Patient Support
Remodulin® Therapy Assistance Program Consent Form
The Remodulin Therapy Assistance Program (Program) was stared by United Therapeutics to provide REMODULIN patients with non-medical assistance in support of their Remodulin therapy. This support may include providing general information about Remodulin, support group services and insurance assistance.
When you submit this form, a Remodulin Therapy Assistant (RTA) will contact you and introduce herself or himself. You will be asked general questions, such as when you started Remodulin. Your RTA will contact you periodically and you are encouraged to contact your RTA as often as you like. While some of the information you provide may be used for quality assurance within United Therapeutics, none of your personal information will be shared outside of United Therapeutics. Your personal information will be maintained in a confidential manner, in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and United Therapeutics HIPAA Compliance Policy.
By submitting this form, you are creating a no-cost relationship with your dedicated RTA at United Therapeutics. Your RTA is available to help you!
If you have any questions about the Program that you would like answered before signing this form, please feel free to contact Robert Daye, Manager of the RTA Program by calling toll free at 1-877-UNITHER or email rdaye@unither.com.
REMODULIN® (treprostinil sodium) Injection
Indication
REMODULIN is indicated for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.
In patients with pulmonary arterial hypertension requiring transition from Flolan (epoprostenol sodium), REMODULIN is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.
Important Safety Information:
Chronic intravenous infusions of REMODULIN are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. REMODULIN should be used only by clinicians experienced in the diagnosis and treatment of PAH. REMODULIN is a potent pulmonary and systemic vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. REMODULIN inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. Initiation of REMODULIN must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. Therapy with REMODULIN may be used for prolonged periods, and the patient's ability to administer REMODULIN and care for an infusion system should be carefully considered. Dose should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms. Abrupt withdrawal or sudden large reductions in dosage of REMODULIN may result in worsening of PAH symptoms and should be avoided. Caution should be used in patients with hepatic or renal insufficiency.
The most common side effects of REMODULIN included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of REMODULIN. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilation, and edema.
Please see the REMODULIN full prescribing information for further details.