Remodulin®

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.

Remodulin is contraindicated in patients with hypersensitivity to Remodulin, its ingredients, or similar drugs. Remodulin is a potent 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. 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 problems. 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, paresthesias, hematoma and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilation, and edema.

Drug Interactions

Patients being treated for PAH are likely to be taking a number of medications, so it is possible for some of these medicines to interact with each other. For example, many patients take anticoagulants or "blood thinners" to reduce the risk of blood clots, diuretics or "water pills" and other high blood pressure medications, digitalis for the heart, and pain medications.

Reduction in blood pressure caused by REMODULIN may become more severe when taken with other drugs that also lower blood pressure. These include diuretics and other high blood pressure medications and vasodilators.

Patients who take REMODULIN might be at risk for bleeding, especially if they are also taking an anticoagulant. It is important to tell your doctor about all the drugs you take — even those you can buy without a prescription.

For complete prescribing information, please refer to the REMODULIN package insert.

REMODULIN is a registered trademark of United Therapeutics Corporation.