ASSIST for REMODULIN (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

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

Important Safety Information for Remodulin

Warnings and Precautions
  • Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
  • Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
  • Remodulin is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding.
Adverse Reactions
  • In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache (27% vs. 23%), diarrhea (25% vs. 16%), nausea (22% vs. 18%), rash (14% vs. 11%) jaw pain (13% vs. 5%), vasodilatation (11% vs. 5%), edema (9% vs. 3%), and hypotension (4% vs. 2%).
Drug Interactions
  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
Specific Populations
  • In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.
  • Safety and effectiveness of Remodulin in pediatric patients have not been established.
  • It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.

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.