Orenitram 90-Day Trial Program Terms & Conditions
Terms & conditions for trial program
By enrolling in the 90-Day Trial Program for Orenitram, you acknowledge that you currently meet the eligibility criteria and will comply with the Terms & Conditions described below:
- Only new patients with a valid prescription for an FDA-approved use of Orenitram may use this Trial Program. This Trial Program is not valid for patients transitioning to Orenitram from Tyvaso or Remodulin. By enrolling in this Trial Program, you certify that: (a) you are not currently using and have not previously used Orenitram outside of the hospital setting (i.e., “Outpatient”), and (b) you are not currently taking an inhaled or infused prostacyclin.
- Patients are not eligible to start the Trial Program in the hospital setting (i.e., “Inpatient”).
- Product cannot be shipped to a hospital, physician’s office, etc. Product must be shipped directly to the patient.
- This offer is only valid for those patients 18 years and older.
- Only 1 enrollment per patient may be redeemed under this program; no photocopies or reproductions of the enrollment form will be accepted.
- Enrollment is valid for 90 days of Orenitram at no cost to the patient.
- No claim for reimbursement for product dispensed pursuant to this Trial Program may be submitted, in whole or part, to any third-party payer, including a public or private payer.
- The prescription for the Trial Program cannot be submitted to count toward out-of-pocket costs under any prescription medicine plan.
- For Medicare patients, Trial Program product may not count toward “True Out-of-Pocket (TrOOP)” expenses.
- The Trial Program enrollment form will be accepted only at United Therapeutics Corporation’s contracted pharmacy for this Program, Lash and Group. Offer not valid if submitted to any other pharmacy.
- This enrollment form is not transferable. It is illegal for any person to sell, purchase, or trade, or offer to sell, purchase, or trade or to counterfeit this voucher.
- This 90-Day Trial Program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
- This free trial is not health insurance.
- United Therapeutics Corporation makes no express or implied guarantee that Orenitram will be covered by any third-party payer after the 90-day trial period.
- Offer good only in the United States and Puerto Rico.
- United Therapeutics Corporation reserves the right to rescind, revoke, or amend this free trial program at any time without notice.
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%).