Setting Expectations for Adverse Effects

Considerations for a Confident Start on Orenitram

Starting Orenitram can be challenging, making it crucial to work together to proactively plan for expected adverse effects and help your patients stay on therapy.^1,2

Adverse effects seen in FREEDOM-EV included headache, diarrhea, flushing, nausea, vomiting, as well as pain in the jaw, extremities, and upper abdomen.¹

Before starting treatment¹:

Set expectations with patients on what to expect when starting treatment
Have a plan in place with both your patient and your preferred Specialty Pharmacy to help manage expected adverse effects

During administration^1,2:

Take 3 times daily with food, ~8 hours apart
Proactively use adjunctive pharmacotherapy
Reduce dosage if needed
Slow titration if needed

Headache

Acetaminophen
Tramadol^†
Opioids^†‡
Gabapentin^†
NSAIDs^†

Nausea

Take with food
Ondansetron^†
PPIs^†
Promethazine^†
Prochlorperazine^†
Metoclopramide^†

Diarrhea

Diphenoxylate/Atropine^†
Loperamide
Add fiber to diet
Dicyclomine^†

*Expert recommendations state that reassurance will suffice for flushing or jaw pain.²

^†Separate prescription required.

^‡Only recommended in severe cases.

Recommendations for adverse effect management were assembled by gathering information from a panel of Orenitram experts (N=11). This independent analysis used the Delphi process to cull panelists’ best practices for adverse effect management in patients taking Orenitram. Survey participants were from 11 centers and had a total experience of 206 patients.²

United Therapeutics does not provide medical advice. Adverse effect management strategies should be addressed in accordance with the Orenitram Full Prescribing Information and your clinical judgment.

Learn more about expert recommendations for managing expected adverse effects.

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These considerations may help address challenges during treatment and help patients reach necessary exposure.²

Hear From PAH Experts

Franck Rahaghi, MD, and Starlet Harrimon, RN, discuss how they work with patients to plan for expected adverse effects with Orenitram.

Additional Support Resources

Side Effect Patient Guide

Preparing your patients for expected adverse effects may help them start Orenitram with confidence.

90-Day Trial Program

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

Specialty Pharmacy Support

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

NSAID=nonsteroidal anti-inflammatory drug; PAH=pulmonary arterial hypertension; PPI=proton pump inhibitor.

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).

References: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2023. 2. Rahaghi FF, Feldman JP, Allen RP, et al. Recommendations for the use of oral treprostinil in clinical practice: a Delphi consensus project pulmonary circulation. Pulm Circ. 2017;7(1):167-174.