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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Flolan
Generic Name
Epoprostenol Sodium
Active Ingredient
EpoprostenolCategory
Prostacycline Vasodilator [EPC]
Salt Form
Sodium
Variants
2
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Flolan, you must consult a qualified healthcare professional.
Detailed information about Flolan
Epoprostenol is a potent prostacyclin vasodilator indicated for the treatment of Pulmonary Arterial Hypertension (PAH). It works by relaxing blood vessels in the lungs and inhibiting platelet aggregation to improve exercise capacity and survival.
Dosage for Epoprostenol is highly individualized and involves a process called titration. There is no single "standard" dose; rather, the dose is adjusted based on the patient's clinical response and their tolerance for side effects.
Epoprostenol is used in pediatric patients with severe PAH, although FDA-approved labeling for children is more limited than for adults. Pediatric dosing usually follows the same ng/kg/min weight-based protocol used in adults. Clinical studies have shown that children often require higher weight-based doses than adults to achieve similar therapeutic effects. Pediatric initiation must be performed by a pediatric cardiologist or pulmonologist experienced in PAH.
Specific dosage adjustments for renal (kidney) impairment have not been established in clinical trials. However, because Epoprostenol is rapidly hydrolyzed in the blood rather than cleared by the kidneys, major adjustments are usually not required. Clinical monitoring for fluid overload is essential.
Patients with hepatic (liver) impairment may have decreased clearance of the drug, potentially leading to higher blood levels. Healthcare providers usually titrate more slowly in these patients and monitor closely for dose-related side effects like hypotension (low blood pressure).
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Epoprostenol is administered via continuous intravenous infusion through a central venous catheter (a permanent tube inserted into a large vein in the chest). This catheter is connected to a small, portable infusion pump (such as a CADD pump).
A missed dose of Epoprostenol is a medical emergency. Because the half-life is only a few minutes, stopping the infusion can cause a sudden, severe increase in pulmonary blood pressure (rebound PAH). Symptoms of a missed dose or pump failure include shortness of breath, dizziness, and chest pain. Patients are instructed to always have a backup pump, extra batteries, and a backup supply of medication ready at all times.
Signs of an overdose are generally exaggerations of the drug's vasodilatory effects. These include:
In the event of an overdose, the infusion rate should be reduced or temporarily stopped under medical supervision. Because the drug clears so quickly, symptoms usually resolve within minutes of stopping the infusion.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without immediate medical guidance. Any interruption in therapy can be fatal.
Most patients receiving Epoprostenol will experience side effects, particularly during the dose-titration phase. These are often referred to as "prostanoid side effects."
Epoprostenol is a high-alert medication. It must only be prescribed by physicians experienced in the diagnosis and treatment of Pulmonary Arterial Hypertension. Patients must be committed to the complex task of managing a central IV line and a pump.
No formal FDA black box warning exists for Epoprostenol; however, the Warning for Sudden Interruption of Therapy is the most critical safety point. The drug has an extremely short half-life (minutes). If the infusion is stopped suddenly—due to pump failure, battery death, or a displaced catheter—it can lead to a "rebound" effect where pulmonary pressures skyrocket, potentially leading to acute right-heart failure and death.
There are no absolute drug-drug contraindications where Epoprostenol must never be used, but there are combinations that carry extreme risk.
Epoprostenol must NEVER be used in the following circumstances:
Epoprostenol is classified as Pregnancy Category B (in older FDA systems). Animal studies have not shown evidence of fetal harm. In humans, data is limited but generally positive. PAH itself carries a very high risk of maternal mortality (up to 30-50%). Therefore, clinical guidelines generally recommend continuing Epoprostenol during pregnancy if it is necessary to maintain the mother's stability. It is not known to be teratogenic (causing birth defects), but delivery must be carefully planned in a high-risk obstetric center.
It is not known whether Epoprostenol is excreted in human milk. Because many drugs are excreted in milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have been established through clinical experience and small studies. Children with PAH often have a more aggressive disease course. Epoprostenol is often used in children who are failing oral therapies. Special care must be taken regarding the child's ability to manage the pump and the risk of accidental disconnection during play or school.
Epoprostenol is a synthetic version of the naturally occurring prostaglandin, Prostacyclin (PGI2). Its primary molecular target is the IP receptor, a G-protein-coupled receptor found on the surface of vascular smooth muscle cells and platelets.
Upon binding to the IP receptor, Epoprostenol stimulates the enzyme adenylate cyclase. This enzyme converts adenosine triphosphate (ATP) into cyclic adenosine monophosphate (cAMP). The increase in intracellular cAMP leads to the phosphorylation of various proteins that ultimately cause a decrease in intracellular calcium. Lower calcium levels in the smooth muscle cells of the pulmonary arteries lead to relaxation (vasodilation). In platelets, the increase in cAMP prevents the activation and clumping (aggregation) of the cells.
Common questions about Flolan
Epoprostenol is primarily used to treat Pulmonary Arterial Hypertension (PAH), specifically WHO Group 1. It is indicated for patients with severe symptoms (Functional Class III or IV) to improve exercise capacity and survival. By widening the blood vessels in the lungs, it reduces the pressure the heart must pump against. It is often reserved for patients who do not respond well enough to oral medications. Only a specialist can determine if this intensive therapy is appropriate for a patient's specific condition.
The most common side effects are related to the drug's ability to widen blood vessels throughout the body. These include flushing of the face, throbbing headaches, and a very specific type of jaw pain that often occurs when taking the first bite of a meal. Many patients also experience nausea, diarrhea, and muscle or bone pain in the legs. These side effects are usually most intense when the dose is being increased. Most can be managed with supportive care or by slowing the rate of dose increases.
Drinking alcohol is generally discouraged while on Epoprostenol therapy. Alcohol acts as a vasodilator, meaning it widens blood vessels, which is the same thing Epoprostenol does. Combining the two can lead to a dangerous drop in blood pressure, causing severe dizziness, lightheadedness, or fainting. Furthermore, alcohol can interfere with the judgment needed to manage the complex infusion pump and sterile line care. Patients should discuss their alcohol use honestly with their healthcare provider.
Epoprostenol is often used during pregnancy because the risk of untreated Pulmonary Arterial Hypertension to the mother is extremely high. While it is classified as Category B (meaning animal studies show no harm), human data is limited. However, clinical experience suggests it is one of the safer options for managing PAH during pregnancy compared to other drugs like bosentan, which cause birth defects. Pregnant women with PAH require specialized care from a high-risk obstetric team and a PAH specialist. The drug does not appear to cause birth defects based on current evidence.
Epoprostenol begins to work almost immediately after the intravenous infusion starts. Within minutes, it begins to relax the pulmonary blood vessels and lower lung pressure. However, the full clinical benefits, such as improved walking distance and reduced shortness of breath, may take several weeks or even months to become fully apparent. This is because the dose must be slowly 'titrated' or increased over time to reach the most effective level for each individual patient. Consistency in the infusion is key to maintaining these benefits.
No, you must never stop taking Epoprostenol suddenly. Because the drug only lasts in the body for a few minutes, stopping the infusion can cause a life-threatening 'rebound' of high blood pressure in the lungs. This can lead to sudden heart failure, severe shortness of breath, and death. If your pump stops working or your IV line comes out, it is considered a medical emergency. You must always have a backup pump and supplies ready and know how to use them immediately.
A missed dose, usually caused by a pump malfunction or a disconnected IV line, requires immediate action. You should immediately switch to your backup pump and prepared medication as you were trained by your medical team. If you cannot get the infusion restarted within minutes, you must call 911 or go to the nearest emergency room. Do not wait for symptoms to appear, as the drug leaves your system very quickly. Always carry your emergency contact information and pump instructions with you.
Epoprostenol itself does not typically cause significant weight gain. However, some patients may experience fluid retention (edema) as a side effect or as a sign of their underlying heart condition. If you notice sudden swelling in your ankles or a rapid increase in weight (such as 2-3 pounds in a single day), you should contact your doctor immediately. This could indicate that your heart is struggling or that your medication needs adjustment. It is important to distinguish between fat gain and fluid buildup.
Epoprostenol can be taken with many other medications, but some require extreme caution. It is frequently used alongside oral PAH drugs like sildenafil or macitentan. However, it can interact with blood thinners (like warfarin) and antiplatelet drugs (like aspirin) to increase the risk of bleeding. It can also cause blood pressure to drop too low if taken with other blood pressure medications. You must provide your doctor with a complete list of all prescriptions, over-the-counter drugs, and herbal supplements you use.
Yes, Epoprostenol is available as a generic medication. For many years, it was only available under the brand name Flolan, but generic versions of both the original formulation and the newer, room-temperature stable formulation (Veletri) are now on the market. Generic versions are required by the FDA to be 'bioequivalent' to the brand-name versions, meaning they work the same way in the body. Your insurance provider or specialty pharmacy will determine which version you receive, but the clinical effect remains the same.
Other drugs with the same active ingredient (Epoprostenol)
> Warning: Stop taking Epoprostenol and call your doctor immediately or seek emergency care if you experience any of these.
With prolonged use, some patients may develop tolerance, meaning they need higher doses to achieve the same effect. Chronic use is also associated with thin skin or easy bruising. The most significant long-term concern is the cumulative risk of catheter-related complications, including line infections and blood clots in the large veins (venous thrombosis).
While Epoprostenol does not carry a traditional "Black Box Warning" in the sense of a boxed graphic, the FDA-approved labeling contains a prominent warning regarding the risk of rebound pulmonary hypertension. The label states that even brief interruptions in the delivery of Epoprostenol can result in rapid symptomatic deterioration and death. This warning is treated with the same clinical gravity as a black box warning by healthcare providers.
Report any unusual symptoms to your healthcare provider immediately. Most side effects can be managed by adjusting the dose titration schedule or using supportive medications (like anti-diarrheals or pain relievers).
Patients on Epoprostenol require frequent and rigorous monitoring:
Epoprostenol itself does not typically cause sedation. However, the underlying condition (PAH) can cause fainting and dizziness. Furthermore, side effects like severe headache or hypotension can impair the ability to drive. Patients should ensure they feel stable on their current dose before operating a vehicle.
Alcohol is a vasodilator (it widens blood vessels). Combining alcohol with Epoprostenol can lead to an additive effect, significantly increasing the risk of fainting, dizziness, and dangerously low blood pressure. Patients are generally advised to avoid or strictly limit alcohol consumption.
Epoprostenol must never be stopped abruptly. If the drug needs to be discontinued (for example, if a patient is transitioning to a different medication), it must be done in a hospital setting under continuous monitoring. The dose is gradually tapered down (reduced) over hours or days to allow the body to adjust.
> Important: Discuss all your medical conditions, especially any history of heart failure or bleeding disorders, with your healthcare provider before starting Epoprostenol.
Epoprostenol does not typically interfere with standard laboratory tests, though its effect on platelets will be reflected in platelet aggregation studies.
Management Strategy:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers.
These are conditions where the doctor must weigh the benefits against significant risks:
Patients who have had allergic reactions to other prostanoids (such as Treprostinil or Iloprost) should be monitored very closely, although cross-sensitivity is not guaranteed as the chemical structures differ.
> Important: Your healthcare provider will evaluate your complete medical history, including an echocardiogram to check your left-heart function, before prescribing Epoprostenol.
Clinical studies of Epoprostenol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range. There is a higher risk of falls in elderly patients, which can be dangerous if the IV line is pulled out.
No specific studies have been performed in patients with renal impairment. However, since the drug is primarily broken down in the blood, it is generally considered safe for use in patients with kidney disease, including those on dialysis. Careful monitoring of fluid balance is required, as the IV diluent adds to the patient's daily fluid intake.
Epoprostenol should be used with caution in patients with hepatic impairment. These patients may be more sensitive to the vasodilatory effects of the drug. Slower titration is recommended for patients with Child-Pugh Class B or C liver disease.
> Important: Special populations require individualized medical assessment and frequent follow-up with a PAH specialist.
| Parameter | Value |
|---|---|
| Bioavailability | 100% (Intravenous) |
| Protein Binding | Not extensively bound |
| Half-life | 2 to 6 minutes |
| Tmax | Immediate (IV) |
| Metabolism | Spontaneous hydrolysis; enzymatic degradation |
| Excretion | Renal (82% as metabolites), Fecal (4%) |
Epoprostenol is the founding member of the Prostacyclin Analog class. Related medications include Treprostinil (Remodulin), which has a longer half-life, and Iloprost (Ventavis), which is inhaled. It is also related to the oral IP receptor agonist Selexipag (Uptravi).