MHS, note that the study supports
“the widespread documentation of
BAC in mammography reports, improving the education of primary care
and radiology providers regarding the
link between BAC and atherosclerotic
cardiovascular disease, establishing
related standard of care and perfor-
mance measures, and stimulating
further research for establishing best
practices that can facilitate successful
translation of this widely available,
but often ignored, science.”
Margolies L, Salvatore M, Hecht HS, et al.
J Am Coll Cardiol Img. 2016;doi:10.1016/j.
jcmg.2016.02.001.
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
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 call 1-877-UNITHER (1-877-864-8437).
Women, Men with Suspected CV Disease
Report Similar Symptoms
Chest pain and shortness of breath
are the most common symptoms
reported by both women and men
with suspected heart disease, ac-
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
References: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2016.
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.
2015;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.
3/8/16 11:59 AM
cording to a study presentation at
the ACC’s 65th Annual Scientific
Session and published in JACC: Cardiovascular Imaging. The study also