Flolan is a form of prostacyclin. It was approved by the FDA in 1995, and is produced by Glaxo Wellcome, Inc. It is a potent vasodilator that relaxes the blood vessels in the lungs and slows the process of scarring and cell growth within the lung? blood vessels, which prevents further narrowing. It also assists in increasing cardiac output and oxygen saturation. It improves exercise tolerance and prolongs survival in patients with PH. Although Flolan® was once used as a bridge to transplantation, it has now emerged as an alternative to transplant.

Flolan® is administered intravenously directly into the bloodstream. A surgically implanted catheter is placed in a vein in the chest and leads directly into the heart. A portable, battery-operated pump administers the Flolan. The pump is worn attached to a belt around the waist or carried in a small shoulder pack. A thin plastic cannula connects the pump to the catheter. Since the drug lasts only 3-5 minutes, it must constantly be infused: it is slowly and continuously pumped into the body through the vein in the chest.

Flolan is a powder in a glass vial. The powder must be mixed with a special solution called diluent. Flolan is mixed fresh daily and stored in a plastic cassette, which is attached to the pump. The pump is refilled with a fresh cassette every day. Once mixed, Flolan®must be kept refrigerated, so small ice packs are usually placed in the shoulder pack with the pump.

The dosage of Flolan changes frequently, especially in the early stages of treatment. The PH physician determines the dosage, and a dosage chart is usually prepared for the patient.

Side effects of Flolan can include jaw pain, headache, flushing, nausea, diarrhea, and vomiting. Central line infections occur occasionally, though many patients never experience a line infection. A line infection frequently requires hospitalization, and sometimes replacement of the central line.

Flolan was the first medication developed for the treatment of pulmonary arterial hypertension and is considered the "gold standard" of drugs because of its effectiveness and reliability.

Epoprostenol belongs to a group of agents called prostaglandins. Prostaglandins occur naturally in the body and are involved in many biological functions. Epoprostenol works by relaxing blood vessels and increasing the supply of blood to the lungs, reducing the workload of the heart.

Flolan can cost upward of $100,000 per year. Because it is considered a treatment rather than a prescription drug, insurance companies handle this differently than a prescription drug policy. It is usually covered by insurance plans, with prior approval before treatment is begun. Medicare also covers Flolan® treatment.

Hollister-Stier Laboratories, LLC

Actelion Pharmaceuticals US, Inc.

Flolan is an effective treatment for many people with PAH, but it is complex and labor-intensive to administer. It requires that all members of a patient care team understand the drug, its side effects, and its handling in order to assure safety and effectiveness.

IMPORTANT NOTE: In April 2008, a generic form of Flolan won approval in the U.S. "Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its epoprostenol, the first generic version of GlaxoSmithKline's Flolan® for Injection. Teva's approval is for the 0.5 mg base/vial and 1.5 mg base/vial strengths as well as the sterile diluent. "

• Flolan® product information, GlaxoWellcome
• FDA Drug Search: For information about this drug and any other drug approved by the U.S. FDA – patient info sheets, label info, approval history etc.
• Safety, Efficacy and Treatment Satisfaction Switching From Flolan to Remodulin