Set patient expectations for therapy and proactively manage side effects1,2
Setting patient expectations for adverse events with Orenitram and developing a management plan to mitigate their effects may help patients stay with therapy1,2
- Strategies to help patients manage adverse events and achieve a higher maximum dose2,3
- Take Orenitram with food
- Reduce dosage
- Slowing titration
- Proactive use of adjunctive pharmacotherapy
Delphi Consensus Recommendations for Select Adverse Events Management2*
Recommendations to aid in side effect management were assembled using the Delphi process, a structured communication technique that gathered information from a panel of respondents with expertise using Orenitram (N=11). In this independent analysis, the Delphi process was used to investigate best practices used by panelists for side effect management in patients treated with Orenitram. Survey participants were from 11 centers and had a total experience of 206 patients.2
- Consensus recommendations state that reassurance will suffice for flushing or jaw pain.2
- Separate prescription required.
- Only recommended in severe cases.
Side effect management strategies should be dealt with in accordance with the Orenitram Full Prescribing Information and your clinical judgment
Important Safety Information
- 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.
- 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.
- Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.
- 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.
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%).
NSAID=nonsteroidal anti-inflammatory drug; PPI=proton pump inhibitor.
References: 1. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 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. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2019.