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Useful Resources—For When You Need More

Orenitram Videos

Why Orenitram?

Discover how Orenitram provides clinical intervention for when patients need improvement in key measures of risk.1-3*

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

Orenitram Titration Kit

See how the Orenitram Titration Kit may guide your patient through the first 3 months of their treatment journey.

Hear From PAH Experts

Discussion of FREEDOM-EV Trial

Hear the principal investigator of FREEDOM-EV, R. James White, MD, PhD, discuss the trial’s background and important outcomes.

Right Heart Function in FREEDOM-EV

Learn about the impact of Orenitram on right heart function in the FREEDOM-EV trial from Paul Forfia, MD.

Measuring Risk and the Impact of Orenitram

See the effect that Orenitram had on several key risk parameters—as well as overall risk status—in FREEDOM-EV with Jean Elwing, MD.

Dosing and AE Management as a Team

Listen to Franck Rahaghi, MD, and Starlet Harrimon, RN, as they discuss how risk assessment measures and planning for expected adverse effects can help guide treatment with Orenitram.

Additional Support Resources

iAssist

Take advantage of iAssist, a centralized hub for Orenitram that helps initiate, facilitate, and simplify the referral process.

Cost and Financial Support

See how United Therapeutics may help with cost assistance and support for patients taking Orenitram.

Archways Program

Discover how a United Therapeutics Virtual Patient Educator may help your patients get started on Orenitram.

‡Articles may be restricted behind a paywall for nonsubscribers.

6MWD=6-minute walk distance; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=functional class; NT-proBNP=N-terminal pro–B-type natriuretic peptide; PAH=pulmonary arterial hypertension; WHO=World Health Organization.

IMPORTANT SAFETY INFORMATION

Contraindications

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

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.

IMPORTANT SAFETY INFORMATION

Contraindications

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

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.

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.

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 for Orenitram.

For additional information, 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.