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Stable Transitions

Stable Patients Transitioning From Remodulin to Orenitram

The Transition Study

A Closer Look at the Transition Study

For patients on parenteral prostacyclin who are appropriate for an oral prostacyclin, the Transition Study found that many could successfully switch therapies while still receiving similar clinical benefits.1,2

Study Design and Patient Criteria

Transition was a 24-week, multicenter, open-label, inpatient study that enrolled 33 patients who were1,3:

  • Diagnosed with WHO Group 1 PAH
  • On stable doses of Remodulin® (treprostinil) Injection (25–111 ng/kg/min)
  • Also receiving PDE-5i and/or ERA background therapy

The primary endpoint was safety and tolerability. Successful transition was defined as a patient no longer taking Remodulin at week 4 and maintaining Orenitram treatment at week 24 with consistent 6MWD and hemodynamics.1,3

Transitioning from Remodulin to Orenitram

MEAN DAILY DOSE ACHIEVED4*:

  • Remodulin (prior to transition): 63 ng/kg/min
  • Orenitram (end of transition): 34 mg ± 12 mg
  • Orenitram (week 24): 40 mg ± 14 mg

*Based on TID dosing subgroup (n=23).4

Majority of Stable Patients Successfully Transitioned From Remodulin to Orenitram—and All Achieved Similar Exposure1,2

%
transitioned
by week 4
%
transitioned
within 5 days
%
remained stable
on Orenitram at week 24

The most commonly reported adverse events included headache (85%), nausea (73%), flushing (70%), diarrhea (61%), fatigue (48%), and vomiting (42%).1

Learn more about transitioning your clinically stable patients to Orenitram by reading the full study.

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†Article may be restricted by a paywall for nonsubscribers.

Steps to Transition From Remodulin to Orenitram

Prior to transitioning patients, ensure they are clinically and hemodynamically stable.3

Estimate a comparable total daily dose of Orenitram using the equation below.

Determine the transition plan.

Decrease Remodulin dose while simultaneously increasing Orenitram dose.3‡

Continue to titrate Orenitram, as needed, while monitoring for tolerability.3

‡The dose of Remodulin can be reduced up to 30 ng/kg/min/day and the dose of Orenitram simultaneously increased up to 6 mg/day (2 mg TID), if tolerated.3

Dosing Calculator

When transitioning stable patients from Remodulin to Orenitram, the following equation may be used to estimate a comparable total daily dose of Orenitram3:

Remodulin to Orenitram Dose Conversion

Estimate the total dose of Orenitram

ng/kg/min
kg
x 0.0072
mg

United Therapeutics does not provide medical advice. Transitions from Remodulin should be performed in accordance with the Orenitram Full Prescribing Information and your clinical judgment.

A Confident Start

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

Managing Adverse Effects

See how to work proactively with patients to help prepare them for the challenges of expected adverse effects.

90-Day Trial Program

See how well your eligible patients may tolerate Orenitram at no cost for up to 90 days.

6MWD=6-minute walk distance; CI=cardiac index; ERA=endothelin receptor antagonist; FC=functional class; IQR=interquartile range; PAH=pulmonary arterial hypertension; PDE-5i=phosphodiesterase type 5 inhibitor; PVR=pulmonary vascular resistance; RAP=right atrial pressure; TDD=total daily dose; TID=3 times daily; WHO=World Health Organization; WU=Wood units.

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%).

OREISIhcpOCT19

Please see Full Prescribing Information and Patient Information at www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).

References: 1. Chakinala MM, Feldman JP, Rischard F, et al. Transition from parenteral to oral treprostinil in pulmonary arterial hypertension. J Heart Lung Transplant. 2017;36(2):193-201. 2. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 3. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2023. 4. Chakinala MM, Feldman JP, Rischard F, et al. Transition from parenteral to oral treprostinil in pulmonary arterial hypertension. J Heart Lung Transplant. 2017;36(suppl):1-8.