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VELETRI 0.5 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): EPOPROSTENOL / EPOPROSTENOL / EPOPROSTENOL

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900
Veletri for inj. - UK/IE
SM 0046 IP

Actelion Pharmaceuticals

Istruzione/Leaflet

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Codice datamatrix

400 x 700 mm
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Actelion
Pharmaceuticals Ltd

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21.06.2017 kh 8

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Veletri for inj. - UK/IE

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251551

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UK/IE

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Order file
Typopharma GmbH
Mühlestr. 57
Country
D-79539 Lörrach
produktion@typopharma.com Format/dimensions
www.typopharma.com
typopharma no:
# 126999

Patheon Italy

Contr. manufact. no. N/A

400 x 700 mm

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251551

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4. Possible side effects

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Package leaflet: Information for the user

The following information is intended for medical or healthcare professionals only:

®

Veletri 0.5 mg, Powder for Solution for Infusion
Veletri® 1.5 mg, Powder for Solution for Infusion
Epoprostenol

Pulmonary Arterial Hypertension

Common side effects that may show up in blood tests
▯ decrease in the number of blood platelets (cells that help the blood to clot)

There are 2 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 alone.
▯ One vial containing sterile, freeze-dried Veletri equivalent to 1.5 mg Veletri
supplied alone.

Rare side effects
These may affect up to 1 in 1000 people:
▯ infection at the injection site

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.

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.

Dissolve contents of one 0.5 mg vial with 5 mL
of either Sterile Water for Injection or Sodium
Chloride 0.9% Injection.
Withdraw 3 mL of the vial contents and add to a
sufficient volume of the identical diluent to make
a total of 100 mL.

5000 ng/mL

Dissolve contents of one 0.5 mg vial with 5 mL
of either Sterile Water for Injection, or Sodium
Chloride 0.9% Injection.
Withdraw entire vial contents and add to a
sufficient volume of the identical diluent to make
a total of 100 mL.

10,000 ng/mL

Dissolve contents of two 0.5 mg vials, each
with 5 mL of either Sterile Water for Injection or
Sodium Chloride 0.9% Injection.
Withdraw entire vial contents and add to a
sufficient volume of the identical diluent to make
a total of 100 mL.

15,000 ng/mL*

Dissolve contents of one 1.5 mg vial with 5 mL
of either Sterile Water for Injection or Sodium
Chloride 0.9% Injection.
Withdraw entire vial contents and add to a
sufficient volume of the identical diluent to make
a total of 100 mL.

30,000 ng/mL*

Dissolve contents of two 1.5 mg vials, each
with 5 mL of either Sterile Water for Injection or
Sodium Chloride 0.9% Injection.
Withdraw entire vial contents and add to a
sufficient volume of the identical diluent to make
a total of 100 mL.

30,000 ng/mL*

Dissolve contents of one 1.5 mg vial with 5 mL
of either Sterile Water for Injection or Sodium
Chloride 0.9% Injection.
Withdraw entire vial contents and add to a
sufficient volume of the identical diluent to make
a total of 50 mL.

The other ingredients are Sucrose, Arginine and Sodium Hydroxide (for pH
adjustment).

Immediate
administration*

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

Marketing Authorisation Holder:
Actelion Registration Ltd
Chiswick Tower 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

⭌ 3000 ng/mL and < 15,000 ng/mL

48 hours

24 hours

⭌ 15,000 ng/mL

48 hours

48 hours

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Do not expose the fully diluted solution to direct sunlight.

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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.

Final concentration range

Marketing Authorisation Holder and Manufacturer

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Kidney dialysis
You will be given an infusion of Veletri for the duration of your dialysis.

Table 2: Maximum duration of administration (hours) at room temperature (25°C) of
fully diluted solutions stored in the drug delivery reservoir

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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.

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.

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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.

What Veletri looks like and contents of the pack

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.

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Veletri is given by slow infusion (drip) into a vein.



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

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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.

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Veletri should not be given as a quick injection into your vein. It should always be
given as an intravenous infusion.

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Veletri comes as a powder in a small glass vial. The powder needs to be dissolved
before use.

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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 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).

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3. How to take Veletri

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Don’t drive or use machines unless you’re feeling well.

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What Veletri contains

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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.

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Do not use this medicine if you notice any particles in the reconstituted solution.

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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.

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This medicinal product (powder for solution for infusion) does not require any
special temperature storage conditions. Do not freeze.

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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 after
EXP. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

Your treatment may have an effect on the ability to drive or use machinery.

3000 ng/mL

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Driving and using machines

Directions:

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It is not known whether the ingredients of Veletri can pass into breast-milk. You
should stop breastfeeding your child during treatment with Veletri.

5. How to store Veletri

Final Concentration
(ng/mL)

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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.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

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Pregnancy and breastfeeding

Table 1: Frequently used concentrations – Examples of Reconstitution and Dilution

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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.

Table 1 provides examples for preparing frequently used concentrations of Veletri
solutions. Each vial is for single use only.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.

The vial containing 0.5 mg epoprostenol must be used for the preparation of
solutions with final concentrations below 15,000 ng/mL.

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Other medicines and Veletri

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The safety and efficacy of VELETRI in children have not yet been established.

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Children and adolescents

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Tell your doctor if you get these symptoms. Your dose may need to be reduced or
your infusion stopped.

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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.

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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.

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.

Effect of Veletri on blood pressure and heart rate

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Manufactured by Smiths Medical.

If you get the following side effects, talk to 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.

Contact the hospital immediately for advice if the area becomes sore, painful or
swollen or you notice any blistering or shedding.

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Suitable ambulatory pumps to be used for the administration of VELETRI include:
▯ CADD-Legacy 1
▯ CADD-Legacy PLUS

Reporting of side effects

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.

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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.

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Skin damage at the injection site

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Before you are given Veletri your doctor needs to know:
▯ if you have any problems with bleeding.

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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

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Reconstitution:
Withdraw 5 mL of either Sterile Water for Injection or Sodium Chloride 0.9%
Injection 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.

Other side effects
It is not known how many people are affected by:
▯ enlarged or overactive spleen
▯ build up of fluid in the lungs (pulmonary oedema)
▯ increase in sugar (glucose) in the blood
▯ ascites (build-up of fluid in the belly)

Veletri contains sodium (less than 1 mmol sodium (23 mg) per dose)

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Uncommon side effects
These may affect up to 1 in 100 people:
▯ sweating
▯ dry mouth

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Talk to your doctor before using Veletri.

Infusion rate (mL/h) = Infusion rate (mL/min) × 60

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Warnings and precautions

Infusion rate (mL/min) = Dosage (ng/kg/min) × bodyweight (kg)
Concentration of solution (ng/mL)

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If you think any of these apply to you, don’t take Veletri until you have checked
with your doctor.

Calculation of infusion rate:
Infusion rates may be calculated using the following formula:

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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.

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2. What you need to know before you use Veletri

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.

14

Veletri is used to prevent blood clotting during kidney dialysis when heparin cannot
be used.

13

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.

12

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.

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

Reconstitution:
Withdraw 5 mL of either Sterile Water for Injection or Sodium Chloride 0.9%
Injection 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.

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1. What Veletri is and what it is used for

Renal Dialysis
There is 1 pack available for use in the treatment of renal dialysis:
▯ One vial containing sterile, freeze-dried Veletri equivalent to 0.5 mg Veletri
supplied alone.

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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

INFORMATION FOR HEALTHCARE PROFESSIONALS

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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.

7.

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)

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Like all medicines, this medicine can cause side effects, although not everybody
gets them.

Special precautions for storage

This medicinal product is authorised in the Member States of the EEA under
the following names:

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Veletri
Caripul®

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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.

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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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.

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Manufacturer:
Actelion Manufacturing GmbH
Emil-Barell-Strasse 7
79639 Grenzach-Wyhlen
Germany

This leaflet was last revised in 12/05/2017

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If you take more Veletri than you should

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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).

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If you forget to take Veletri
Do not take a double dose to make up for a forgotten dose.

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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.

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Expand Transcript

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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