ASSIST for ORENITRAM (treprostinil)

Reveal Risk Calculator

The REVEAL Registry Risk Score Calculator developed by Dr. Raymond L. Benza helps predict survival in patients with PAH. Based on the patient’s predicted one-year survival, a risk group is assigned.1

Patients with PAH may perpetually be at risk for disease progression.2 As PAH is a progressive disease, assess risk status every 3-6 months.3

REVEAL is a multicenter, prospective registry of patients with incident or prevalent PAH (N=2525; enrolled March 2006-September 2007). The REVEAL risk score calculator was developed by assigning weighted values to assessment criteria that were independent predictors of survival in a multivariable Cox proportional hazard model. Based on 1-year survival, a patient’s risk was categorized as low (1-7), average (8), moderately high (9), high (10-11), or very high (≥12).

This calculator was validated in a cohort of 504 newly diagnosed patients. The REVEAL calculator demonstrated the average predicted survival rate for patients with risk. Note, there are many determinates of risk.

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%).

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

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.

OThe 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.

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For additional information please see Full Prescribing Information or call Customer Service at 1-877-UNITHER (1-877-864-8437)

References:

  1. Benza RL, Gomberg-Maitland M, Miller DP, et al. The REVEAL registry risk score calculator in patients newly diagnosed with pulmonary arterial hypertension. Chest. 2012;141(2):354-362.
  2. Klinger JR. Pulmonary arterial hypertension: monitoring the patient’s response to therapy, part 1. J Respir Dis. 2009;30:1-11.
  3. Galiè N, Humbert M, Vachiery JL, et al; for ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2016;37(1):67-119.