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Orenitram Generic Name & Formulations
Legal Class
Rx
General Description
Treprostinil 0.125mg, 0.25mg, 1mg, 2.5mg, 5mg; ext-rel osmotic tabs.
Pharmacological Class
Prostacyclin analogue.
How Supplied
Ext-rel tabs—10, 100
Manufacturer
Generic Availability
NO
Orenitram Indications
Indications
Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to delay disease progression and improve exercise capacity.
Orenitram Dosage and Administration
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.
Orenitram Contraindications
Contraindications
Severe hepatic impairment (Child Pugh Class C).
Orenitram Boxed Warnings
Not Applicable
Orenitram Warnings/Precautions
Warnings/Precautions
Avoid abrupt withdrawal or sudden large dose reduction (see full labeling). Diverticulosis or blind-end pouches. Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Orenitram Pharmacokinetics
See Literature
Orenitram Interactions
Interactions
Potentiated by CYP2C8 inhibitors (eg, gemfibrozil); see Adults.
Orenitram Adverse Reactions
Adverse Reactions
Headache, diarrhea, nausea, vomiting, flushing, pain in extremity, jaw pain, hypokalemia, abdominal discomfort.
Orenitram Clinical Trials
See Literature
Orenitram Note
Not Applicable
Orenitram Patient Counseling
See Literature
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