About United Therapeutics
Inspired by a Parent's Love...United in a Cause
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer. United Therapeutics truly is a different kind of company — it has been since the idea of the organization was first conceived. Here's why:
- The founder of United Therapeutics is the parent of a child with PAH
- Like all parents, she loves her daughter dearly. But, unlike most parents, she was fortunate enough to have the resources to create a company dedicated to finding a cure for PAH
- Until a cure is found, United Therapeutics will remain dedicated to improving the lives of patients with PAH with innovations in therapy and patient support services because that's what United Therapeutics is all about
Medicines for Life®
At United Therapeutics, we find tremendous inspiration for our work and view our products as being new beginnings for patients and doctors, with quality of life as our utmost therapeutic goal. The theme of United Therapeutics is "Medicines for Life" because all of our therapeutics address life-threatening illnesses.
REMODULIN® (treprostinil) Injection
Indication
REMODULIN is indicated for the treatment of pulmonary arterial hypertension (PAH) 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 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:
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.
