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NOW AVAILABLEOrenitram Titration Kit—designed for simplicity and confidence
For each of the first 3 months of treatment, your patient will receive their monthly Orenitram Titration Kit. With dosing guidance and reminders, patients will titrate toward their target dose of Orenitram.
Each Monthly Kit includes:
- Information and support based on where the patient is during titration
- A simple outline of that month’s Orenitram doses
4 WEEKLY BOXES
Each Weekly Box includes:
- How to take Orenitram
- What to do if they miss a dose
7 DAILY PACKS
Each Daily Pack contains:
- The exact morning, afternoon, and evening doses of Orenitram
- Tools to help ensure your patient is staying on track
The 3-month titration path
The Orenitram Titration Kit provides a clear titration plan for patients to follow—steadily increasing their dose every week to reach necessary exposure.
See how the Titration Kit works
Dose initiation with Orenitram Titration Kit
5 tablet strengths and no maximum dose for dosing flexibility1
- You can also choose a BID (~12 hours apart) dosing schedule, starting at 0.25 mg BID and titrating in 0.25 mg BID increments as tolerated.1
- Titrate no more frequently than every 3 to 4 days.1
Frequently asked questions about titration with Orenitram
How does the Titration Kit simplify dosing for patients?
Instead of initially receiving individual tablets in bottles, patients will have their first 3 months of Orenitram organized by each day. The Titration Kit contains dosing guidance and reminders for patients to know their exact morning, afternoon, and evening doses of Orenitram over the next 3 months—making titration instructions simple and less prone to errors.
What happens if a patient cannot titrate up to their next dose in the Titration Kit?
Patients should be encouraged to follow the Titration Kit schedule to achieve their target dose.
If they are unable to do so, the kit includes enough tablets to adjust and/or maintain the patient’s dose for a limited time.
If the patient is unable to maintain the Titration Kit schedule, they must transition to individual strength bottles.
Who is and is not eligible to start on the Titration Kit?
Who is: De novo patients who are starting Orenitram on a TID dosing schedule are eligible for the Titration Kit.
Who is not: Patients not eligible for the Titration Kit are patients who:
- Are starting Orenitram at a higher dose
- Require more dosing flexibility than the Titration Kit can accommodate
Additional dosing considerations1
- Each dose should be taken with food
- Orenitram tablets should be swallowed whole; advise patients not to crush, split, or chew
Managing missed doses1
- 1 missed dose: instruct your patient to take the missed dose as soon as possible with food
- 2 or more missed doses: restart treatment at a lower dose and retitrate
Dose interruption or discontinuation1
Situations may arise where you need to temporarily interrupt oral therapy and use parenteral therapy. Follow these guidelines to help maintain consistent therapy:
- Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms
- For planned short-term interruption: consider a temporary infusion of subcutaneous or intravenous Remodulin® (treprostinil) Injection
- For planned discontinuation: reduce the dose in steps of 0.5 to 1 mg per day
- If dose increments are not tolerated, try slowing or temporarily stopping titration. You can also down-titrate if needed. Avoid abrupt discontinuation
Dose adjustment in patients with hepatic impairment or use with CYP2C8 inhibitors1
- In patients with mild hepatic impairment (Child Pugh Class A), start at 0.125 mg BID with 0.125 mg BID dose increments not more frequently than every 3 to 4 days
- Avoid use of Orenitram in patients with moderate hepatic impairment (Child Pugh Class B)
- Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure
- When co-administered with strong CYP2C8 inhibitors (eg, gemfibrozil), the initial dose is 0.125 mg BID with 0.125 mg BID dose increments not more frequently than every 3 to 4 days
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%).
BID=2 times daily; PAH=pulmonary arterial hypertension; TID=3 times daily.
Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2021.