Who can be treated with FLOLAN?
FLOLAN is a medication developed to treat PAH. It is considered the gold standard therapy for treating people with severe PAH—specifically, people with IPAH or pulmonary arterial hypertension associated with the scleroderma spectrum of disease (APAH/SSD) who have New York Heart Association (NYHA) Class III or Class IV symptoms and who do not respond adequately to conventional therapy.
FLOLAN has been used for many years to treat people with the following types of PAH:
- Idiopathic pulmonary arterial hypertension (IPAH): This is a term that doctors use to describe PAH for which the cause is unknown, unexplained, or not caused by another disease.
- Pulmonary arterial hypertension associated with the scleroderma spectrum of disease (APAH/SSD): This term is used by doctors to describe PAH that is associated with a disease called scleroderma.
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How Flolan is thought to work
In pulmonary arterial hypertension (PAH), the pulmonary arteries become much narrower than usual. While the exact way FLOLAN works is not known, studies have shown that FLOLAN can help make it easier for blood to flow through the pulmonary arteries, which may help the heart pump blood more efficiently and may help reduce the symptoms of PAH.
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How can people expect to feel on FLOLAN?
In clinical studies, people with PAH who took FLOLAN experienced improvements in exercise capacity, measured by how far they could walk in 6 minutes, and the degree to which they felt short of breath or experienced fatigue.
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What are the risks and side effects of FLOLAN?
As with all medications, there are possible risks and side effects associated with FLOLAN. Any sudden interruption of therapy with FLOLAN, even for a brief period, may result in symptoms associated with rebound pulmonary hypertension, including difficulty breathing, dizziness, and a lack of energy. In severe cases, rebound pulmonary hypertension can lead to death.
FLOLAN can pose an increased risk for bleeding complications, particularly in people who have other risk factors for bleeding.
The most common side effects associated with FLOLAN include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety, and nervousness.
Serious adverse events have been reported during chronic infusion of FLOLAN. These include bloodstream infection, anemia, overactivity and enlargement of the spleen, a reduction in red and white blood cells and platelets, and overactivity of the thyroid gland.
Some side effects that may be caused by excessive doses of FLOLAN include flushing, headache, low blood pressure, a rise in heart rate, nausea, vomiting, and diarrhea.
Over time, excessive doses of FLOLAN can weaken the heart by causing it to pump too large a volume of blood.
Other side effects can occur, and patients should let their healthcare professional know of any side effects that they are experiencing while on therapy with FLOLAN.
Please see the full prescribing information, including Important Safety Information, for a complete list of the risks and side effects associated with FLOLAN.
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Specialty pharmacy
FLOLAN is available only by prescription. FLOLAN is available only through the Accredo specialty pharmacy. This means that your doctor will send your prescription to Accredo, and the specialty pharmacy will then send the medication and supplies directly to your home.Â
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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.
Pulmonary hypertension is high blood pressure in the arteries of the lungs.
IMPORTANT SAFETY INFORMATION: FLOLAN should not be used by patients with congestive heart failure due to severe left ventricular systolic dysfunction. It should also not be used by patients who develop pulmonary edema, or fluid in their lungs, during the initiation of therapy.
Patients should not use FLOLAN if they have an allergy to the drug or similar compounds.
FLOLAN should only be mixed with STERILE DILUENT for FLOLAN. FLOLAN must not be mixed with any other medications or solutions prior to or during administration.
Any sudden interruption of therapy with FLOLAN, even for a brief period, may result in symptoms associated with rebound pulmonary hypertension, including difficulty breathing, dizziness, and a lack of energy. In severe cases, rebound pulmonary hypertension can lead to death.
FLOLAN can pose an increased risk for bleeding complications, particularly in people who have other risk factors for bleeding.
The most common side effects associated with FLOLAN include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety, and nervousness.
Serious adverse events have been reported during post-approval use of FLOLAN. These include bloodstream infection, anemia, overactivity and enlargement of the spleen, a reduction in red and white blood cells and platelets, and overactivity of the thyroid gland.
Some side effects that may be caused by excessive doses of FLOLAN include flushing, headache, low blood pressure, a rise in heart rate, nausea, vomiting, and diarrhea.
Over time, excessive doses of FLOLAN can also weaken the heart by causing it to pump too large a volume of blood.
Other side effects can occur and patients should let their healthcare professional know of any side effects that they are experiencing when on therapy with FLOLAN.
Please click here for full prescribing information.
