How does the Titration Kit simplify dosing for patients?

Instead of initially receiving individual tablets in bottles, patients will have their first 3 months of Orenitram organized down to the day and individual dose. The Titration Kit contains dosing guidance and reminders for patients to know their exact morning, afternoon, and evening doses of Orenitram over the next 3 months—making titration instructions simple and less prone to errors.

What happens if a patient cannot titrate up to their next dose in the Titration Kit?

Patients should be encouraged to follow the Titration Kit schedule to achieve their target dose. If they are unable to do so, the kit includes enough tablets to adjust and/or maintain the patient’s dose for a limited time.

Who is and is not eligible to start on the Titration Kit?

Who is: De novo patients who are starting Orenitram on a TID dosing schedule for the Titration Kit. Who is not: Patients not eligible for the Titration Kit are patients who: Are starting Orenitram at a higher dose Require more dosing flexibility than the Titration Kit can accommodate

Titration Kit

Dosing Simplified

All-in-One Kit

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, halfway to the initial target TDD of 9 mg
Steadily increasing their dose every week to reach necessary exposure¹

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Patients who need more flexibility may begin Orenitram with individual strength bottles

See What’s Inside

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

4 Weekly Boxes

Each weekly box includes:

Instructions on how to take Orenitram
What to do if your patient misses a dose

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 provides information and support to confidently start 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

0.125 mg TID

Week 2

0.250 mg TID

Week 3

0.375 mg TID

Week 4

0.5 mg TID

Target TDD: 1.5mg

Support the titration process from the start

START

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

TITRATE

Continue titration^1†

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.

Continue to Stable Transitions

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.

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

Contraindications

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

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.

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.

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 at www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).

References: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2023. 2. White RJ, Grunig E, Jerjes-Sanchez C, et al. Dose-response relationship of oral treprostinil for secondary endpoints in the FREEDOM-EV study. Poster presented at: European Respiratory Society International Conference; September 27 to October 2 2019; Madrid, Spain.