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EPREX 40 000 IU PER ML SOLUTION FOR INJECTION IN PFS

Active substance(s): EPOETIN ALFA

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EPREX®

2,000 IU/ml, 4,000 IU/ml,
10,000 IU/ml AND 40,000 IU/ml
SOLUTION FOR INJECTION in
PRE-FILLED SYRINGES
(epoetin alfa)
Read all of this leaŲet carefully before you start using
this medicine because it contains important information
for you.

• Keep this leaŲet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
• If you get any side eŮects, talk to your doctor, nurse, or pharmacist.
This includes any possible side eŮects not listed in this leaŲet.
See section 4, Possible side eŮects.

What is in this leaŲet:
1 What EPREX is and what it is used for
2 What you need to know before you use EPREX
3 How to use EPREX
4 Possible side eŮects
5 How to store EPREX
6 Contents of the pack and other information

1 What EPREX is and what it is used for
EPREX contains the active substance epoetin alfa - a protein that
stimulates the bone marrow to produce more red blood cells which carry
haemoglobin (a substance that transports oxygen). Epoetin alfa is a copy
of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the
same way.
• EPREX is used to treat symptomatic anaemia caused by kidney
disease
• in children on haemodialysis
• in adults on haemodialysis or peritoneal dialysis
• in severely anaemic adults not yet undergoing dialysis.
If you have kidney disease, you may be short of red blood cells if your
kidney does not produce enough erythropoietin (necessary for red cell
production). EPREX is prescribed to stimulate your bone marrow to
produce more red blood cells.
• EPREX is used to treat anaemia in adults receiving
chemotherapy for solid tumours, malignant lymphoma or multiple
myeloma (bone marrow cancer) who may have a need for a blood
transfusion. EPREX can reduce the need for a blood transfusion in
these patients.
• EPREX is used in moderately anaemic adults who donate some
of their blood before surgery, so that it can be given back to them
during or after the operation. Because EPREX stimulates the production
of red blood cells, doctors can take more blood from these people.
• EPREX is used in moderately anaemic adults about to have major
orthopaedic surgery (for example hip or knee replacement
operations), to reduce the potential need for blood transfusions.

EPREX®

EPREX®

Package leaŲet: Information for the user

2 What you need to know before you use
EPREX
Do not use EPREX

• If you are allergic (hypersensitive) to epoetin alfa or any of the other
ingredients of EPREX (listed in section 6, Contents of the pack and
other information).
• If you have been diagnosed with Pure Red Cell Aplasia (the bone
marrow cannot produce enough red blood cells) after previous
treatment with any product that stimulates red blood cell production
(including EPREX). See section 4, Possible side eŮects.
• If you have high blood pressure not properly controlled with
medicines.
• To stimulate the production of your red blood cells (so that doctors can
take more blood from you) if you cannot have transfusions with
your own blood during or after surgery.
• If you are due to have major elective orthopaedic surgery (such as
hip or knee surgery), and you:
• have severe heart disease
• have severe disorders of the veins and arteries
• have recently had a heart attack or stroke
• can’t take medicines to thin the blood
EPREX may not be suitable for you. Please discuss with your doctor.
While on EPREX, some people need medicines to reduce the risk of
blood clots. If you can’t take medicines that prevent blood clotting,
you must not have EPREX.

Warnings and precautions
Take special care with EPREX

EPREX and other products that stimulate red cell production may
increase the risk of developing blood clots in all patients. This risk
may be higher if you have other risk factors for developing blood
clots (for example, if you have had a blood clot in the past or are
overweight, have diabetes, have heart disease or you are oŮ your feet for
a long time because of surgery or illness). Please tell your doctor about
any of these things. Your doctor will help you to decide if EPREX is
suitable for you.
It is important to tell your doctor if any of the following apply to you.
You may still be able to use EPREX, but discuss it with your doctor Űrst.
• If you know you suŮer, or have suŮered, from:
• high blood pressure;
• epileptic seizures or Űts
• liver disease
• anaemia from other causes
• porphyria (a rare blood disorder)
• If you are a patient with chronic renal failure, and particularly if you
do not respond properly to EPREX, your doctor will check your dose of
EPREX because repeatedly increasing your dose of EPREX if you are
not responding to treatment may increase the risk of having a problem
of the heart or the blood vessels and could increase risk of myocardial
infarction, stroke and death.
• If you are a cancer patient be aware that products that stimulate red
blood cell production (like EPREX) may act as a growth factor and
therefore in theory may aŮect the progression of your cancer.
Depending on your individual situation a blood transfusion may
be preferable. Please discuss this with your doctor.
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Other medicines and EPREX

EPREX does not normally react with other medicines but please tell your
doctor if you are using (or have recently used) any other medicines –
including medicines obtained without a prescription.
If you are taking a drug called cyclosporin (used e.g. after kidney
transplants), your doctor may order blood tests to check the level of
cyclosporin while you are taking EPREX.
Iron supplements and other blood stimulants may increase the
eŮectiveness of EPREX. Your doctor will decide if it is right for you to take them.
If you visit a hospital, clinic or family doctor, tell them you are having
EPREX treatment. It may aŮect other treatments or test results.

Pregnancy and breast-feeding

It is important to tell your doctor if any of the following apply to you.
You may still be able to use EPREX, but discuss it with your doctor Űrst.
• If you are pregnant, or think you may be pregnant.
• If you are breast feeding.

3 How to use EPREX
Always use this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
Your doctor has carried out blood tests and decided you need EPREX.
EPREX may be given by injection:
• Either into a vein or a tube that goes into a vein (intravenously)
• Or under the skin (subcutaneously).
Your doctor will decide how EPREX will be injected. Usually the injections
will be given to you by a doctor, nurse or other health care professional.
Some people, depending on why they need EPREX treatment, may later
learn how to inject themselves under the skin: see Instructions on how to
inject EPREX yourself.
EPREX should not be used:
• after the expiry date on the label and outer carton
• if you know, or think that it may have been accidentally frozen, or
• if there has been a refrigerator failure.
The dose of EPREX you receive is based on your bodyweight in
kilograms. The cause of your anaemia is also a factor in your doctor
deciding the correct dose.
Your doctor will monitor your blood pressure regularly while you are
using EPREX.

People with kidney disease

• Your doctor will maintain your haemoglobin level between 10 and 12 g/dl
as a high haemoglobin level may increase the risk of blood clots and
death.
• The usual starting dose of EPREX for adults and children is
50 International Units (IU) per kilogram (/kg) of bodyweight given three
times a week.
• For patients on peritoneal dialysis EPREX may be given twice a week.
• For adults and children EPREX is given as an injection either into a vein
or a tube that goes into a vein. When this access (via a vein or tube) is
not readily available, your doctor may decide that EPREX should be
injected under the skin (subcutaneously). This includes patients on
dialysis and patients not yet on dialysis.
• Your doctor will order regular blood tests to see how your anaemia is
responding and may adjust the dose, usually no more frequently than
every four weeks.
• Once your anaemia has been corrected, your doctor will continue
to check your blood regularly. Your EPREX dose and frequency of
administration may be further adjusted to maintain your response
to treatment. Your doctor will use the lowest eŮective dose to control the
symptoms of your anemia.
• If you do not respond adequately to EPREX, your doctor will check your
dose and will inform you if you need to change doses of EPREX.
• If you are on a more extended dosing interval (greater than once weekly)
of EPREX, you may not maintain adequate haemoglobin levels and you
may require an increase in EPREX dose or frequency of administration.
• You may be given iron supplements before and during EPREX treatment
to make it more eŮective.
• If you are having dialysis treatment when you begin treatment with
EPREX, your dialysis regime may need to be adjusted. Your doctor will
decide this.

Adults on chemotherapy

• Your doctor may initiate treatment with EPREX if your haemoglobin is
10 g/dl or less.
• Your doctor will maintain your haemoglobin level between 10 and 12 g/dl
as a high haemoglobin level may increase the risk of blood clots and
death.
• The starting dose is either 150 IU per kilogram bodyweight three times
a week or 450 IU per kilogram bodyweight once a week.
• EPREX is given by injection under the skin.
• Your doctor will order blood tests, and may adjust the dose, depending
on how your anaemia responds to EPREX treatment.
• You may be given iron supplements before and during EPREX treatment
to make it more eŮective.
• You will usually continue EPREX treatment for one month after the end
of chemotherapy.

Adults donating their own blood

• The usual dose is 600 IU per kilogram bodyweight twice a week.
• EPREX is given by injection into a vein immediately after you have
donated blood for 3 weeks before your surgery.
• You may be given iron supplements before and during EPREX treatment
to make it more eŮective.

Adults scheduled for major orthopaedic surgery

• The recommended dose is 600 IU per kilogram bodyweight once
a week.
• EPREX is given by injection under the skin each week for three weeks
before surgery and on the day of surgery.
• If there is a medical need to reduce the time before your operation,
you will be given a daily dose of 300 IU/kg for up to ten days before
surgery, on the day of surgery and for four days immediately afterwards.
• If blood tests show your haemoglobin is too high before the operation,
the treatment will be stopped.
• You may be given iron supplements before and during EPREX treatment
to make it more eŮective.

Instructions on how to inject EPREX
yourself
When treatment starts, EPREX is usually injected by medical or nursing
staŮ. Later, your doctor may suggest that you or your caregiver learn how
to inject EPREX under the skin (subcutaneously) yourself.
• Do not attempt to inject yourself unless you have been trained to
do so by your doctor or nurse.
• Always use EPREX exactly as instructed by your doctor or nurse.
• Only use EPREX if it has been stored correctly – see section 5,
How to Store EPREX.
• Before use, leave the EPREX syringe to stand until it reaches
room temperature. This usually takes between 15 and 30 minutes.
Only take one dose of EPREX from each syringe.
If EPREX is injected under the skin (subcutaneously), the amount injected
is not normally more than one millilitre (1 ml) in a single injection.
EPREX is given alone and not mixed with other liquids for injection.
Do not shake EPREX syringes. Prolonged vigorous shaking may damage
the product. If the product has been shaken vigorously, don’t use it.

Instructions on how to inject EPREX
yourself (continued)
How to inject yourself using a pre-Űlled syringe:

The pre-Űlled syringes are Űtted with the PROTECS™ needle guard
device to help prevent needle stick injuries after use. This is indicated on
the packaging.
Figure 1 shows what the pre-Űlled syringe looks like.

If you are a patient with hepatitis C and you receive
interferon and ribavirin

You should discuss this with your doctor because a combination of
epoetin alfa with interferon and ribavirin has led to a loss of eŮect and
development of a condition called pure red cell aplasia (PRCA), a severe
form of anemia, in rare cases. EPREX is not approved in the management
of anaemia associated with hepatitis C.
If you have any further questions on the use of this product, ask your
doctor, nurse or pharmacist.

4 Possible side eŮects

Figure 1
• Take a syringe out of the refrigerator. The liquid needs to come
to room temperature. Do not remove the syringe’s needle cover while
allowing it to reach room temperature.
• Check the syringe, to make sure it is the right dose, has not passed
its expiry date, is not damaged, and the liquid is clear and not frozen.
• Choose an injection site. Good sites are the top of the thigh and
around the tummy (abdomen) but away from the navel. Vary the site
from day to day.
• Wash your hands. Use an antiseptic swab on the injection site,
to disinfect it.
• Hold the pre-Űlled syringe by the body of the syringe with the
covered needle pointing upward.
• Do not hold by the plunger head, plunger, needle guard wings,
or needle cover.
• Do not pull back on the plunger at any time.
• Do not remove the needle cover from the pre-Űlled syringe until
you are ready to inject your EPREX®.
• Take the cover oŮ the syringe by holding the barrel and pulling the
cover oŮ carefully without twisting it. Don’t push the plunger, touch the
needle or shake the syringe.
• Do not touch the needle activation clips (as indicated by
asterisks* in Figure 1) to prevent prematurely covering the needle
with the needle guard
• Pinch a fold of skin between your thumb and index Űnger.
Don’t squeeze it.
• Push the needle in fully. Your doctor or nurse may have shown you
how to do this.
• Push the plunger with your thumb as far as it will go to inject the
entire amount of liquid. Push it slowly and evenly, keeping the skin
fold pinched. The PROTECS™ needle guard will not activate unless
the entire dose is given. You may hear a click when the
PROTECS™ needle guard has been activated.
• When the plunger is pushed as far as it will go, take out the needle
and let go of the skin.
• Slowly take your thumb oŮ the plunger to allow the syringe to move
up until the entire needle is covered by the PROTECS™ needle guard.
• When the needle is pulled out of your skin, there may be a little
bleeding at the injection site. This is normal. You can press an
antiseptic swab over the injection site for a few seconds after the
injection.
• Dispose of your used syringe in a safe container – see section 5,
How to store EPREX.

If you use more EPREX than you should

Tell the doctor or nurse immediately if you think too much EPREX has
been injected. Side eŮects from an overdose of EPREX are unlikely.

If you forget to use EPREX

Make the next injection as soon as you remember. If you are within a day
of your next injection, forget the missed one and carry on with your
normal schedule. Do not double up the injections.

Like all medicines, EPREX can cause side eŮects, although not
everybody gets them.
Tell your doctor or nurse immediately if you notice any of the eŮects
in this list.
Very common side eŮects
These may aŮect more than 1 person in 10 using EPREX.
• Diarrhoea
• Feeling sick in your stomach
• Vomiting
• Fever
• Respiratory tract congestion, such as stuŮy nose and sore throat,
has been reported in patients with kidney disease not yet on dialysis.
Common side eŮects
These may aŮect up to 1 in 10 people using EPREX.
• Increased blood pressure. Headaches, particularly sudden, stabbing
migraine-like headaches, feeling confused or having Űts may be
signs of a sudden increase in blood pressure. This requires urgent
treatment. Raised blood pressure may require treatment with drugs
(or adjustment to any drugs you already take for high blood pressure).
• Blood clots (including deep vein thrombosis and embolism) that may
require urgent treatment. You may have chest pain, breathlessness,
and painful swelling and redness, usually in the leg as symptoms.
• Cough
• Skin rashes, which may result from an allergic reaction.
• Bone or muscle pain
• Flu-like symptoms, such as headache, aches and pains in the joints,
feeling of weakness, chills, tiredness and dizziness. These may be more
common at the start of treatment. If you have these symptoms during
injection into the vein, a slower delivery of the injection may help to
avoid them in the future.
• Redness, burning and pain at the site of injection
• Swelling of the ankles, feet or Űngers
Uncommon side eŮects
These may aŮect up to 1 in 100 people using EPREX.
• High levels of blood potassium which can cause abnormal heart
rhythm (this is a very common side eŮect in patients on dialysis).
• Fits
• Nose or airway congestion
Very rare side eŮects
These may aŮect up to 1 in 10,000 people using EPREX.
• Symptoms of pure red cell aplasia (PRCA)
PRCA means the bone marrow does not make enough red blood cells.
PRCA causes sudden and severe anaemia. The symptoms are:
• unusual tiredness,
• feeling dizzy,
• breathlessness.
PRCA has been very rarely reported mostly in patients with kidney
disease after months to years of treatment with EPREX and other
products that stimulate red blood cell production.
• An increase in levels of small blood cells (called platelets), which are
normally involved in the formation of a blood clot may occur, particularly
when starting treatment. Your doctor will check on this.

If you are receiving haemodialysis:
• Blood clots (thrombosis) may form in your dialysis shunt. This is more
likely if you have low blood pressure or if your Űstula has complications.
• Blood clots may also form in your haemodialysis system. Your doctor
may decide to increase your heparin dose during dialysis.
Tell your doctor or nurse immediately if you are aware of any of these
eŮects, or if you notice any other eŮects while you are receiving treatment
with EPREX.

Reporting of side eŮects

If you get any side eŮects, talk to your doctor, nurse or pharmacist. This
includes any possible side eŮects not listed in this leaŲet.
In the UK, you can also report side eŮects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
In Ireland, you can also report side eŮects directly via: HPRA
Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: medsafety@hpra.ie
By reporting side eŮects you can help provide more information on the
safety of this medicine.

5 How to store EPREX
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 box
and on the label after the letters EXP. The expiry date refers to the last
day of that month.
Store in a refrigerator (2°C-8°C). You may take EPREX out of the
refrigerator and keep it at room temperature (up to 25°C) for no longer
than 3 days. Once a syringe has been removed from the refrigerator and
has reached room temperature (up to 25°C) it must either be used within
3 days or disposed of.
Do not freeze or shake.
Store in the original package in order to protect from light.
Do not use this medicine if you notice that the seal is broken or if the
liquid is coloured or you can see particles Ųoating in it. In the event of
either being observed, discard the medicinal product.
Do not throw away any medicines via waste water 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 EPREX contains:

The active substance is: Epoetin alfa (for quantity see the table below).
The other ingredients are: Polysorbate 80, sodium chloride, sodium
dihydrogen phosphate dihydrate, disodium phosphate dihydrate, glycine
and water for injections.
This medicinal product contains less than 1 mmol sodium (23 mg),
per dose i.e. essentially “sodium free.”

What EPREX looks like and contents of the pack

EPREX is presented as a solution for injection in pre-Űlled syringe.
The pre-Űlled syringes are Űtted with the PROTECS™ needle guard
device (see the table below). EPREX is a clear, colourless solution.
Corresponding
Presentations in
Quantity/Volume
for each Strength

Amount of
epoetin alfa

2,000 IU/ml:
1,000 IU/0.5 ml

8.4 micrograms

4,000 IU/ml:
2,000 IU/0.5 ml

16.8 micrograms

10,000 IU/ml:
3,000 IU/0.3 ml
4,000 IU/0.4 ml
5,000 IU/0.5 ml
6,000 IU/0.6 ml
8,000 IU/0.8 ml

25.2 micrograms
33.6 micrograms
42.0 micrograms
50.4 micrograms
67.2 micrograms

10,000 IU/1 ml

84.0 micrograms

Packs of 1 single pre-Űlled
syringe with PROTECS™
needle guard device

20,000 IU/0.5 ml
30,000 IU/0.75 ml
40,000 IU/1 ml

168 micrograms
252 micrograms
336 micrograms

Packs of 4 single pre-Űlled
syringes with PROTECS™
needle guard device

20,000 IU/0.5 ml
30,000 IU/0.75 ml
40,000 IU/1 ml

168 micrograms
252 micrograms
336 micrograms

Packs of 6 single pre-Űlled
syringes with PROTECS™
needle guard device

20,000 IU/0.5 ml
30,000 IU/0.75 ml
40,000 IU/1 ml

168 micrograms
252 micrograms
336 micrograms

Presentation
Packs of 6 single pre-Űlled
syringes with PROTECS™
needle guard device

Not all packs may be marketed.
Marketing Authorisation Holder
Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
Manufacturer:
Janssen Biologics B.V.
Einsteinweg 101
2333 CB
Leiden
The Netherlands
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria: ERYPO®
Belgium: EPREX®
Germany: ERYPO®
Denmark: EPREX®
Greece: EPREX®
Finland: EPREX®
France: EPREX®
Ireland: EPREX®
Italy: EPREX®
Luxemburg: EPREX®
Netherlands: EPREX®
Portugal: EPREX®
Spain: EPREX®
Sweden: EPREX®
UK: EPREX®
This leaŲet was revised in April
12/2015
2016

© J-C 2016

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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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