Patient leaflet - Epoprostenol 1.5 mg powder for solution for infusion
1. What Epoprostenol is and what it is used for
Epoprostenol contains the active substance epoprostenol which belongs
to a group of medicines called prostaglandins, which stop blood from
clotting and widen the blood vessels.
Epoprostenol is used to treat a lung condition called ‘pulmonary arterial
hypertension’. This is where the pressure is high in the blood vessels in the
lungs. Epoprostenol widens the blood vessels to lower the blood pressure
in the lungs.
Epoprostenol is also used to prevent blood clotting during kidney dialysis
in emergency situations when heparin cannot be used.
2. What you need to know before you use Epoprostenol
Do NOT use Epoprostenol
if you are allergic to epoprostenol or any of the other ingredients of
this medicine (listed in section 6)
- if you have heart failure
if you start to develop a build-up of fluid in your lungs causing
breathlessness after starting this treatment.
If you think any of these apply to you, don’t use Epoprostenol until you
have checked with your doctor.
Warnings and precautions
Talk to your doctor before treatment with Epoprostenol
if you bleed easily (for example from your nose).
Skin damage at the injection site
Epoprostenol is injected into a vein. It is important that the medicine does
not leak out of the vein into the surrounding tissue. If it does, the skin
could be damaged. The symptoms of this are:
- tenderness
- burning
- stinging
- swelling
- redness.
This may be followed by blistering and shedding of the skin. While you are
being treated with Epoprostenol, it is important that you check the
injection area.
Contact the hospital immediately for advice if the area becomes sore,
painful or swollen or you notice any blistering or shedding of the skin.
Effect of Epoprostenol on blood pressure and heart rate
Epoprostenol can cause your heart to beat faster or slower. Also your blood
pressure can become too low. While you are being treated with
Epoprostenol your heart rate and blood pressure will be checked. The
symptoms of low blood pressure include dizziness and fainting.
Tell your doctor immediately if you get these symptoms. Your dose may
need to be reduced or your infusion stopped.
Children and adolescents
The safety and efficacy of Epoprostenol in children have not yet been
established.
Other medicines and Epoprostenol
Tell your doctor or nurse if you are using, have recently used or might use
any other medicines.
Some medicines may affect how Epoprostenol works, or make it more
likely that you’ll have side effects.
Epoprostenol can also affect how some other medicines work if taken at
the same time. These include:
- medicines used to treat high blood pressure
- medicines used to prevent blood clots
- medicines used to dissolve blood clots
medicines to treat inflammation or pain (also called ‘NSAIDs’),
for example ibuprofen
- digoxin (used to treat heart disease).
Tell your doctor or nurse if you are taking any of these.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
treatment with this medicine.
It is not known whether the ingredients of Epoprostenol can pass into
breast-milk. You should stop breastfeeding your child during
treatment with Epoprostenol.
Driving and using machines
Your treatment may have an effect on the ability to drive or use machinery.
Don’t drive or use machines if you’re feeling unwell.
Epoprostenol contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is
to say essentially ‘sodium- free’.
The diluted solution of Epoprostenol (pH 12) must not be used with
administration materials containing polyethylene terephthalate (PET) or
polyethylene terephthalate glycol (PETG).
3. How to use Epoprostenol
Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor or nurse if you are not sure.
Epoprostenol comes as a powder in a small glass vial. The powder needs to be dissolved before use.
Epoprostenol should not be given as a quick injection into your vein. It should always be given as an intravenous infusion (drip).
Your doctor will decide how much Epoprostenol is right for you. The amount you are given is based on your body weight, and your type of illness. Your dose may be increased or decreased depending on how well you respond to treatment.
Epoprostenol is given by slow infusion (drip) into a vein.
Pulmonary arterial hypertension
Your first treatment will be given to you in a hospital. This is because your doctor needs to monitor you and find the best dose for you.
You will start with an infusion of Epoprostenol. The dose will be increased until your symptoms are relieved and any side effects are manageable. Once the best dose has been found, a permanent tube (line) will be fitted into one of your veins. You can then be treated using an infusion pump.
Kidney dialysis
You will be given an infusion of Epoprostenol for the duration of your dialysis.
Using Epoprostenol at home (only for treatment of pulmonary arterial hypertension)
If you are treating yourself at home, your doctor or nurse will show you how to prepare and use Epoprostenol. They will also advise you how to stop treatment if necessary. Stopping Epoprostenol must be done gradually. It is very important that you follow all their instructions carefully.
Epoprostenol comes as a powder in a glass vial. Before use, the powder needs to be dissolved in a liquid. The liquid does not contain a preservative. If you have any of the liquid left over, it must be thrown away.
Looking after the injection line
If you have been fitted with a ‘line’ into a vein it is very important to keep this area clean, otherwise you could get an infection. Your doctor or nurse will show you how to clean your ‘line’ and the area around it. It is very important that you follow all of their instructions carefully. It is also very important that you carefully follow all instructions regarding the change of the pump drug delivery reservoir (cassette) and that you always use an extension set with an in-line filter, as instructed by your doctor to reduce the risk of an infection.
If you use more Epoprostenol than you should Seek urgent medical attention if you think you have used or been given too much Epoprostenol. Symptoms of overdose may include headache, nausea, vomiting, fast heart rate, warmth or tingling, or feeling like you might pass out (feeling faint/dizziness).
If you forget to use Epoprostenol
Do not use a double dose to make up for a forgotten dose.
If you stop using Epoprostenol
Stopping Epoprostenol must be done gradually. If the treatment is stopped too quickly you may get serious side effects, including dizziness, feeling weak and breathing difficulties. If you have problems with the infusion pump or an injection line that stops or prevents treatment with Epoprostenol, contact your doctor, nurse or hospital immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you get any of the following signs of infection of the blood, low blood pressure or serious bleeding:
You feel that your heart is beating faster, or you have chest pain or
shortness of breath
- You feel dizzy or feel faint, especially on standing
- You have fevers or chills
You have more frequent or longer periods of bleeding, for example
nose bleeding
The injection site becomes sore, painful or swollen or you notice any
blistering or shedding of the skin (see Section 2).
Other possible side effects
Very common (may affect more than 1 in 10 people)
- headache
- jaw pain
- pain
- being sick (vomiting)
- feeling sick (nausea)
- diarrhoea
- redness of your face (flushing).
Common (may affect up to 1 in 10 people)
- infection of the blood (septicaemia)
- heart beating faster
- slow heart beat
- low blood pressure
bleeding at various sites and bruising more easily than normal,
for example from the nose or gums
- stomach discomfort or pain
- chest pain
- joint pain
- feeling anxious, feeling nervous
- rash
- pain at the injection site
decrease in the number of blood platelets (cells that help the blood to
clot). This may show up in blood tests.
Uncommon (may affect up to 1 in 100 people)
- sweating
- dry mouth.
Rare (may affect up to 1 in 1000 people)
- infection at the injection site.
Very rare (may affect up to 1 in 10,000 people)
- feeling of tightness around the chest
- feeling tired, weak
- feeling agitated
- pale skin
- redness at the injection site
- overactive thyroid gland
- blockage of the injection catheter.
Not known (frequency cannot be estimated from the available data)
- enlarged or overactive spleen
- build up of fluid in the lungs (pulmonary oedema) - increase in sugar (glucose) in the blood
swelling due to build up of fluid around the stomach - too much pumping of blood from the heart leading to shortness of
breath, fatigue, swelling of the legs and abdomen due to fluid build-up, persistent cough.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Epoprostenol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the vial label and carton after EXP. The expiry date refers to the last day of that month.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
The reconstituted solution should be further diluted to the final concentration within one hour of reconstitution (see Information intended for medical or healthcare professionals).
For storage conditions after reconstitution and dilution of the medicine see Information intended for medical or healthcare professionals.
Do not use this medicine if you notice any particles in the reconstituted solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Epoprostenol contains
Epoprostenol 0.5 mg, powder for solution for infusion:
The active substance is epoprostenol (as epoprostenol sodium).
Each vial contains 0.531 mg epoprostenol sodium equivalent to 0.5 mg epoprostenol.
One ml of reconstituted solution contains 0.1 mg epoprostenol (as epoprostenol sodium).
Epoprostenol 1.5 mg, powder for solution for infusion:
The active substance is epoprostenol (as epoprostenol sodium).
Each vial contains 1.593 mg epoprostenol sodium equivalent to 1.5 mg epoprostenol.
One ml of reconstituted solution contains 0.3 mg epoprostenol (as epoprostenol sodium).
The other ingredients are glycine, sucrose and sodium hydroxide (for pH adjustment).
What Epoprostenol looks like and contents of the pack
White to off-white powder in a clear glass vial with a rubber stopper and an aluminium flip-off cap.
Each pack contains one vial holding 0.5 mg powder.
Each pack contains one vial holding 1.5 mg powder.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Italy Epoprostenolo SUN Netherlands Epoprostenol SUN Spain Epoprostenol SUN United Kingdom (Northern Ireland) Epoprostenol
This leaflet was last revised in December 2021
PL-000096
Rev. 1.0