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Dosing Simplified

The All-in-One Orenitram Titration Kit

Through guidance and reminders, this kit helps your patients titrate to their target dose of Orenitram by:

  • Following a 0.125 mg TID weekly titration schedule to achieve 4.5 mg TDD in 12 weeks1
  • Steadily increasing their dose every week to reach necessary exposure1

Patients who are eligible for the Titration Kit may begin Orenitram with individual dosage strengths.

Designed to achieve 4.5 mg TDD in 12 weeks

The initial titration period is crucial to the overall success of the treatment plan. That’s why every component of the Titration Kit was designed with patients in mind.

The kit organizes dosing down to month, week, day, and individual dose, helping to simplify the titration process for patients so they can start on Orenitram with confidence.

See What’s Inside

Orenitram Titration Kit monthly shipment

3 MONTHLY SHIPMENTS

Each monthly shipment includes:

  • Information and support based on where the patient is during titration
  • A simple outline of that month’s Orenitram doses
Orenitram Titration Kit weekly boxes

4 WEEKLY BOXES

Each weekly box includes:

  • Instructions on how to take Orenitram
  • What to do if your patient misses a dose
Orenitram Titration Kit daily packs

7 DAILY PACKS

Each daily pack includes:

  • The exact morning, afternoon, and evening doses of Orenitram
  • Tools to help ensure your patient is staying on track

The Titration Kit Patient Start Guide is a practical resource designed to provide information and support for confidently starting patients on the Orenitram Titration Kit.

Download Guide

The 3-Month Titration Path

Patients will follow a 0.125 mg TID weekly titration schedule, allowing them to steadily increase their dose each week to reach necessary exposure.1

Week 1

Orenitram 0.125 mg tablet

0.125 mg
TID

Week 2

Orenitram 0.125 mg tablet
Orenitram 0.125 mg tablet

0.250 mg
TID

Week 3

Orenitram 0.125 mg tablet
Orenitram 0.25 mg dose

0.375 mg
TID

Week 4

Orenitram 0.125 mg tablet
Orenitram 0.125 mg tablet
Orenitram 0.25 mg dose

0.5 mg
TID

Support the titration process from the start

Start

Start with 0.125 mg TID
(~8 hours apart)1*

Titrate

Continue
titration1†

Monitor

Monitor for continued clinical
response and tolerability1

*You can also choose a BID (~12 hours apart) dosing schedule, starting at 0.25 mg BID and titrating in 0.25 mg BID increments as tolerated.1

†Titrate no more frequently than every 3 to 4 days.1

“We noticed in FREEDOM-EV—and even earlier—that our patients who achieve higher doses seem to have better outcomes.”

—An Orenitram prescriber

Frequently Asked Questions

Transitioning to Orenitram

See why stable patients on parenteral prostacyclin who switch to Orenitram may transition successfully.

A Confident Start

Read about the steps you and your patient may take to help them feel confident as they begin taking Orenitram.

Cost and Financial Support

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

BID=2 times daily; TDD=total daily dose; 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.