"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. Orenitram is probably most useful to replace subcutaneous, intravenous, or inhaled treprostinil, but this use has not been studied.
DOSAGE AND ADMINISTRATION
Individualize dosing of Orenitram according to clinical response.
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 as tolerated to achieve optimal clinical response. 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 maximum dose is determined by tolerability. The mean dose in a controlled clinical trial at 12 weeks was 3.4 mg BID. Maximum doses studied were 12 mg BID in the 12-week blinded study and up to 21 mg BID in an open-label long-term study.
If intolerable pharmacologic effects occur, decrease the dose in increments of 0.25 mg. Avoid abrupt discontinuation [see WARNINGS AND PRECAUTIONS].
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, WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Concomitant Administration 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 divide the oral total daily dose by 5.
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) is available in the following four strengths:
- 0.125 mg [W hite 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
Last reviewed on RxList: 10/20/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Orenitram Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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