Now Available: Orenitram Titration Kits for Simplified Dosing – 3/1/23

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Orenitram Titration Kits for Simplified Dosing
We are pleased to announce the availability of the Orenitram Titration Kit, designed to simplify dosing and titrationso patients can reach the target dose prescribed by their healthcare provider.
*De novo patients who are starting Orenitram on a TID dosing schedule are eligible for the Titration Kit. Restrictions apply.
3 MONTHLY KITS
3 MONTHLY
KITS
4 WEEKLY BOXES PER MONTH
4 WEEKLY BOXES
PER MONTH
7 DAILY PACKS PER WEEK
7 DAILY PACKS
PER WEEK
Each Monthly Kit includes:
  • Information and support based on where a patient is during titration
  • A simple outline of a patient’s monthly Orenitram doses
Each Weekly Box includes:
  • How to take Orenitram
  • What to do if a patient missesa dose
Each Daily Pack contains:
  • The exact morning, afternoon, and evening doses of Orenitram
  • Tools to help ensure patients are staying on track
The Orenitram Titration Kit helps healthcare providers by simplifying dose escalation so theirpatients can achieve their target dose. Doses are steadily increased each week to reachnecessary exposure.
 
Orenitram Extended-Release Tablets
Description NDC
Titration KIT – Month 1 (holds 4 weekly cartons, 168 tablets) 66302-361-28
Titration KIT – Month 2 (holds 4 weekly cartons, 336 tablets) 66302-362-56
Titration KIT – Month 3 (holds 4 weekly cartons, 252 tablets) 66302-363-84
 
For more information about Orenitram Titration Kits, please contact United Therapeutics at 1-877-UNITHER (1-877-864-8437) or ManagedMarkets@unither.com
 
IMPORTANT SAFETY INFORMATION
Contraindications
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.
 
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
Warnings and Precautions (Continued)
The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.
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.
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.
Please see Full Prescribing Information and Patient Information at www.orenitram.com, or call 1-877-UNITHER (1-877-864-8437).
Reference: 1. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2021.
Orenitram is a registered trademark of United Therapeutics Corporation.
©2023 United Therapeutics Corporation. All rights reserved US/ORE/0673
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