When you prescribe FLOLAN for your patients, you are choosing the prostacyclin that has demonstrated:

Proven survival benefit in IPAH*

  • 100% survival at 12 weeks among patients defined as NYHA Class III or IV receiving FLOLAN vs. 80% survival among patients receiving conventional therapy alone2†

Increased exercise capacity:

  • FLOLAN provides significantly improved exercise capacity for patients with IPAH or APAH/SSD, as measured from baseline by 6-minute walk distance at 12 weeks2

Improvements in functional class:

  • 40% of patients with IPAH improved in New York Heart Association (NYHA) class after 12 weeks of treatment with FLOLAN plus conventional therapy2†‡
  • 38% of patients with APAH/SSD improved in NYHA class after 12 weeks of treatment with FLOLAN plus conventional therapy3†§

*No statistically significant difference in survival over 12 weeks among patients with APAH/SSD treated with FLOLAN compared with those receiving conventional therapy alone.3
†Conventional therapy consisted of anticoagulants, oral vasodilators, supplemental oxygen, digoxin, and/or diuretics.4
‡Analysis based on patients alive and not transplanted at 12 weeks (n=40).
§Analysis based on intention to treat (n=56).

References: 1. Lee SH, Rubin LJ. Current treatment strategies for pulmonary arterial Hypertension. J Intern Med. 2005;258(3):199–215. 2. Barst RJ, Rubin LJ, Long WA, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1996;334(5):296-301. 3. Badesch DB, Tapson VF, McGoon MD, et al. Continuous intravenous epoprostenol for pulmonary hypertension due to scleroderma spectrum of disease. Ann Intern Med. 2000;132(6):425-434.
4. FLOLAN [Prescribing Information]. Research Triangle Park, NC: GlaxoSmithKline; January 2008.

INDICATION: FLOLAN is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.


IMPORTANT SAFETY INFORMATION:
Chronic use of FLOLAN is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.

FLOLAN should not be used chronically in patients who develop pulmonary edema during dose initiation.

FLOLAN must be reconstituted only as directed using STERILE DILUENT for FLOLAN. FLOLAN must not be reconstituted or mixed with any other parenteral medications or solutions prior to or during administration.

Abrupt withdrawal or reductions in delivery of FLOLAN, as well as overdoses, may result in hemodynamic instability, including rebound pulmonary hypertension or fatal hypotension.

FLOLAN should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension.

FLOLAN is a potent inhibitor of platelet aggregation. Therefore, an increased risk for hemorrhagic complications should be considered, particularly for patients with other risk factors for bleeding.

During chronic use, FLOLAN is delivered continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, anticoagulant therapy should be administered to PPH and PH/SSD patients receiving FLOLAN to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. In order to reduce the risk of infection, aseptic technique must be used in the reconstitution and administration of FLOLAN as well as in routine catheter care. Dosage of FLOLAN during chronic use should be adjusted at the first sign of recurrence or worsening of symptoms.

Chronic adverse events reported during clinical trials include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness.

Serious adverse events have been reported during post-approval use of FLOLAN.
These include sepsis, anemia, hypersplenism, thrombocytopenia, pancytopenia, splenomegaly, and hyperthyroidism.

Excessive doses of FLOLAN may acutely result in systemic hypotension, tachycardia, headache, flushing, nausea and vomiting, diarrhea; excessive doses administered chronically can lead to the development of a hyperdynamic state and high-output cardiac failure.*

*Badesch DB, Abman SH, Ahearn GS, et al. Medical therapy for pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004;126(1, suppl):35S-62S.

Please click here for full prescribing information