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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

© 2016 United Therapeutics Corporation . All rights reserved . US / ORE / DEC15 / 146 Printed in USA .
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
OREISIhcpJAN16
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 *
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 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 disease1-3 Early use in FC II and III1 Ability to transition from treprostinil parenteral therapy1* 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. request aN ORENITRAM representative or VISIT orenitram.com 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 OREISIhcpJAN16 Please see the Brief Summary of the Full Prescribing Information for Orenitram on the following page. For additional f&F&WB&VG&f6@wwr&VG&6"6ӃsrTDU"ӃsrӃcBӃC3rࠬ*#bVFVBFW&WWF726'&F&vG2&W6W'fVBU2$RDT3RCb&FVBU4ࠥ&VfW&V6W0&VG&6vR6W'E&W6V&6G&vR&3VFVBFW&WWF726'&F#R"6ĂwW'Vr"FRV67F2&62b&7F76ƖBG27F&RwVW2V''FW&W'FV6&RbV'&RfW'7W2V6V"&V6WF'2&7FvF2FW"ƗBVFB##Sbs24VvƖebWB44b#WW'B66V7W2V'W'FV6㠦FWfVVB6&&FvFFR45E2BFR6&7VF#b##S##ࠠ