For When Your Patients Need More

Clinical Improvement for Patients Who Need It^1,2*

Some intermediate-risk patients may be at higher risk than they appear and not where they need to be.^3,4 See how regularly monitoring trends in RV dysfunction may help identify a stagnant or declining patient sooner.

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CONSIDER ORENITRAM

Risk Parameters^3,5	LOW RISK	INTERMEDIATE -LOW	INTERMEDIATE -HIGH	HIGH
FC	I or II	-	III	IV
6MWD	>440 m	320- 440 m	165- 319 m	<165 m
BNP or NT-proBNP	<50 ng/L <300 ng/L	50-199 ng/L 300-649 ng/L	200-800 ng/L 650-1100 ng/L	>800 ng/L >1100 ng/L

*2022 guidelines define measures of risk as 6MWD, FC, and NT-proBNP.⁵

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 are^1,6,7:

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.⁵
^†Approximately 40% of appropriate patients refuse parenteral therapy.⁸

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

Choose the Appropriate Dosing Approach for Your Patient’s Clinical Needs

Reaching a therapeutic dose is important to achieving clinical improvement, but individual patient needs may vary based on¹:

RISK
assessment

TIME needed to reach necessary exposure

DOSING PREFERENCE to achieve goals

Orenitram dosing approaches may help your patients reach necessary exposure.

Established clinical efficacy and safety¹

See the results of Orenitram on leading and lagging indicators of disease progression.

View the Data >

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; FC=functional class; NT-proBNP=N-terminal pro–B-type natriuretic peptide; PAH=pulmonary arterial hypertension; RV=right ventricular/right ventricle.

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, 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. 3. Hoeper MM, Pausch C, Olsson KM, et al. COMPERA 2.0: a refined four-stratum risk assessment model for pulmonary arterial hypertension. Eur Respir J. 2022;60(1):2102311. 4. Sahay S, Tonelli AR, Selej M, et al. Risk assessment in patients with functional class II pulmonary arterial hypertension: comparison of physician gestalt with ESC/ERS and the REVEAL 2.0 risk score. PLoS One. 2020;15(11):e0241504. 5. 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. 6. 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. 7. 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. 8. Data on file. United Therapeutics Corporation. Research Triangle Park, NC.