Orenitram is indicated for the treatment of pulmonary arterial hypertension ( PAH ) ( WHO Group 1 ) to improve exercise capacity
FOR pulmonary arterial hypertension ORENITRAM DOSING ADAPTS request aN ORENITRAM representative or VISIT orenitram . com
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Introduce prostacyclin treatment early with Orenitram , which enables you to adjust dose based on tolerability and clinical response .
The only prostacyclin analogue in a tablet :
For PAH , a progressive disease 1-3
Orenitram allows you to initiate treatment with 0.125 mg TID (~ 8 hrs apart ) or 0.25 mg BID (~ 12 hrs apart ), then titrate up or down every 3 to 4 days as needed . In the pivotal trial , dose was titrated based on clinical response and tolerability . If not tolerated , titrate slower or decrease dose by 0.25 mg . Avoid abrupt discontinuation . Orenitram tablets should be taken whole and with food . If a dose is missed , please refer to the Full Prescribing Information . Orenitram should not be used in patients with moderate hepatic impairment . Dose adjustments required for mild hepatic impairment .
* In a 24-week , multicenter , open-label study to establish safety and tolerability of transition , WHO Group 1 patients ( FC I or II ) on stable doses of IV / SC treprostinil as well as a PDE-5i and / or ERA were evaluated .
INDICATION Orenitram is a prostacyclin vasodilator indicated for 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 .
Important Safety Information for Orenitram CONTRAINDICATIONS
• Orenitram is contraindicated in patients with severe hepatic impairment ( Child Pugh Class C )
WARNINGS AND PRECAUTIONS
• Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms
• Orenitram inhibits platelet aggregation and increases the risk of bleeding
• The Orenitram tablet shell does not dissolve . In patients with diverticulosis , Orenitram tablets can lodge in a diverticulum
DRUG INTERACTIONS / SPECIFIC POPULATIONS
• Concomitant administration of Orenitram with diuretics , antihypertensive agents , or other vasodilators increases the risk of symptomatic hypotension
• Orenitram inhibits platelet aggregation ; there is an increased risk of bleeding , particularly among patients receiving anticoagulants
• Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil ; therefore , Orenitram dosage reduction may be necessary in these patients
• Pregnancy Category C . Animal reproductive studies with Orenitram have shown an adverse effect on the fetus . There are no adequate and well-controlled studies in humans
• It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion . Because many drugs are excreted in human milk , choose Orenitram or breastfeeding
• Safety and effectiveness in patients under 18 years of age have not been established
• There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients
ADVERSE REACTIONS
• In the 12-week placebo-controlled monotherapy study , adverse reactions that occurred at rates at least 5 % higher on Orenitram than on placebo included headache , diarrhea , nausea , flushing , pain in jaw , pain in extremity , hypokalemia , and abdominal discomfort
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Early use in FC II and III 1
Please see the Brief Summary of the Full Prescribing Information for Orenitram on the following page .
For additional information about Orenitram , visit www . orenitram . com or call1-877-UNITHER ( 1-877-864-8437 ).
References 1 . Orenitram [ package insert ]. Research Triangle Park , NC : United Therapeutics Corporation ; 2015 . 2 . Clapp LH , Gurung R . The mechanistic basis of prostacyclin and its stable analogues in pulmonary arterial hypertension : role of membrane versus nuclear receptors . Prostaglandins Other Lipid Mediat . 201 ; 120:56-71 . 3 . McLaughlin VV et al . ACCF / AHA 2009 expert consensus on pulmonary hypertension : developed in collaboration with the ACCP , ATS , and the PHA . Circulation . 2009 ; 119 ( 16 ): 2250-2290 .
Ability to transition from treprostinil parenteral therapy 1 *