For US Physicians Only
PAH Overview
About PAH Importance of prostacyclin therapy
About Orenitram
Overview Pharmacologic actions
Efficacy and Safety
Improvement in 6MWD Adverse events Open-label extension study AE management strategies
Dosage
Dosage and administration BID/TID pharmacokinetics
Access and Support
Support for your practice Starting a patient Resources Referral Portal Request a Rep
Full Circle Video Learning Series

Orenitram Referral Portal

Log in or register to access the Orenitram Referral Portal

ASSIST is a centralized referral and reimbursement service that facilitates the referral process for healthcare providers and patients. The Orenitram Referral Portal allows you to track the status of prescriptions for your patients who have been prescribed Orenitram. Log in or register today.

REGISTER for the Orenitram Referral Portal

E-mail address: Invalid e-mail format

Password: This field cannot be left blank

Forgot password?

For questions about the Orenitram Referral Portal, contact ASSIST at 1-877-864-8437.

Hours of operation: M-F 8:30 AM–7:00 PM ET

Important Safety Information for Orenitram

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

DRUG INTERACTIONS/SPECIFIC POPULATIONS

ADVERSE REACTIONS

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.

OREISIhcpJAN16

Please see the Full Prescribing Information and Patient Information for Orenitram.

For additional information about Orenitram, call 1-877-UNITHER (1-877-864-8437).

References: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014. 2. Jing ZC, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013;127(5):624-633.

References: 1. Archer SL, Marsboom G, Kim GH, et al. Epigenetic attenuation of mitochondrial superoxide dismutase 2 in pulmonary arterial hypertension: a basis for excessive cell proliferation and a new therapeutic target. Circulation. 2010;121(24):2661-2671. 2. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association. J Am Coll Cardiol. 2009;53(17):1573-1619. 3. Michelakis ED, Wilkins MR, Rabinovitch M. Emerging concepts and translational priorities in pulmonary arterial hypertension. Circulation. 2008;118(14):1486-1495. 4. Schiebler ML, Bhalla S, Runo J, et al. Magnetic resonance and computed tomography imaging of the structural and functional changes of pulmonary arterial hypertension. J Thorac Imaging. 2013;28(3):178-195. 5. Bogaard HJ, Abe K, Noordegraaf AV, Voelkel NF. The right ventricle under pressure: cellular and molecular mechanisms of right-heart failure in pulmonary hypertension. Chest. 2009;135(3):794-804. 6. Champion HC, Michelakis ED, Hassoun PM. Comprehensive invasive and noninvasive approach to the right ventricle–pulmonary circulation unit. State of the art and clinical and research implications. Circulation. 2009;120(11):992-1007. 7. Barst R. How has epoprostenol changed the outcome for patients with pulmonary arterial hypertension? lnt J Clin Pract. 2010;64(suppl 168):23-32. 8. Badano LP, Ginghina C, Easaw J, et al. Right ventricle in pulmonary arterial hypertension: haemodynamics, structural changes, imaging, and proposal of a study protocol aimed to assess remodelling and treatment effects. Eur J Echocardiogr. 2010;11(1):27-37. 9. Voelkel NF, Quaife R, Leinwand LA, et al. Right ventricular function and failure: report of a National Heart, Lung, and Blood Institute working group on cellular and molecular mechanisms of right heart failure. Circulation. 2006;114(17):1883-1891. 10. Tonelli AR, Arelli V, Minai OA, et al. Causes and circumstances of death in pulmonary arterial hypertension. Am J Respir Crit Care Med. 2013;188(3):365-369. 11. Galiè N, Torbicki A, Barst R, et al. Guidelines on diagnosis and treatment of pulmonary arterial hypertension: the Task Force on Diagnosis and Treatment of Pulmonary Arterial Hypertension of the European Society of Cardiology. Eur Heart J. 2004;25(24):2243-2278. 12. Hoeper MM, Bogaard HJ, Condliffe R, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25):D42-50. 13. Elliot CA, Kiely DG. Pulmonary hypertension. Contin Educ Anaesth Crit Care Pain. 2006;6(1):17-22. 14. Palevsky HI. The early diagnosis of pulmonary arterial hypertension: can we do better? Chest. 2011;140(1):4-6. 15. Brown LM, Chen H, Halpern S, et al. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL Registry. Chest. 2011;140(1):19-26. 16. Badesch DB, Raskob GE, Elliott CG. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010;137(2):376-387.

References: 1. Jing ZC, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013;127(5):624-633. 2. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association. J Am Coll Cardiol. 2009;53(17):1573-1619. 3. Gomberg-Maitland M, Olschewski H. Prostacyclin therapies for the treatment of pulmonary arterial hypertension. Eur Respir J. 2008;31(4):891-901. 4. Tuder RM, Cool CD, Geraci MW, et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am J Respir Crit Care Med. 1999;159(6):1925-1932. 5. McLaughlin VV, McGoon MD. Pulmonary arterial hypertension. Circulation. 2006;114(13):1417-1431. 6. Badesch DB, Raskob GE, Elliott CG, et al. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010;137(2):376-387.

References: 1. Jing ZC, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013;127(5):624-633. 2. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

References: 1. Rahaghi FF, Feldman JP, Allen RP, et al. The Delphi process in the creation of a consensus statement for practical use of Orenitram. Presented at: American Thoracic Society International Conference, May 15-20, 2015; Denver, CO. 2. Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. Practical Assess, Res Eval. 2007;12(10). http://pareonline.net/getvn.asp?v=12&n=10. Accessed June 9, 2015. 3. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000;32(4):1008-1015. 4. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014. 5. Lim A, Wang-Smith L, Kates J, Laurent A, Kumar P, Laliberte K. The effect of different meal compositions on the oral bioavailability of treprostinil diolamine in healthy volunteers. J Clin Pharm Ther. 2013;38(6):450-455.

Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

References: 1. Rahaghi FF, Feldman JP, Allen RP, et al. The Delphi process in the creation of a consensus statement for practical use of Orenitram. Presented at: American Thoracic Society International Conference, May 15-20, 2015; Denver, CO. 2. Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. Practical Assess, Res Eval. 2007;12(10). http://pareonline.net/getvn.asp?v=12&n=10. Accessed June 9, 2015. 3. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000;32(4):1008-1015. 4. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014. 5. Lim A, Wang-Smith L, Kates J, Laurent A, Kumar P, Laliberte K. The effect of different meal compositions on the oral bioavailability of treprostinil diolamine in healthy volunteers. J Clin Pharm Ther. 2013;38(6):450-455.

Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

EXPAND

Important Safety Information for Orenitram

Important Safety Information for Orenitram

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

DRUG INTERACTIONS/SPECIFIC POPULATIONS

ADVERSE REACTIONS

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.

OREISIhcpJAN16

Please see the Full Prescribing Information and Patient Information for Orenitram.

For additional information about Orenitram, call 1-877-UNITHER (1-877-864-8437).