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PAH Disease Progression Makes It
Essential to Evaluate Risk Regularly1-3

Most Patients Are at Intermediate Risk at Diagnosis4

In an analysis of the prospective COMPERA registry, risk assessment was evaluated at baseline and follow-up for newly diagnosed patients with PAH.4

Risk Status at Diagnosis (N=1588)4*

Risk status pie chart showing 70% of PAH patients are at intermediate risk at baseline.

*Numbers do not add up to 100% due to rounding.

Rapid Progression and Regular Assessment

An early indicator of PAH disease progression is worsening right heart function.5

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 and may help patients achieve low-risk status in a timely manner.2,3

Patients within the vast intermediate-risk category may benefit from 4-strata assessments at follow-up, which allow for more granular decision-making.3

Many Patients Are Still at Intermediate Risk at Follow-Up2

More than 70% of patients are still at intermediate risk at follow-up. Timely identification of these patients may have a significant impact on disease progression.2,3

4-Strata Model Enables Earlier Identification of Patients Who Are Not at Goal or Are Declining3

Refined Cutoff Levels for 3- to 6-Month Follow-Up3

PAH 4 Strata Risk Model

“The intermediate-risk group of PAH can be tricky because many of our intermediate-risk patients will, on the surface, look relatively stable.”

—A PAH expert

Download the PAH Risk Assessment Sheet to see how you may determine your patients’ risk status.

Download Sheet

Start With the Heart

Discover how using right heart imaging and RHC every 3 to 6 months may help better define the needs of your intermediate-risk patients sooner than other indicators.3,5

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.

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. 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. 2. 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. 3. 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. 4. 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. 5. 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.