Generic Name and Formulations:
Treprostinil 0.125mg, 0.25mg, 1mg, 2.5mg, 5mg; ext-rel osmotic tabs.
United Therapeutics Corp.
Indications for ORENITRAM:
Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to improve exercise capacity.
Take with food. Swallow whole. Individualize. Initially 0.25mg twice daily (~12hrs apart) or 0.125mg three times daily (~8hrs apart). May increase in increments of 0.25mg or 0.5mg twice daily every 3–4 days; if not tolerated, consider titrating slower. 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.
Severe hepatic impairment (Child Pugh Class C).
Avoid abrupt withdrawal or sudden large dose reduction (see full labeling). Increased risk of bleeding. Diverticulosis or blind-end pouches. Hepatic impairment. Elderly. Labor & delivery. Pregnancy (Cat. C). Nursing mothers: not recommended.
Increased risk of symptomatic hypotension with concomitant diuretics, antihypertensives, or other vasodilators. Increased risk of bleeding with anticoagulants. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil); see Adult.
Headache, nausea, diarrhea, flushing, pain in extremity, jaw pain, hypokalemia, abdominal discomfort.
Ext-rel tabs—10, 100