Pulmonary hypertension:

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.

Adult:

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.

Children:

Not established.

Contraindications:

Severe hepatic impairment (Child Pugh Class C).

Warnings/Precautions:

Avoid abrupt withdrawal or sudden large dose reduction (see full labeling). Diverticulosis or blind-end pouches. Hepatic impairment. Elderly. Pregnancy. Nursing mothers.

Pharmacologic Class:

Prostacyclin analogue.

Interactions:

Potentiated by CYP2C8 inhibitors (eg, gemfibrozil); see Adults.

Adverse Reactions:

Headache, diarrhea, nausea, vomiting, flushing, pain in extremity, jaw pain, hypokalemia, abdominal discomfort.

Generic Availability:

NO

How Supplied:

Ext-rel tabs—10, 100