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Orenitram 90 Day Trial Program logo

Why Should My Patient Enroll?

  • Allows you to assess how well your eligible* patients tolerate Orenitram at no cost for up to 90 days
  • Delivers the medication to the patient quickly, in many cases less than 1 week
  • Offers Specialty Pharmacy support, with virtual nurse visits to help the patient throughout the program
  • Patients may also start on the Orenitram Titration Kit, which helps simplify dosing during the 90-day trial

Patients are under no obligation to continue taking Orenitram after the trial period.

How to Get Started

Check your patient’s eligibility for the program

*Eligibility for this program is limited to patients with PAH (WHO Group 1) who are not currently using and have not previously used Orenitram, and are not currently taking an inhaled or infused prostacyclin. Patients transitioning from another treprostinil medication are not eligible for this program. For other eligibility criteria, see full Terms and Conditions on the Enrollment Form.

Complete the Orenitram 90-Day Trial Program Enrollment Form in its entirety and fax to ASSIST at 1-800-380-5294—or complete electronically using iAssist.com.

Answer phone calls to provide missing and/or necessary information to ASSIST or Lash Group Specialty Pharmacy.

TO CONTACT ASSIST, CALL 1-877-UNITHER (1-877-864-8437).

TO CONTACT LASH GROUP SPECIALTY PHARMACY, CALL 1-855-477-9463.

Continuing Your Patient on Orenitram After the
90-Day Trial Period

Around day 60, ASSIST will reach out to determine if you wish to continue or discontinue Orenitram as part of your patient’s treatment plan.

If you decide to continue your patient on Orenitram beyond the 90-day trial, an Orenitram Referral Form must be submitted to ASSIST.

Submit the Referral Form to ASSIST as soon as possible to avoid a lapse in your patient’s treatment. ASSIST will then complete all required steps to process your referral and help your patient continue taking Orenitram.

Additional Support Resources

Cost and Financial Support

See how United Therapeutics may help with cost assistance and support for patients taking Orenitram.

Specialty Pharmacy Support

Read about how Specialty Pharmacies may help your patients access Orenitram, schedule nurse visits, and much more.

Archways Program

Discover how a United Therapeutics Virtual Patient Educator may help your patients get started on Orenitram.

PAH=pulmonary arterial hypertension; WHO=World Health Organization.

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).