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TO ENROLL IN THIS PROGRAM, YOUR PATIENTS MUST UNDERSTAND AND AGREE TO COMPLY WITH THE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

Eligibility Requirements for this program are:

  • Patients must be 18 years or older to use this Program
  • The Program is valid only for patients with commercial (also known as private) insurance who are taking the medication for an FDA-approved indication
  • Patients using Medicare, Medicaid, or any other state or federal government program to pay for their medications are not eligible. Patients who start utilizing government coverage during the term of the Program will no longer be eligible
  • Eligible patients must be residents of the US or Puerto Rico

Visit www.UTcopay.com for full program details and Terms and Conditions.

Patients can connect with a PEER Mentor at:
1-866-505-PEER, PEERnetwork.net

PEER Mentors are here for your patients

Whether patients have already started therapy or are still considering options for pulmonary arterial hypertension treatment, the PEER Network is here to help. PEER Mentors have firsthand experience with Remodulin and are available to share practical information and answer lifestyle questions associated with parenteral treatment. PEER Mentors are patients and caregivers who have personal experience with both delivery options for Remodulin and are happy to answer any questions patients may have.

ASSIST (Access Solutions and Support Team). Reimbursement specialists who provide information on possible financial support options for patients.

Patients can contact an ASSIST advisor by calling 1-877-UNITHER (1-877-864-8437) Monday-Friday 8:30 AM to 7 PM ET.

Remodulin® (treprostinil) Injection

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

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Remodulin® (treprostinil) Injection

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

Important Safety Information for Remodulin

Warnings and Precautions

  • Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
  • Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
  • Remodulin is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding.

Adverse Reactions

  • In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache (27% vs. 23%), diarrhea (25% vs. 16%), nausea (22% vs. 18%), rash (14% vs. 11%) jaw pain (13% vs. 5%), vasodilatation (11% vs. 5%), edema (9% vs. 3%), and hypotension (4% vs. 2%).

Drug Interactions

  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

Specific Populations

  • In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.
  • Safety and effectiveness of Remodulin in pediatric patients have not been established.
  • It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.

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