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Why Orenitram

For When Your Patients Need More

Bridge the Gap

Bridge the Gap With Orenitram

Orenitram provides clinical intervention for when intermediate-risk patients need improvement in key measures of risk,* and may help patients who are1-3:

Stagnant or Declining on Initial or Current Therapy

Inappropriate for or Refusing Parenteral Therapy†

*2022 Guidelines define measures of risk as 6MWD, FC, and NT-proBNP.4

†Approximately 40% of appropriate patients refuse parenteral therapy.6

Table showing risk parameters, highlighting intermediate risk for choosing Orenitram (Mobile)

To learn more about how Orenitram may help your intermediate risk patients, watch the video.

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Explore dosing approaches to ensure patients reach necessary exposure.

Learn More

Mechanism of Action

See how Orenitram mimics naturally produced prostacyclin to address the pathological changes in PAH.

Established Clinical Efficacy

Learn how Orenitram may provide clinical improvement for patients who need it.

A Confident Start

Read about the steps you and your patient may take to help them feel confident as they begin taking Orenitram.

6MWD=6-minute walk distance; BNP=B-type natriuretic peptide; CI=cardiac index; FC=functional class; mPAP=mean pulmonary arterial pressure; NT-proBNP=N-terminal pro–B-type natriuretic peptide; PAH=pulmonary arterial hypertension; PAWP=pulmonary arterial wedge pressure; PVR=pulmonary vascular resistance; RAP=right atrial pressure; RHC=right heart catheterization; SvO2=mixed venous oxygen saturation; WHO=World Health Organization; WU=Wood units.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

Contraindications

  • Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

Adverse Reactions

  • In the 12-week, placebo-controlled, monotherapy study, and an event-driven placebo-controlled, combination therapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, vomiting, flushing, pain in jaw, pain in extremity, hypokalemia, abdominal discomfort, and upper abdominal pain.

Warnings and Precautions

  • Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
  • The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.

Drug Interactions

  • Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.

Specific Populations

  • Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies with Orenitram in pregnant women.
  • It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.
  • Safety and effectiveness of Orenitram in pediatric patients have not been established.
  • Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients.

INDICATION

Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).

OREISIhcpOCT19

Please see Full Prescribing Information and Patient Information at www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).

References: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2023. 2. White RJ, Jerjes-Sanchez C, Bohns Meyer GM, et al; FREEDOM-EV Investigators. Combination therapy with oral treprostinil for pulmonary arterial hypertension. A double-blind placebo controlled clinical trial. Am J Respir Crit Care Med. 2020;201(6):707-717. 3. Benza RL, Gomberg-Maitland M, Farber HW, et al. Contemporary risk scores predict clinical worsening in pulmonary arterial hypertension – an analysis of FREEDOM-EV. J Heart Lung Transplant. 2022;41(suppl):1-12. 4. Humbert M, Kovacs G, Hoeper MM, et al; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022;43(38):3618-3731. 5. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 6. Ramani G, Cassady S, Shen E, et al. Novel dose-response analyses of treprostinil in pulmonary arterial hypertension and its effects on six-minute walk distance and hospitalizations. Pulm Circ. 2020;10(3):2045894020923956. Published 2020 Oct 27. 7. White RJ, Grünig E, Jerjes-Sanchez C, et al. Dose-response relationship of oral treprostinil for secondary endpoints in the FREEDOM-EV study. Poster presented at: European Respiratory Society International Congress; September 28-October 2, 2019; Madrid, Spain. 8. Sargent T, Hansen L, Hohsfield R. Transitions between infused and oral prostacyclin pathway agents in pulmonary arterial hypertension: key considerations. Pulm Circ. 2020;10(3):2045894020931324. Published 2020 Jun 15.