenitram can help fill the treatment gap between initial therapy and parenteral treatment

•	Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C)
•	There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients
•	Safety and effectiveness in patients under 18 years of age have not been established

Please see the complete Important Safety Information below and the
Full Prescribing Information and Patient Information for Orenitram.

to receive your Orenitram Start Guide or
VISIT ORENITRAM.COM to see Orenitram study data.

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.

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

CONTRAINDICATIONS

•	Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C)

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).

References: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017. 2. McLaughlin VV, Gaine SP, Howard LS, et al. Treatment goals of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25 suppl):D73-81.