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Professional experiences with Orenitram
Overview of FREEDOM-EV
As the principal investigator of the FREEDOM-EV trial, R. James White, MD, PhD, talks about the background of the trial, key patient characteristics, and important outcomes.
Right Heart Function in FREEDOM-EV
The relationship between right heart dysfunction and clinical worsening in PAH is an important one, according to Paul Forfia, MD. Hear him discuss the impact of Orenitram on right heart function in the FREEDOM-EV trial.
Measuring Risk and the Impact of Orenitram
Consistent, formal risk assessment is key to managing treatment of PAH. Jean Elwing, MD, comments on the effect that Orenitram had on several key parameters of risk, as well as overall risk status in the FREEDOM-EV trial.
Dosing and AE Management as a Team
Striking a balance between proper dosing of Orenitram and managing side effects is key to getting the most out of therapy. Franck Rahaghi, MD, and Starlet Harrimon, RN, talk about how they work with patients, lessons learned from FREEDOM-EV, and how they use risk assessment measures as a guide to treating with Orenitram.
United Therapeutics does not provide medical advice.
Important Safety Information
- 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.
- 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.
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%).
AE=adverse event; PAH=pulmonary arterial hypertension.