Generic Name and Formulations:
Treprostinil 0.125mg, 0.25mg, 1mg, 2.5mg; ext-rel osmotic tabs.
Company:
United Therapeutics Corp.

Select therapeutic use: Pulmonary hypertension
Indications for ORENITRAM:
Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to improve exercise capacity.

Adult:
Take with food. Swallow whole. Individualize. Initially 0.25mg twice daily (~12hrs apart); may increase in increments of 0.25mg or 0.5mg twice daily every 3–4 days; if not tolerated, consider titrating slower. The total daily dose can be divided and given approx. 8 hrs apart, titrating by increments of 0.125mg three times daily. If intolerable adverse effects occur, decrease in 0.25mg increments. Mild hepatic impairment (Child Pugh Class A) or concomitant strong CYP2C8 inhibitors (eg, gemfibrozil): initially 0.125mg twice daily; titrate by increments of 0.125mg twice daily every 3–4 days. Moderate hepatic impairment (Child Pugh Class B): not recommended. Treatment interruption/discontinuation or transitioning from SC/IV treprostinil: see full labeling.

Children:
Not established.

Contraindications:
Severe hepatic impairment (Child Pugh Class C).

Warnings/Precautions:
Avoid abrupt withdrawal or sudden large dose reduction (see full labeling). Increased risk of bleeding. Hepatic impairment. Diverticulosis or blind-end pouches. Elderly. Labor & delivery. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:
Avoid alcohol. Increased risk of symptomatic hypotension with concomitant diuretics, antihypertensives, or other vasodilators. Increased risk of bleeding with anticoagulants. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil).

Pharmacological Class:
Prostacyclin analogue.

Adverse Reactions:
Headache, nausea, diarrhea, flushing, pain in extremity, jaw pain, hypokalemia, abdominal discomfort.

How Supplied:
Ext-rel tabs—10, 100