Dosing Flexibility
In PAH, early treatment choices don't just affect today, they shape what's possible tomorrow.
For intermediate risk patients who need more than initial or current therapy, or refuse or are inappropriate for parenteral therapy, consider Orenitram.
Orenitram shows a consistent dose-response relationship, meaning that with increased exposure, patients may see improved clinical outcomes.
Knowing that PAH is progressive and may be unpredictable, your patient's needs can change.
Orenitram's dose-response relationship gives you the flexibility to continue titrating to meet your patient's clinical goals.
Recent studies have helped PAH experts identify the most effective dosing for their patients, such as targeting at least 9 milligrams as an initial total daily dose, which was associated with greater clinical improvement.
Yet, adverse events left unmanaged may prevent patients from reaching the dose that provides the clinical response they need.
Proactively managing side effects can help patients stay on therapy to reach an optimal dose.
Flexible dosing with Orenitram can help meet your patients' unique clinical needs.
For prostacyclin-naive patients, consider their risk profile: Initiate lower risk patients at a low dose with slow up-titration to manage side effects while progressing toward their therapeutic goal.
The Titration Kit can help you achieve this by steadily increasing your patient's dose. Patients who are ineligible for the Titration Kit may begin Orenitram with individual strength bottles.
For higher risk patients, consider parenteral therapy.
For prostacyclin-experienced patients who are hemodynamically stable on long-term parenteral therapy, transitioning to Orenitram is supported by an established formula and dose calculator.
Evidence from a peer-reviewed article supports that if patients on current therapy have reached dose limits or are at risk for discontinuation due to tolerability, they might be candidates for Orenitram.
To help support these dosing approaches, Orenitram is available in five tablet strengths, allowing you to continue titrating to maximum clinical benefit while maintaining tolerability.
Orenitram and Remodulin may provide a strong foundation for patients with PAH who are not at low risk.
For hemodynamically stable patients, clinical experience supports a transition from Remodulin to Orenitram, which helps patients continue prostacyclin treatment. With flexible dosing and proven response, Orenitram and Remodulin target PAH with a multi-modal mechanism, allowing you to support your patient's treatment journey.
See how Orenitram's dosing options can help you optimize PAH treatment at OrenitramHCP.com/dosing-orenitram
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%). IMPORTANT SAFETY INFORMATION FOR ORENITRAMContraindications
- Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.
- 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.