Orenitram Titration Kit
Meet the Orenitram Titration Kit, an all-in-one kit that makes dosing simple for healthcare providers and patients to confidently start Orenitram.
Each month, patients will receive a monthly shipment of their Titration Kit.
Patients will follow a 0.125 milligram, three times a day dosing schedule and continue increasing their dose every week and titrate toward a target total daily dose of 4.5 milligrams.
How does the Orenitram Titration Kit work?
At the beginning of each month, patients will be shipped their monthly titration kit directly to their home.
Each monthly kit contains four weekly boxes and every weekly box includes seven daily packs with instructions on how to take Orenitram.
Patients can write down what food they took with their doses.
Every step of the way, patients will know their exact morning, afternoon, and evening dose.
Simply push through the blister to take out each daily dose of Orenitram.
Patients can feel confident that they're taking the right dose, staying on track with therapy, and continuing their journey toward reaching their target dose of Orenitram.
Visit www.orenitram.com to learn more about the Orenitram Titration Kit.
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.