"The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs. It make"...
Pulmonary Arterial Hypertension
Orenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.
The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
DOSAGE AND ADMINISTRATION
Take Orenitram with food. Swallow Orenitram tablets whole; do not crush, split, or chew.
The recommended starting dose of Orenitram is 0.25 mg twice daily (BID) with food, taken approximately 12 hours apart or 0.125 mg three times daily (TID) with food, taken approximately 8 hours apart. Increase the dose to the highest tolerated dose. The recommended increment is 0.25 or 0.5 mg BID or 0.125 mg TID every 3-4 days. If dose increments are not tolerated consider titrating slower.
The appropriate maintenance dose is determined by tolerability.
If intolerable pharmacologic effects occur, decrease the dose in increments of 0.25 mg. Avoid abrupt discontinuation [see WARNINGS AND PRECAUTIONS].
Transitioning From Subcutaneous Or Intravenous Routes Of Administration Of Treprostinil
Decrease the dose of Remodulin while simultaneously increasing the dose of Orenitram. The dose of Remodulin can be reduced up to 30 ng/kg/min per day and the dose of Orenitram simultaneously increased up to 6 mg per day (2 mg TID) if tolerated. The following equation can be used to estimate a comparable total daily dose of Orenitram in mg using a patient's dose of IV/SC treprostinil (in ng/kg/min) and weight (in kg).
Orenitram total daily dose (mg) = 0.0072 x Remodulin dose (ng/kg/min) x weight (kg)
Dose Adjustment In Patients With Hepatic Impairment
In patients with mild hepatic impairment (Child Pugh Class A) start at 0.125 mg BID with 0.125 mg BID dose increments every 3 to 4 days. Avoid use of Orenitram in patients with moderate hepatic impairment (Child Pugh Class B). Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C) [see CONTRAINDICATIONS, Use in Specific Populations, and CLINICAL PHARMACOLOGY].
Dose Adjustment For Use With CYP2C8 Inhibitors
When co-administered with strong CYP2C8 inhibitors (e.g., gemfibrozil) the initial dose is 0.125 mg BID with 0.125 mg BID dose increments every 3 to 4 days.
Interruptions And Discontinuation
If a dose of medication is missed, the patient should take the missed dose as soon as possible, with food. If a patient misses two or more doses, restart at a lower dose and re-titrate.
In the event of a planned short-term treatment interruption for patients unable to take oral medications, consider a temporary infusion of subcutaneous or intravenous treprostinil. To calculate the total daily dose (mg) of treprostinil for the parenteral route use the following equation:
Remodulin (ng/kg/min) = 139 x Orenitram total daily dose (mg) / weight (kg)
When discontinuing Orenitram, reduce the dose in steps of 0.5 to 1 mg per day [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
Orenitram (treprostinil) extended-release tablets are available in the following four strengths:
- 0.125 mg [White tablet imprinted with UT 0.125]
- 0.25 mg [Green tablet imprinted with UT 0.25]
- 1 mg [Yellow tablet imprinted with UT 1]
- 2.5 mg [Pink tablet imprinted with UT 2.5]
Storage And Handling
Orenitram is an 8 mm round biconvex tablet with strength identifying color and printing and supplied as follows:
|Strength||Color||Printing on Tablets||NDC # 100-Count Bottle||NDC # 10-Count Bottle|
|0.125 mg||White||UT 0.125||66302-300-01||66302-300-10|
|0.25 mg||Green||UT 0.25||66302-302-01||66302-302-10|
|1 mg||Yellow||UT 1||66302-310-01||66302-310-10|
|2.5 mg||Pink||UT 2.5||66302-325-01||66302-325-10|
Store at 25°C (77°F); excursions 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Keep out of reach of children.
United Therapeutics Corp., Research Triangle Park, NC 27709 USA. Revised: Jan 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2016
Additional Orenitram Information
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