| Dear [fullname,fallback=], |
|
At United Therapeutics, we are committed to improving patient treatment options for pulmonary arterial hypertension. As a result of this commitment, we are pleased to announce a new 5-mg dose strength of Orenitram. Now there are 5 dosing strengths of Orenitram available—offering you and your patients additional dosing
flexibility for the titration process.
|
Consider your patients who may benefit from the 5-mg dose strength.
If you wish to change the dosing strengths prescribed for your patient—such as going from two 2.5-mg pills to one 5-mg
pill—notify the patient's Specialty Pharmacy Services Provider. Please note, a prior authorization for the 5-mg dose strength may be required.
|
|
For more information about the 5-mg dose strength and how it may help your patients, contact your Cardiopulmonary Sales Specialist.
|
|
Sincerely,
|
[RepName,fallback=United Therapeutics]
[RepEmail,fallback=]
[RepPhone,fallback=]
|
|
ORENITRAM® (TREPROSTINIL) EXTENDED-RELEASE TABLETS
|
|
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 Full Prescribing Information and Patient Information for Orenitram.
|
|
For additional information, visit Orenitram.com or call 1-877-UNITHER (1-877-864-8437).
|
