What is FLOLAN?
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.
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How can FLOLAN improve my daily activities?
Studies have shown that some people treated with FLOLAN have reported breathing easier and feeling less tired.
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How long does it take for FLOLAN to work?
In clinical studies, improvements were seen in some people taking FLOLAN at the end of the first week of therapy. At 12 weeks of FLOLAN therapy, people showed improvements in their ability to exercise (measured by how far they could walk in 6 minutes), and a reduction in symptoms such as shortness of breath and 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.
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Who is FLOLAN for?
FLOLAN is considered the gold standard for treating severe PAH. This includes the long-term intravenous treatment of primary pulmonary hypertension (now referred to as idiopathic pulmonary arterial hypertension or IPAH) and pulmonary hypertension associated with the scleroderma spectrum of disease in patients with New York Heart Association (NYHA) Class III and Class IV symptoms who do not respond adequately to conventional therapy.
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Who should not take FLOLAN?
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 (fluid in their lungs) during the initiation of therapy. Patients should not use FLOLAN if they have an allergy to the drug or to similar compounds.
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How is FLOLAN administered?
FLOLAN is administered continuously, 24 hours a day. For this reason, people receiving FLOLAN must be fitted with a special, very thin tube (called a catheter) that allows FLOLAN to be delivered into a large vein near the heart. One end of the catheter is implanted in the chest, and the other end is attached to a small, portable pump that holds the medication. The pump must be carried or worn at all times.
To avoid potential interruptions in drug delivery, each person who is on FLOLAN therapy should have access to a backup infusion pump and intravenous infusion sets.
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How is FLOLAN prepared and stored?
FLOLAN must be mixed only with STERILE DILUENT for FLOLAN. FLOLAN must not be mixed with any other solutions or medications before or during administration.
Once mixed, FLOLAN must be protected from light and refrigerated if not used immediately. Stored FLOLAN must be used within 48 hours after it has been mixed.
FLOLAN placed in a pump for use at room temperature must be used within 8 hours. FLOLAN placed in a pump for use with a cold pouch must be used within 24 hours.
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How can I get the best results from FLOLAN therapy?
Medications work best when you take them exactly as prescribed by your doctor. You will be provided with information on how to store, prepare, and administer FLOLAN, as well as how to care for the catheter and the pump.
Don't be afraid to ask for help—work with your healthcare team to find the best way to include FLOLAN in your daily life. You may also want to involve your spouse or caregiver in learning how he or she can help you with your treatment.
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How do I get FLOLAN?
FLOLAN is available only by a doctor's prescription. FLOLAN is then mailed to your home through a specialty pharmacy. This means that your doctor will send your prescription to the specialty pharmacy and the specialty pharmacy will send FLOLAN, along with the needed supplies, directly to your home.
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How do I incorporate FLOLAN into my daily routine?
While there is a process you will need to learn in order to mix and administer FLOLAN properly, this process can be incorporated into your daily routine. Your doctor or nurse will show you how the procedure is done.
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How long will I be on FLOLAN?
FLOLAN is delivered continuously for prolonged periods of time, possibly for years, under the supervision of your doctor. It is important to not stop the delivery of FLOLAN, even for a short time, as an accidental interruption can cause serious side effects. Only a doctor can determine exactly how long FLOLAN will be needed and when it can be stopped.
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How do I recognize a problem with my FLOLAN catheter?
The following potential FLOLAN catheter emergencies are adapted from information provided by the Pulmonary Hypertension Association (PHA). For additional information please visit the PHA's website.
With proper care, you should be able to limit FLOLAN emergencies with your FLOLAN catheter; however, you should learn to recognize and respond to them if they occur. If an emergency occurs, people treated with FLOLAN should be seen by a medical professional as soon as possible. This may include calling 911 or your local emergency number. Examples of a FLOLAN emergency include:
- The catheter falls out or is pulled out
- You develop a fever
- There is drainage or oozing coming from the skin around the catheter
- The catheter is leaking or has a crack
Seek medical attention immediately if at any time you believe that FLOLAN is not being correctly pumped into your body.
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Where can I learn more about FLOLAN and PAH?
Your doctor, nurse, and pharmacy representative are the best sources of information for any questions or concerns you may have about your FLOLAN therapy or your condition.
You may also find helpful information about PAH and its treatment on these websites:
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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.
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