Why Orenitram?
Pulmonary arterial hypertension doesn't wait—and neither should treatment.
The first year after diagnosis is critical. 70% of patients are diagnosed with moderate PAH, and at intermediate risk, and the majority remain in intermediate-low or intermediate-high risk at first-follow-up.
Making timely treatment decisions for your intermediate-risk patients is key to getting them to low-risk, the goal in PAH.
Delays in care make it harder to manage disease progression.
Yet, PAH is unpredictable. And risk can shift.
Prioritize regular risk assessment to get ahead of unpredictable disease progression, recommended every 3 to 4 months.
A patient's risk level doesn't always tell the full story. That's why regular right heart, risk, and dose assessments can help you get ahead of unpredictable deterioration.
To make the right decisions, you need to know what's happening beneath the surface. Changes in the RV occur before other indicators of disease progression. While symptoms may appear stable, many patients experience underlying changes in right heart function.
Patients with PAH may have a deficiency of natural prostacyclin. Timely initiation of prostacyclin therapy in appropriate patients is important in managing PAH.
Orenitram is an oral prostacyclin mimetic with a multi-modal mechanism of action—Orenitram is for intermediate-risk patients who need more. For patients who are stagnant or declining on initial or current therapy, or are inappropriate for or refuse parenteral therapy, Orenitram provides clinical intervention for patients who need it.
We've learned a lot about Orenitram over the last decade, from patient identification in moderate PAH, dosing approaches, AE management, and titration. Clinical use and real-world data have shaped how it's prescribed today, primarily dosed three-times-a day to achieve an initial target of 9 milligrams or more. And with a consistent dose-response relationship, patients see improved clinical outcomes with increased exposure.
In FREEDOM-EV, Orenitram reduced the risk of disease progression, leading to a 25% reduction in risk of clinical worsening. Orenitram improves measures of risk including NT-proBNP, six-minute walk distance, and functional class. And, in a substudy, Orenitram improved key hemodynamics including pulmonary vascular resistance and cardiac output.
Orenitram can be initiated in prostacyclin-naive or prostacyclin-experienced patients.
For de novo patients, the Titration Kit simplifies dosing for a confident start.
For hemodynamically-stable patients on Remodulin, transitioning to Orenitram may be an appropriate option.
In the Transition Study, most patients successfully transitioned and maintained clinical stability at 24 weeks, with similar exposure.
Side effects with Orenitram are expected, particularly during titration. But with a proactive side effect management strategy, they may improve over time.
Support is available from day one. United Therapeutics Cares. We have resources available to help both providers and patients navigate treatment.
And our team will work one-on-one with your patients to provide ongoing, personalized support.
Backed by data and real-world experience, Orenitram provides clinical intervention for intermediate risk patients who need more.
So, assess risk. Consider time. And Bridge the Gap with Orenitram.
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 ORENITRAMContraindications
- Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.
- 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.
- 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.
- Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.
- 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.