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Orenitram Patient Profiles

For Improving Key Measures of Risk in Patients With Moderate PAH1-3*

Timely identification of intermediate-risk patients who are not at goal or are declining may have a significant impact on disease progression.4,5

The following hypothetical patient profiles present standard risk assessment variables at diagnosis and 3-month follow-up.

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

Patient Profiles†

  • 46-year-old woman diagnosed with idiopathic moderate PAH 3 months ago
  • Prescribed oral background therapy at time of diagnosis
  • Underwent follow-up risk assessment after 3 months of therapy
Lagging Indicators
MeasuresDiagnosisFirst Follow-Up
FCIIII
6MWD399 m420 m
Risk statusIntermediate (3-strata)Intermediate-low (4-strata)
Leading Indicators
Clinical ParametersDiagnosisFirst Follow-Up
NT-proBNP480 ng/L320 ng/L
Global RV functionMild dysfunctionMild dysfunction
TAPSE17 mm17 mm
TAPSE/sPAP0.26 mm/mm Hg0.26 mm/mm Hg
RA area23 cm223 cm2
Other measuresRV/RA dilation; IVS flatteningRV/RA dilation; IVS flattening

†Based on a hypothetical patient.

Although signs of improvement can be seen in 6MWD and NT-proBNP, most echo parameters remain stagnant, indicating this patient still has mild RV dysfunction and may benefit from the addition of Orenitram.

Echo May Help Detect PAH Progression Early4

Updated guidelines emphasize monitoring changes in RV function to track disease progression. Echos are a valuable tool for detecting moderate RV dysfunction early in patients with PAH who may otherwise appear stable—even if their FC and 6MWD are improving.4,7

Why Orenitram

Discover how Orenitram may provide clinical intervention for patients who need improvement in key measures of risk.

Orenitram Titration Kit weekly boxes

Dosing and Titration

See how Orenitram may meet your patient’s unique clinical needs.

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; FC=functional class; IVS=interventricular septum; NT-proBNP=N-terminal pro–B-type natriuretic peptide; PAH=pulmonary arterial hypertension; RA=right atrial; RV=right ventricular/right ventricle; sPAP=systolic pulmonary arterial pressure; TAPSE=tricuspid annular plane systolic excursion.

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. 5. 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. 6. Milks MW, Sahay S, Benza RL, et al. Risk assessment in patients with pulmonary arterial hypertension in the era of COVID 19 pandemic and the telehealth revolution: state of the art review. J Heart Lung Transplant. 2021;40(3):172-182. 7. 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.