Important Safety Information for Remodulin

• 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).

Indication for Remodulin

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.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Full Prescribing Information for Remodulin.

For additional information, call Customer Service at 1-877-UNITHER (1-877-864-8437).

This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare professional for treatment advice.

Important Safety Information and Indication