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VELETRI 1.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): EPOPROSTENOL

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Package leaflet: Information for the user
Veletri 1.5 mg, Powder and Solvent for Solution for Infusion
Epoprostenol
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
What Veletri is and what it is used for
2.
What you need to know before you take Veletri
3.
How to take Veletri
4.
Possible side effects
5.
How to store Veletri
6.
Contents of the pack and other information

1.

What Veletri is and what it is used for

Veletri contains the active substance epoprostenol, which belongs to a group of medicines called
prostaglandin, which stops blood from clotting and widens the blood vessels.
Veletri 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. Veletri widens the blood vessels to lower the blood pressure in the
lungs.
Veletri is used to prevent blood clotting during kidney dialysis when heparin cannot be used.

2.

What you need to know before you use Veletri

Do not use Veletri

if you are allergic to Veletri 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 take Veletri until you have checked with your doctor.
Warnings and precautions
Talk to your doctor before using Veletri.
Veletri contains sodium (less than 1 mmol sodium (23 mg) per dose)
Before you are given Veletri your doctor needs to know:

if you have any problems with bleeding.
Skin damage at the injection site

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Veletri 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 Veletri, 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.
Effect of Veletri on blood pressure and heart rate
Veletri can cause your heart to beat faster or slower. Also your blood pressure can become too low. While
you are being treated with Veletri, your heart rate and blood pressure will be checked. The symptoms of low
blood pressure include dizziness and fainting.
Tell your doctor if you get these symptoms. Your dose may need to be reduced or your infusion stopped.
Children and adolescents
The safety and efficacy of Veletri in children have not yet been established.
Other medicines and Veletri
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Some medicines may affect how Veletri works, or make it more likely that you’ll have side effects. Veletri
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’)

digoxin (used to treat heart disease).
Tell your doctor or pharmacist if you are taking any of these.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine as your symptoms could worsen during
pregnancy.
It is not known whether the ingredients of Veletri can pass into breast-milk. You should stop breastfeeding
your child during treatment with Veletri.
Driving and using machines
Your treatment may have an effect on the ability to drive or use machinery.
Don’t drive or use machines unless you’re feeling well.

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3.

How to take Veletri

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Veletri comes as a powder in a small glass vial. The powder needs to be dissolved before use.
Veletri should not be given as a quick injection into your vein. It should always be given as an intravenous
infusion.
Your doctor will decide how much Veletri 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.
Veletri 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 Veletri. 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 Veletri for the duration of your dialysis.
Using Veletri 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 Veletri.
They will also advise you how to stop treatment if necessary. Stopping Veletri must be done gradually. It is
very important that you follow all their instructions carefully.
Veletri 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 take more Veletri than you should
Seek urgent medical attention if you think you have used or been given too much Veletri. 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 take Veletri
Do not take a double dose to make up for a forgotten dose.
If you stop taking Veletri
Stopping Veletri 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 Veletri, contact your doctor, nurse or
hospital immediately.

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If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects
These 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 side effects
These 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
Common side effects that may show up in blood tests

decrease in the number of blood platelets (cells that help the blood to clot)
Uncommon side effects
These may affect up to 1 in 100 people:

sweating

dry mouth
Rare side effects
These may affect up to 1 in 1000 people:

infection at the injection site
Very rare side effects
These 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
Other side effects
It is not known how many people are affected by:
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build up of fluid in the lungs (pulmonary oedema)
increase in sugar (glucose) in the blood

Reporting of side effects
Tell your doctor or nurse immediately, as these may be signs of infection of the blood or 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.
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 (see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5.

How to store Veletri

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 carton powder vial and solvent vial after
EXP. The expiry date refers to the last day of that month.
This medicinal product (powder for solution for infusion/powder and solvent for solution for infusion) does
not require any special temperature storage conditions. Do not freeze.
The solvent contains no preservative; consequently, a vial should be used once only and then discarded.
The reconstituted solution should be immediately further diluted to the final concentration (see section 7).
For storage conditions after reconstitution and dilution of the medicinal product see section 7.
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 Veletri contains
Veletri 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).
Veletri 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 Sucrose, Arginine and Sodium Hydroxide (for pH adjustment).

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Solvent:
Each vial of solvent contains 100 mL water for injection
What Veletri 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 0.5 mg powder.
Each pack contains one vial 1.5 mg powder.
Each pack contains one bottle of 100 mL of solvent. The solvent is a clear, colourless solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Actelion Registration Ltd
Chiswick Tower 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom
Manufacturer:
Actelion Pharmaceuticals Deutschland GmbH
Konrad Goldmann Strasse 5b
79100 Freiburg
Baden-Württemberg
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Veletri
This leaflet was last revised in 17/08/2015
----------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:

7.

INFORMATION FOR HEALTHCARE PROFESSIONALS

Renal Dialysis
There are 2 packs available for use in the treatment of renal dialysis:

One vial containing sterile, freeze-dried Veletri equivalent to 0.5 mg Veletri, supplied with one
100 mL bottle of solvent.

One vial containing sterile, freeze-dried Veletri equivalent to 0.5 mg Veletri supplied alone.
Reconstitution:
Withdraw 5 mL of diluent into a sterile syringe, inject the contents of the syringe into the vial containing
Veletri and shake gently until the powder has dissolved. The reconstituted solution should be examined prior
to further dilution. Its use is forbidden in the presence of discolouration or particles. Any unused
reconstituted solution should be disposed of in accordance with local requirements.
Dilution:
The reconstituted solution should be immediately further diluted to the final concentration. Further dilution
should be performed with the same diluent as used for reconstitution of the sterile, lyophilised powder.

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Calculation of infusion rate:
Infusion rates may be calculated using the following formula:
Infusion rate (mL/min) = Dosage (ng/kg/min) × bodyweight (kg)
Concentration of solution (ng/mL)
Infusion rate (mL/h) = Infusion rate (mL/min) × 60
Pulmonary Arterial Hypertension
There are 4 packs available for use in the treatment of pulmonary arterial hypertension, as follows:

One vial containing sterile, freeze-dried Veletri equivalent to 0.5 mg Veletri, supplied with one
100 mL bottle of solvent.

One vial containing sterile, freeze-dried Veletri equivalent to 1.5 mg Veletri, supplied with one
100 mL bottle of solvent.

One vial containing sterile, freeze-dried Veletri equivalent to 0.5 mg Veletri supplied alone.

One vial containing sterile, freeze-dried Veletri equivalent to 1.5 mg Veletri supplied alone.
Initially a pack containing solvent for parenteral use must be used. During chronic Veletri therapy the final
concentration of solution may be increased by the addition of a further 0.5 mg or 1.5 mg vial of freeze-dried
Veletri.
Reconstitution:
Withdraw 5 mL of diluent into a sterile syringe, inject the contents of the syringe into the vial containing
Veletri and shake gently until the powder has dissolved. The reconstituted solution should be examined prior
to further dilution. Its use is forbidden in the presence of discolouration or particles. Any unused
reconstituted solution should be disposed of in accordance with local requirements.
Dilution:
The reconstituted solution should be immediately further diluted to the final concentration. Further dilution
should be performed with the same diluent as used for reconstitution of the sterile, lyophilised powder.
Veletri when administered chronically, should be prepared in a drug delivery reservoir appropriate for the
infusion pump.
Suitable ambulatory pumps to be used for the administration of VELETRI include:



CADD-Legacy 1
CADD-Legacy PLUS

Manufactured by Smiths Medical.
Pump accessories found to be compatible with the administration of VELETRI include:



CADD disposable Medication Cassette Reservoir 50 mL; 100 mL from Smiths Medical.
CADD extension set with in-line 0.2 micron filter (CADD extension set with male luer, 0.2- micron
air-eliminating filter, clamp, and integral anti-siphon valve with male luer) from Smiths Medical.

Only extension sets with an in-line 0.22 micron filter placed between the infusion pump and the catheter
must be used. It is recommended to use filters with a hydrophilic polyethersulfone membrane. The extension
set and the in-line filter must be changed at least every 48 hours.
The vial containing 0.5 mg epoprostenol must be used for the preparation of solutions with final
concentrations below 15,000 ng/mL.
Table 1 provides examples for preparing frequently used concentrations of Veletri solutions. Each vial is for
single use only.
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Table 1: Frequently used concentrations – Examples of Reconstitution and Dilution
Final Concentration (ng/mL)
3000 ng/mL
5000 ng/mL
10,000 ng/mL

15,000 ng/mL*
30,000 ng/mL*

30,000 ng/mL*

Directions:
Dissolve contents of one 0.5 mg vial with 5 mL of solvent
Withdraw 3 mL of the vial contents and add to a sufficient
volume of the identical diluent to make a total of 100 mL.
Dissolve contents of one 0.5 mg vial with 5 mL of solvent
Withdraw entire vial contents and add to a sufficient volume
of the identical diluent to make a total of 100 mL.
Dissolve contents of two 0.5 mg vials, each with 5 mL of
solvent
Withdraw entire vial contents and add to a sufficient volume
of the identical diluent to make a total of 100 mL.
Dissolve contents of one 1.5 mg vial with 5 mL of solvent
Withdraw entire vial contents and add to a sufficient volume
of the identical diluent to make a total of 100 mL.
Dissolve contents of two 1.5 mg vials, each with 5 mL of
solvent
Withdraw entire vial contents and add to a sufficient volume
of the identical diluent to make a total of 100 mL.
Dissolve contents of one 1.5 mg vial with 5 mL of solvent
Withdraw entire vial contents and add to a sufficient volume
of the identical diluent to make a total of 50 mL.

* Solutions with higher final concentrations may be necessary for patients who receive long-term administration of
Veletri.

Veletri diluted to the final concentration in the drug delivery reservoir as directed can be administered
immediately at room temperature (25°C) or, if stored, for up to 8 days at 2 to 8°C as per the conditions of use
outlined in Table 2.
Table 2: Maximum duration of administration (hours) at room temperature (25°C) of fully diluted solutions
stored in the drug delivery reservoir
Final concentration range

Immediate
administration*

≧ 3000 ng/mL and < 15,000 ng/mL
≧ 15,000 ng/mL

48 hours
48 hours

If stored for up to
8 days at 2° to
8°C*
24 hours
48 hours

Do not expose the fully diluted solution to direct sunlight.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Do not freeze.
The reconstituted solution should be immediately further diluted to the final concentration.
Reconstitution and dilution should be carried out immediately prior to use.
Freshly prepared epoprostenol diluted solutions for the treatment of pulmonary arterial hypertension can be
administered immediately at 25°C, or stored in the drug delivery reservoir in order to protect from light for
up to 8 days at between 2 to 8°C as per the conditions of use outlined in Table 2.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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