Learn about Remodulin

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Remodulin (treprostinil) is approved to help patients with PAH (WHO Group 1) to diminish symptoms associated with exercise. A type of pulmonary arterial hypertension (PAH) treatment known as a prostacyclin analogue (similar to a natural substance), Remodulin is an infused (pump therapy) medicine that mimics the effects of the natural prostacyclin your body is missing.

Why Remodulin? Most widely prescribed parenteral therapy for PAH†² Prostacyclin is a natural substance found in the body that helps keep arteries (blood vessels) in the lungs open and working properly. If you have PAH, your body may not produce enough prostacyclin.
Why Remodulin? Most widely prescribed parenteral therapy for PAH†² For patients requiring transition from Flolan® (epoprostenol sodium),* Remodulin can diminish the rate of clinical deterioration. If you have PAH and your doctor wants to switch you from Flolan to Remodulin, ask him or her to review the risks and benefits of both drugs before the transition.
Why Remodulin? Most widely prescribed parenteral therapy for PAH†² It’s reassuring to know that Remodulin is the most prescribed PAH medication of its kind. Remodulin has been prescribed to patients for over ten years. And the company that makes it was inspired by the passion of one person.
Why Remodulin? Most widely prescribed parenteral therapy for PAH†² In 1993, Dr. Martine Rothblatt’s daughter was diagnosed with PAH. That year, Dr. Rothblatt began a journey of discovery that led to the creation of United Therapeutics (UT). UT is dedicated to helping PAH patients with beneficial medications and support services.

Based on data collected from U.S. prescribers.
GuidePoint Global, LLC, Subscription Survey Data for 40 PAH centers, last verified November 2012.

Selected 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 and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration
  • 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
  • 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

*The brand listed is a trademark of its respective owner and is not a trademark of United Therapeutics Corporation. The maker of this brand is not affiliated with and does not endorse United Therapeutics Corporation or its products.

Indication

Remodulin is a prescription medication used in adults with pulmonary arterial hypertension (PAH; WHO Group 1), to diminish symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. Remodulin is delivered (infused) continuously using a pump connected to a small tube that is either placed under the skin (subcutaneously [SC]) or inserted into a vein in the upper chest (intravenously [IV]). Because there are risks associated with continuous IV infusion, such as serious blood stream infections, IV infusion should be reserved for people who cannot tolerate SC infusion or for those in whom the risks are considered acceptable.

In people with PAH who need to switch from Flolan® (epoprostenol sodium), Remodulin is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

Important Safety Information

  • Continuous intravenous (IV) infusions of Remodulin are delivered using a tube placed in a central vein within the chest. This type of delivery is associated with the risk of blood stream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is the preferred type of delivery.
  • You should not stop or greatly reduce your Remodulin dose without consulting your doctor, as this may cause your PAH symptoms to worsen.
  • Other medical conditions and medicines may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug's effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.
  • If you have liver or kidney problems, your ability to tolerate Remodulin may be affected.
  • If you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs that affect liver enzymes, your doctor may need to adjust your Remodulin dosage.
  • Remodulin acts by lowering your blood pressure. In some cases your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.
  • Because Remodulin can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).
  • If you are pregnant, breast-feeding, or planning to become pregnant, talk with your doctor about whether you should take Remodulin.
  • Side Effects: In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness and swelling). These symptoms were often severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain. Other common side effects seen with either SC or IV Remodulin were headache, diarrhea, jaw pain, nausea, vasodilatation (widening of the blood vessels), and edema (swelling).

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).