Patient Support
Living PAH
Patients taking Remodulin (treprostinil) Injection or any United Therapeutics treatment can take advantage of a comprehensive support program called Living PAH. The Living PAH program provides patients with:
- Education and treatment information
- Support and community
- Informational seminars
- The opportunity to talk to others who are living with PAH
- Personal help when they feel overwhelmed by the challenges of living with PAH
United Therapeutics encourages all patients to take advantage of Living PAH support services. To learn more, visit www.LivingPAH.com, or call the Living PAH call center at 1-877-948-9137.
The following support services are provided by United Therapeutics as part of the Living PAH Program:
PEER Network
The PEER Network is a unique program that connects people who are considering taking or have started Remodulin therapy with experienced patients called PEER Mentors. The PEER Network allows for the exchange of private, one-to-one emails through a secure Web-based system, giving patients peer support. For more information, visit www.peernetwork.net.
Patient PHorums
Patient PHorums are informational seminars designed to help patients and caregivers better understand PAH and its various treatment options that are held at different locations across the country. Each seminar is led by local PAH experts who present the latest information on the disease and treatment options, discuss current therapies and answer patient questions. It also connects you with other PAH patients and caregivers in your area so you can share thoughts and ideas. For more information, www.LivingPAH.com.
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%).
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 PAH 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 for Remodulin
- 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. Therefore, continuous subcutaneous infusion is the preferred mode of administration.
- 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. Remodulin dosage adjustment may be
necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
- 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.
- Remodulin dosage 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, vasodilatation, and edema.
For more information about REMODULIN, please see the Full Prescribing Information.
Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).