FLOLAN SUMMARY
FLOLAN®
(epoprostenol sodium)
for Injection
FLOLAN (epoprostenol sodium) for Injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of FLOLAN contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol, 3.76 mg glycine, 2.93 mg sodium chloride, and 50 mg mannitol. Sodium hydroxide may have been added to adjust pH.
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 (see CLINICAL TRIALS IN PULMONARY HYPERTENSION).
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NEWS HIGHLIGHTSMedia Articles Related to Flolan (Epoprostenol)
ED Drug Improves Heart's Pumping Action In Young Patients With Single-Ventricle Disease
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.19]
Heart function significantly improved in children and young adults with single-ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia. Single-ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood.
Published Studies Related to Flolan (Epoprostenol)
Addition of sildenafil to long-term intravenous epoprostenol therapy in patients with pulmonary arterial hypertension: a randomized trial. [2008.10.21]
BACKGROUND: Oral sildenafil and intravenous epoprostenol have independently been shown to be effective in patients with pulmonary arterial hypertension. OBJECTIVE: To investigate the effect of adding oral sildenafil to long-term intravenous epoprostenol in patients with pulmonary arterial hypertension... CONCLUSION: In some patients with pulmonary arterial hypertension, the addition of sildenafil to long-term intravenous epoprostenol therapy improves exercise capacity, hemodynamic measurements, time to clinical worsening, and quality of life, but not Borg dyspnea score. Increased rates of headache and dyspepsia occurred with the addition of sildenafil.
Prostacyclin (epoprostenol) induces headache in healthy subjects. [2008.09.30]
The role of prostanoids in nociception is well established...
Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. [2007.09]
BACKGROUND: We determined the relative efficacy of subcutaneous (SC) treprostinil in stable World Health Organization class II and III patients transitioned from IV epoprostenol... CONCLUSIONS: SC treprostinil is effective in pulmonary arterial hypertension and prevents clinical deterioration and maintains functional status in patients transitioned from epoprostenol.
Transition from intravenous epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. [2007.03.30]
Background We determined the relative efficacy of subcutaneous (SC) treprostinil in stable (World Health Organization) WHO class II and III patients transitioned from intravenous epoprostenol. Methods An eight-week multicenter randomized study in which patients were transitioned from intravenous epoprostenol to SC treprostinil or placebo over a period of up to 14 days and monitored carefully during and after the transition period for signs of deterioration...
Small-dose epoprostenol decreases systemic oxygen consumption and splanchnic oxygen extraction during normothermic cardiopulmonary bypass. [2006.01]
Normothermic, nonpulsatile cardiopulmonary bypass (CPB) impairs systemic and splanchnic oxygen transport and increases gastrointestinal permeability...
Clinical Trials Related to Flolan (Epoprostenol)
Safety, Efficacy and Treatment Satisfaction in Patients With Pulmonary Arterial Hypertension Rapidly Switched From Epoprostenol to Remodulin [Completed]
The purpose of this 8-week study is to compare the effects of switching from therapy with
epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing
to Remodulin will have on patient satisfaction with their treatment and impact on quality of
life.
Safety, Efficacy and Treatment Satisfaction Switching From Flolan to Remodulin Using the CronoFive Ambulatory Pump in Patients With PAH [Recruiting]
The purpose of this 8-week study is to compare the effects of switching from intravenous
Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved
therapy for pulmonary arterial hypertension. Unlike Flolan, Remodulin does not need to be
mixed daily and is stable at room temperature, so there is no need for ice packs. In
addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every
8 hours (without ice packs) with Flolan. Flolan is given using a type of portable
medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given
using a smaller and lighter medication pump called the Crono Five infusion pump. This study
will also assess the effect that changing to Remodulin will have on treatment satisfaction
and patient quality of life.
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic [Recruiting]
The purpose of this 8-week study is to compare the effects of switching from therapy with
epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that
changing to Remodulin will have on patient satisfaction with their treatment and impact on
quality of life.
Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2 [Recruiting]
A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension [Completed]
This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have
been transitioned from Flolan therapy. The study consists of Screening, Baseline and
Treatment Phases.
Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the
Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and
symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion
criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the
Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which
patients will begin receiving subcutaneous study drug at a low dose determined by the
patient’s current dose of Flolan. The study drug dose will be increased gradually while the
Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will
continue until Flolan therapy has been discontinued and the patient is stable on study drug.
Patients who are transitioned off Flolan, who are stable on study drug will be discharged
from the clinic, and will continue to receive study drug on an outpatient basis. The patient
will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study
drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be
conducted and the patient will be dismissed from the study. Patients who successfully
complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the
investigator’s discretion.
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