Indications for ORENITRAM:
Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to delay disease progression and improve exercise capacity.
Take with food. Swallow whole. Individualize. Initially 0.25mg twice daily (~12hrs apart) or 0.125mg three times daily (~8hrs apart). Titrate by 0.125 three times daily or 0.25mg or 0.5mg twice daily every 3–4 days; if not tolerated, consider slower titration. If intolerable adverse effects occur, decrease in 0.125mg or 0.25mg increments. Mild hepatic impairment (Child Pugh Class A) or concomitant strong CYP2C8 inhibitors: initially 0.125mg twice daily; titrate by increments of 0.125mg twice daily every 3–4 days. Moderate hepatic impairment (Child Pugh Class B): avoid. 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). Diverticulosis or blind-end pouches. Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Potentiated by CYP2C8 inhibitors (eg, gemfibrozil); see Adults.
Headache, diarrhea, nausea, vomiting, flushing, pain in extremity, jaw pain, hypokalemia, abdominal discomfort.
Generic Drug Availability:
Ext-rel tabs—10, 100