How does it work?
Flolan infusion contains the active ingredient epoprostenol sodium, which is a type of medicine called a prostaglandin. It acts as an anti-clotting agent (anticoagulant). It also dilates the blood vessels.
Epoprostenol is used mainly in a condition called pulmonary arterial hypertension (PAH). In this serious condition the pulmonary arteries that carry blood from the heart to the lungs become stiff and thickened. This increases the pressure of the blood in these arteries and makes it very difficult for the heart to pump blood to the lungs. This problem causes shortness of breath, especially during any sort of exercise, and can also result in weakening of the right side of the heart.
Epoprostenol works in this condition by dilating (widening) the pulmonary arteries. This lowers the pressure in these arteries and makes it easier for the heart to pump blood through them.
Epoprostenol also interferes with the body's blood clotting mechanism. It prevents blood cells called platelets from clumping together inside the blood vessels. Platelets are the blood cells that start off the process of blood clotting. This process is complicated and begins when platelets clump together and produce chemicals that attract more platelets and clotting factors to the area, eventually forming a solid blood clot. By stopping the platelets clumping together, epoprostenol prevents blood clots forming.
People with PAH are at increased risk of getting a blood clot in a blood vessel (thomboembolism) and this feature of epoprostenol helps blood clots from developing in these people.
Epoprostenol only acts for a short period of time after it has been administered, so treatment with it for PAH must be continuous.
The short-acting feature of epoprostenol makes it useful in situations where clotting needs to be prevented immediately but not in the long-term. It is sometimes used during kidney dialysis to prevent the blood from clotting as it passes through the dialysis machine. It is not a standard anticoagulant and is only used in this situation when heparin (the more commonly used anticoagulant for this procedure) can't be used.
What is it used for?
- A serious medical condition called pulmonary arterial hypertension, in which there is raised blood pressure in the arteries that lead from the heart to the lungs. This medicine is usually reserved for very severe cases of PAH, or for when other treatments have not been effective. This is because once treatment with this medicine is started you will usually need to continue it for the rest of your life. Stopping the medicine is likely to make the condition come back rapidly.
- Preventing blood from clotting when it is filtered through an 'artificial kidney' (haemodialysis) machine as part of the management of kidney failure. This medicine is only used when an anticoagulant called heparin can't be used.
How is this treatment given?
- Flolan is given as a continuous drip into a vein (intravenous infusion) when treating PAH. A vein in your arm or in your chest may be used.
- The treatment for PAH will be started in hospital. Once the right dose for you is established, it may be possible, with special training and equipment, for you or your carer to learn how to administer the medicine yourself at home. In this situation the medicine will be given using a small, portable machine called an infusion pump, which continuously delivers the medicine through a tube into one of your veins, usually in your chest. This permanent tube is often called a central line.
- To stop blood clots forming during kidney dialysis you will be given a drip of the medicine into one of your veins for the duration of the dialysis.
- If epoprostenol leaks out of the vein into which it is given and into the surrounding tissues, it can cause damage to the tissue there. For this reason, it is important to tell your doctor or nurse straight away if you notice any tenderness, burning, stinging, swelling or redness around the vein, blistering or shedding of the skin, or if you notice any fluid leaking out of the infusion site while the medicine is being given.
- Your blood pressure and heart rate (pulse) should be regularly monitored during treatment with this medicine. Tell your doctor if you feel dizzy or faint during treatment, or if you notice your heart beating faster or slower than usual.
- Once you start treatment with this medicine for PAH you must not suddenly stop treatment, unless there is a life-threatening reason. Stopping the treatment can cause a sudden rebound of your condition, with increased breathing difficulties, dizziness and weakness, and can be fatal. If you have any problems with your infusion pump or injection line that stops or prevents treatment with Flolan, contact your doctor, nurse or hospital immediately. If treatment needs to be stopped for any reason this must be done gradually, under the supervision of your doctor.
Use with caution in
- Elderly people.
- People with coronary heart disease.
- People who are at risk of bleeding, for example due to blood clotting disorders such as haemophilia, or treatment with anticoagulant medicines such as warfarin or heparin.
- People on a controlled-sodium diet (Flolan infusion contains sodium).
Not to be used in
- People with congestive heart failure caused by a problem with the left side of the heart.
- People who develop a build-up of fluid in the lungs (pulmonary oedema) when medicine is started.
- This medicine is not recommended for children or adolescents under 18 years old, as its safety and effectiveness have not been established in this age group.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. It should be used with caution during pregnancy and only if the benefits outweigh any potential risks to the developing baby. Seek medical advice from your doctor if you think you could be pregnant while having treatment with this medicine.
- It is not known if this medicine passes into breast milk. The manufacturer recommends that mothers who need treatment with this medicine should avoid breastfeeding. Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- Increased blood flow to the skin on the face (facial flushing).
- Feeling or being sick.
- Jaw pain.
Common (affect between 1 in 10 and 1 in 100 people)
- Pain at the infusion site.
- Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
- Reduced numbers of blood cells called platelets in the blood (thrombocytopenia).
- Bleeding in various areas of the body, such as the nose, lungs, gut, brain.
- Slower than normal heartbeat (bradycardia).
- Faster than normal heartbeat (tachycardia).
- Low blood pressure (hypotension).
- Abdominal cramps or discomfort.
- Pain in the joints.
- Chest pain.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
Very rare (affect less than 1 in 10,000 people)
- Redness at the infusion site.
- Overactive thyroid gland (hyperthyroidism).
- Looking pale.
- Chest tightness.
- High blood sugar level (hyperglycaemia).
- Build-up of fluid in the lungs (pulmonary oedema).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.
If other medicines that dilate blood vessels are used in combination with epoprostenol this may result in excessive lowering of blood pressure, which could cause dizziness or fainting. Other medicines that dilate blood vessels include the following:
- alpha blockers such as prazosin, doxazosin, and terazosin
- most medicines for high blood pressure
- nitrates such as glyceryl trinitrate or isosorbide mononitrate
- tadalafil .
There may be an increased risk of bleeding if any of the following medicines are used in combination with epoprostenol:
- anticoagulant medicines to prevent blood clotting, for example warfarin, heparin, dabigatran (you may need to have extra monitoring of your blood clotting if you are taking one of these with epoprostenol)
- antiplatelet or 'blood-thinning' medicines, for example clopidogrel, dipyridamole, low-dose aspirin
- non-steroidal anti-inflammatory drugs (NSAIDs), for example aspirin, ibuprofen, diclofenac, naproxen (you should only take these types of painkiller on the advice of your doctor).
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain epoprostenol as the active ingredient.