HOW REMODULIN WORKS

Remodulin mimics some of the effects of natural prostacyclin in your body

Pulmonary arterial hypertension (PAH) is a progressive condition that affects your blood vessels, lungs, and heart. With PAH, your body may not produce enough prostacyclin, a natural substance that keeps blood vessels open and working properly. This makes it more difficult for your body to get the oxygen it needs.

CVA Vessels

Remodulin mimics some of the effects of the natural prostacyclin that your body lacks, making it easier for your heart to pump blood through your lungs. Remodulin may help improve exercise-related PAH symptoms, including shortness of breath and fatigue.

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Are you experiencing any PAH symptoms?

How are you feeling?

Symptoms

Have there been changes in your activity level lately?
Are there things you used to do that you are no longer able to do?

Review this information with your doctor and ask whether Remodulin may be right for you.

Remodulin has the potential to cause side effects, and some can be serious. Before starting Remodulin, ask your doctor to explain the benefits and risks, including risks related to the route of administration.

Selected Important Safety Information

  • 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.

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).