ASSIST® for ORENITRAM® (treprostinil)

Product Distribution for Orenitram

United Therapeutics has contracted with a limited distribution network of authorized specialty distributors and wholesalers that have made a commitment to product integrity and patient safety.

ASSIST works with these specialty distributors (also known as Specialty Pharmacies or SPs) to help determine what type of product distribution is right for your patient’s prescribed medication.

Orenitram Specialty Pharmacy Network:

Phone 1-866-344-4874

Website accredo.com

Questions?

You can call ASSIST at 1-877-864-8437, Monday - Friday, 8:30 am to 7:00 pm ET or email ASSIST at assist@unither.com.

Indication

Orenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.

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.

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

CONTRAINDICATIONS

Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C)

WARNINGS AND PRECAUTIONS

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

DRUG INTERACTIONS / SPECIFIC POPULATIONS

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

ADVERSE REACTIONS

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