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Orenitram Side Effects Management

Setting Expectations for Adverse Effects

Considerations for a Confident Start

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

Proactive Approaches to Help Your
Patients Achieve an Optimal Dose3

Table

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.

Multidisciplinary Care Improves Patient Management

Before starting treatment1:

  • Set expectations with patients
  • Have a plan in place with both your patient and your preferred Specialty Pharmacy to help manage expected adverse effects

During administration1,2,4,5:

  • Support a TID dosing schedule with food, every 8 hours
  • Proactively use adjunctive pharmacotherapy within 24-48 hours
    of up-titration
  • Reduce dosage and slow titration
    if needed
Learn more about expert recommendations for managing expected adverse events.
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Expected Side Effects May Improve Over Time With a Proactive Management Plan3

Analysis of Patient-Reported Side Effects After 6 Months of Taking Orenitram3:

Expected side effects may improve over time8†

Headache
%
Improved
(n=44)

Treatment: Acetaminophen

Nausea
%
Improved
(n=27)

Treatment: Ondansetron‡

Diarrhea
%
Improved
(n=41)

Treatment: Loperamide

All patients reported these treatments as at least somewhat effective at month 6

†Calculated by comparing the earliest report to month 6. Patients missing an early or a month 6 report were not included in these analyses.3
‡Separate prescription required.

De-escalate any prophylactic medications and titrate to higher doses of Orenitram as side effects improve.3

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

Hear from PAH Experts

View Transcript

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.

PAH=pulmonary arterial hypertension; 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%).

OREISIhcpOCT19

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. 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. 3. Brewer J, Wilson M, Coons JC, et al. Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus. Respir Med. 2024;231:107734. 4. Kingman M, Archer-Chicko C, Bartlett M, et al. Management of prostacyclin side effects in adult patients with pulmonary arterial hypertension. Pulm Circ. 2017;7(3):598-608. 5. Imodium [package insert]. Fort Washington, PA: Johnson & Johnson Consumer Inc.; 2016.