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Moderate RV Dysfunction

Moderate RV Dysfunction Is an Indicator of Intermediate Risk1

An early indicator of PAH progression is worsening right heart function.2

With most patients at intermediate risk at diagnosis, their right heart function needs to be assessed every 3 to 6 months. This may identify progression early to help patients achieve low-risk status in a timely manner.1,3

RV Changes Occur Before Other Indicators of PAH Progression2

  • Detrimental RV structure changes may happen in as little as 12 weeks, and come before lagging indicators like FC and 6MWD2,4
  • RV dysfunction is the first warning sign on the path to potential hospitalization2
Image showing which PAH indicators change over time.

Recent Guideline Updates Place a Greater Emphasis on RV Function1

  • Both REVEAL Lite 2 and the updated 2022 ESC/ERS Guidelines emphasize using echocardiography when assessing RV function and its effect on PAH progression1,5
  • Right heart imaging results may suggest worsening prognosis, even if risk status is stable5

To read more about RV dysfunction and PAH progression, explore the Publications Library.

View Publications

Right Heart Assessment Milestones

Guidelines recommend echocardiography and RHC at least every 6 months and as early as 3 months after a change in therapy. See how timely risk assessments may help your patient achieve low-risk status—a key goal in PAH.1,6*

*Intervals may need to be adjusted according to patient needs.1

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; RHC=right heart catheterization; RV=right ventricle/right ventricular.

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. 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. 2. 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. 3. Hoeper MM, Kramer T, Pan Z, et al. Mortality in pulmonary arterial hypertension: prediction by the 2015 European pulmonary hypertension guidelines risk stratification model. Eur Respir J. 2017;50(2):1700740. 4. Simonneau G, Barst RJ, Galie N, et al; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165(6):800-804. 5. Sahay S, Bhatt J, Beshay S, et al. E-REVEAL Lite 2.0 scoring for early prediction of disease progression in pulmonary arterial hypertension. Pulm Circ. 2022;12(1):e12026. 6. 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.