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Setting Your Patients Up for Success on Orenitram

Initiating Treatment With Orenitram

Now that you’ve identified which patients are appropriate for Orenitram, there are some important aspects of treatment to consider before initiation to ensure they get the most out of therapy.

Dosing Approaches

Select the approach that best fits your patient’s clinical needs and your preference.

90-Day Trial Program

Patients may be eligible to begin Orenitram at no cost for up to 90 days.

Referral Form

Complete the Referral Form to get your patient started on Orenitram.

Tips for Starting Patients on Orenitram With Confidence

Support a TID dosing schedule with food, every 8 hours1

Learn more about dosing and titration >

Connect patients with a Virtual Patient Educator through the Archways program

Learn about the no-cost, informative support program >

Set expectations and proactively plan for adverse effects

Learn about managing expected adverse effects >

Share cost and coverage information

Learn about the $0 co-pay assistance program >

Helping patients focus on personal goals, such as going on walks or being more active around the house, may also help strengthen their commitment to therapy.

Resources to Share With Your Patients

Managing Adverse Effects

Read about how you may prepare your patient for expected adverse effects that may occur with Orenitram.

Managing AEs

TID=3 times daily.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

Warnings and Precautions

  • Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
  • The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

Warnings and Precautions

  • Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
  • The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.

Adverse Reactions

  • In the 12-week, placebo-controlled, monotherapy study, and an event-driven placebo-controlled, combination therapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, vomiting, flushing, pain in jaw, pain in extremity, hypokalemia, abdominal discomfort, and upper abdominal pain.

Drug Interactions

  • Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.

Specific Populations

  • Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies with Orenitram in pregnant women.
  • It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.
  • Safety and effectiveness of Orenitram in pediatric patients have not been established.
  • Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients.

INDICATION

Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).

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Please see Full Prescribing Information and Patient Information for Orenitram.

For additional information, call 1-877-UNITHER (1-877-864-8437).

Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2023.