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| PAH=pulmonary arterial hypertension; WHO=World Health Organization. |
| An Industry Theater Presentation at the ATS 2017 International Conference. This presentation is sponsored by United Therapeutics. Due to regulatory restrictions, this presentation is only available to attendees from the United States.
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| Indication |
| Orenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.
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| The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
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Important Safety Information
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Contraindications
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- Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C)
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Warnings and Precautions
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- Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms
- Orenitram inhibits platelet aggregation and increases the risk of bleeding
- The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum
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Drug Interactions / Specific Populations
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- Concomitant administration of Orenitram with diuretics, antihypertensive agents, or other vasodilators increases the risk of symptomatic hypotension
- Orenitram inhibits platelet aggregation; there is an increased risk of bleeding, particularly among patients receiving anticoagulants
- Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients
- Pregnancy Category C. Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans
- It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, choose Orenitram or breastfeeding
- Safety and effectiveness in patients under 18 years of age have not been established
- There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients
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Adverse Reactions
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- In the 12-week placebo-controlled monotherapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, flushing, pain in jaw, pain in extremity, hypokalemia, and abdominal discomfort
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