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EPIRUBICIN HYDROCHLORIDE 2 MG/ML SOLUTION FOR INJECTION/INTRAVESICAL USE

Active substance(s): EPIRUBICIN HYDROCHLORIDE / EPIRUBICIN HYDROCHLORIDE / EPIRUBICIN HYDROCHLORIDE

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Patient leaflet: Information for the user
Epirubicin Hydrochloride 2 mg/ml Solution for Injection/Intravesical Use
(Epirubicin Hydrochloride)

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, please ask your doctor, 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, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Epirubicin Hydrochloride 2 mg/ml Solution for Injection/Intravesical Use is and what it is
used for
2.
What you need to know before you use Epirubicin Hydrochloride Solution for
Injection/Intravesical Use
3.
How to use Epirubicin Hydrochloride Solution for Injection/Intravesical Use
4.
Possible side effects
5.
How to store Epirubicin Hydrochloride Solution for Injection/Intravesical Use
6.
Contents of the pack and other information
1.

What Epirubicin Hydrochloride 2 mg/ml Solution for Injection/Intravesical Use is
and what it is used for?

Epirubicin Hydrochloride Solution for Injection/Intravesical Use is an anti-cancer medicine. Treatment
with an anti-cancer medicine is sometimes called cancer chemotherapy.
Epirubicin hydrochloride is used to treat a variety of cancers, either alone or in combination with other
medicines. The way in which it is used depends upon the type of cancer that is being treated. It is useful in
treating the following conditions:



Cancer of the breast
Cancer of the stomach

Epirubicin hydrochloride Solution for injection/intravesical use is also used to help prevent recurrence of
bladder cancer after surgery.
You must talk to a doctor if you do not feel better or if you feel worse.
2.

What you need to know before you use Epirubicin Hydrochloride Solution for
Injection/Intravesical Use

Do not use Epirubicin hydrochloride injection:
 if you are allergic (hypersensitive) to epirubicin, similar medicines (called anthracyclines – see below)
or any of the other ingredients of epirubicin hydrochloride solution for injection/intravesical use (listed
in section 6)
 if you have fewer blood cells than normal. Your doctor will check this
 if you have been treated with high doses of some other anti-cancer medicines including doxorubicin
and daunorubicin which belong to the same group of medicines as epirubicin hydrochloride solution
for injection/intravesical use (called anthracyclines). They have similar side effects (including those
effects on the heart).
 if you have suffered or currently have problems with your heart





if you have severe liver problems
if you have a severe infection
if you are breast-feeding

When administered intravesically (directly into the bladder), epirubicin hydrochloride solution for
injection/intravesical use should not be used:
 if your tumour penetrates the bladder wall
 if you have a urine infection
 if you have pain or inflammation in your bladder
 if your doctor has problems inserting a catheter (tube) into your bladder
 if there is a large volume of urine left in your bladder after you attempt to empty it
 if there is blood in your urine
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Epirubicin hydrochloride
 to make sure the number of cells in your blood does not drop too low. Your doctor will check this
regularly.
 to check the level of uric acid in your blood. Your doctor will check this.
 to check the presence of blood in your urine. Your doctor will check this.
 if you have liver disease
 if you have kidney disease
 to make sure your heart is working properly. Your doctor will check this regularly.
 if you have received or are receiving radiotherapy to the chest area.
 if you are experiencing severe inflammation or ulcers in your mouth
 if you are planning to start a family, whether you are male or female
 if you experience extravasation of epirubicin (leakage of the solution out of the vein), which may cause
local pain, lesions and necrosis (death of living tissue) of surrounding tissue. If this occurs, the
injection should be immediately stopped.
Other medicines and Epirubicin hydrochloride:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
even those obtained without a prescription, particularly the following:











medicines that may affect your heart for example; calcium channel blockers (e.g. verapamil,
nifedipine and diltiazem),
cancer treatments such as doxorubicin, mitomycin-C, dacarbazine, dactinomycin and possibly
cyclophosphamide and radiotherapy
medicines that may affect your liver e.g. barbiturates (medicines used in epilepsy or sleep disorders)
and rifampicin (a medicine used to treat TB)
trastuzumab; epirubicin should not be taken within 27 weeks of taking trastuzumab
cimetidine (a medicine used to reduce the acid in your stomach)
paclitaxel and docetaxel (medicines used in some cancers)
interferon alfa-2b (a medicine used in some cancers and lymphomas and for some forms of hepatitis)
quinine (medicine used for treatment of malaria and for leg cramps)
dexrazoxane (a medicine sometimes used with doxorubicin to reduce the risk of heart problems)
dexverapamil (a medicine used to treat some heart conditions).

If you need to have any vaccinations, you must inform your doctor that you are being treated with
epirubicin before receiving the vaccination as certain types of vaccines (live and live-attenuated) may have
serious side effects.
Pregnancy, breast-feeding and fertility
Pregnancy

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 taking this medicine.
Due to the risk of birth defects, women of childbearing potential should use appropriate contraception
methods during treatment with epirubicin.
Breast-feeding
You must not breast feed if you are taking epirubicin
Fertility
Male patients may wish to seek advice on sperm preservation before treatment starts
Both men and women should use effective contraception during treatment with epirubicin and for 6 months
after treatment with epirubicin has finished.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel and/or be sick after being given this medicine, therefore special care should be taken when
driving or using machines.
Epirubicin hydrochloride contains sodium
This medicinal product contains less than 1mmol sodium (23 mg) per dose, i.e. essentially sodium free.
3.

How to use Epirubicin Hydrochloride Solution for Injection/Intravesical Use

The dose of medicine given to you will depend on the type of cancer you have, your health, how well your
liver and kidneys are working and any other medicines you may be taking.
The duration is decided by taking into the account the condition you have.
By injection or infusion into a vein
The medicine will be given to you as an injection into a vein over 3-5 minutes. Or it may be diluted with
glucose (sugar solution) or sodium chloride (salt water) before it is given slowly, usually via a drip into a
vein over 30 minutes. If the drip comes loose or the solution is leaking from the vein, you must tell the
nurse or doctor immediately. You may be given another dose of this medicine in 3 weeks.
By being put into the bladder (intravesical administration)
The medicine may be given directly into the bladder using a catheter. If this method is used, you should not
drink any fluids for 12 hours before treatment so that your urine will not dilute the medicine too much. The
medicine solution should be kept in your bladder for 1 hour after being given. You will need to alter your
position occasionally to ensure that the medicine reaches all parts of your bladder.
When emptying your bladder after the medicine has been given, take care that your urine does not come
into contact with your skin. In case contact does happen, thoroughly wash the affected area with soap and
water but do not scrub.
While you are receiving epirubicin hydrochloride solution for injection/intravesical use your doctor will
take regular blood tests. This is to measure the effect the medicine is having. Your doctor will also do
regular tests on how your heart is working.

If the medicine has been added to a bag of fluid for injection, or to be given into the bladder, it should be
labelled with the strength of the medicine, volume and the time after which it should not be used.
If you use more Epirubicin Hydrochloride Solution for Injection/Intravesical Use than you should:
As this medicine will be given to you while you are in hospital it is unlikely that you will be given too little
or too much. However, tell your doctor or pharmacist if you have any concerns.
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, epirubicin can have side effects although not everybody gets them. . If you experience
any of the following side effects when epirubicin is given by infusion into a vein, please contact your
doctor or nurse immediately as these are all serious. You may need urgent medical attention or
hospitalisation.





if there is any redness, pain or swelling at the injection site. Redness may occur commonly.
if you have symptoms of heart problems/ heart failure such as chest pain, shortness of breath, swelling
of your ankles (oedema), abnormal heart rhythm (these effects may occur up to several weeks months
or years after finishing treatment with epirubicin). These side effects are rare.
if you have a severe allergic reaction, symptoms include faintness, skin rash, swelling of the face and
difficulty in breathing or wheeze. In some cases collapse may occur. This side effect is rare.
Reduction in blood platelets which increases risk of bruising or bleeding.

Other side effects that may occur:

Very common: (may affect more than 1 in 10 people):





Lack of white blood cells (this leads to frequent infections; symptoms include fever, severe chills, sore
throat and mouth ulcers)
Decreased numbers of red blood cells leading to symptoms such as: tiredness, headaches, being short
of breath when exercising, looking pale, dizziness
Hair loss (alopecia) – may be quite severe. Beard growth may stop in men. Hair normally re-grows
when your treatment course ends
Red coloration of urine for 1-2 days after administration of treatment

Common: (may affect up to 1 in 10 people):










Infection
Loss of appetite (anorexia)
Dehydration
Hot flushes
Sore, red mouth with ulcers
Inflammation of the food pipe
Feeling and being sick (nausea and vomiting)
Diarrhoea
Injection site reactions (eg redness)

Uncommon: (may affect up to 1 in 100 people):


Inflammation of the veins (phlebitis) which may be associated with blood clots (thrombophlebitis) –
this may present as pain and/or swelling in your arms or legs

Rare: (may affect up to 1 in 1,000 people):



Dizziness
General feeling of being ill











Weakness,
Abnormal liver function test which are detected on blood tests
Heart disorders: abnormal ECG (electrical recording of the heart), changes in the rhythm or rate of the
heart (fast, slow or irregular), heart muscle disease
A skin rash commonly known as hives (urticaria)
Lack of periods (amenorrhoea)
Reduced levels of sperm in males (azoospermia)
Feeling unusually hot or cold (fever or chills)
Leukaemia (acute lymphocytic or acute myelogenous) may occur up to 3 years after treatment
Raised blood uric acid levels – which may be part of a syndrome associated with tumour breakdown.
Your doctor will monitor you with blood tests

Not known: (frequency cannot be estimated from the available data)
• Pneumonia
• Internal bleeding and lack of oxygen to tissues due to bone marrow suppression.
• Inflammation to the eye (conjunctivitis and keratitis)
• Discolouration of skin and nails
• Sensitive to light
• Rash, itch, skin changes
• Redness of the skin (erythema)
• Sensitive to skin treated with radiation
Side effects after epirubicin injection into the bladder
If this medicine is injected directly into the bladder (intravesically), only a small amount is absorbed into
the body so the side effects listed above are rare. However, inflammation and infection of the bladder may
occur and you may experience discomfort, pain or difficulty when passing urine and blood may be seen in
your urine. These side effects are mostly reversible. If you notice these side effects you should inform your
doctor.
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 national reporting system.
By reporting side effects you can help provide more information on the safety of this medicine

5.

How to store Epirubicin Hydrochloride Solution for Injection/Intravesical Use

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2ºC – 8ºC).
Keep the vial in the outer carton in order to protect from light.
Epirubicin hydrochloride, when diluted in either glucose 5% or sodium chloride 0.9%, should not normally
be stored for longer than 24 hours in a fridge.
Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled
product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4
hours equilibration at controlled room temperature (15–25ºC).
Do not use after the expiry date printed on the vial label and carton.

6.

Contents of the pack and other Information

What epirubicin hydrochloride solution for injection/intravesical use contains
The active substance is epirubicin hydrochloride. Each millilitre contains 2 milligrams of epirubicin
hydrochloride.
The other ingredients are sodium chloride, water for injections and hydrochloric acid used as a pH adjuster.
What epirubicin hydrochloride solution for injection/intravesical use looks like and contents of the pack
Epirubicin Hydrochloride 2 mg/ml injection is a clear red solution for injection or intravesical use.
Each millilitre (ml) of solution contains 2 milligrams (mg) of epirubicin hydrochloride. The medicine
comes in glass containers called vials with rubber closures, containing 10 mg (5 ml), 50 mg (25 ml), 100
mg (50 ml) and 200 mg (100 ml) of epirubicin hydrochloride.
The vials may be wrapped in a protective plastic to reduce the risk of spillage if the vials break; these are
referred to as ONCO-TAIN®.
The vials are available in single or 5 vial packs of 5 ml, 25 ml, 50 ml or 100 ml. Not all pack sizes may be
marketed.
Marketing authorisation holder and manufacturer: Hospira UK Limited, Queensway, Royal Leamington
Spa, Warwickshire, CV31 3RW, United Kingdom.

This leaflet was last revised in 10/2016

----------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
IMPORTANT: Refer to Summary of Product Characteristics before prescribing
For Intravenous Injection and Intravesical Administration
Incompatibilities
Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of
the drug, which includes sodium bicarbonate containing solutions. Only the diluents detailed in ‘Dilution
Instructions’ should be used.
Neither the injection nor any diluted solution should be mixed with any other drugs. (A physical
incompatibility with heparin has been reported).
Dilution Instructions
The injection may be given via the tubing of a free-running intravenous saline infusion. Where the injection
is to be administered after dilution, the following instructions should be followed.
Epirubicin Hydrochloride solution for injection/intravesical use may be diluted under aseptic conditions in
glucose 5% or sodium chloride 0.9% and administered as an intravenous infusion. The infusion solution
should be prepared immediately before use.
The injection solution contains no preservative and any unused portion of the vial should be discarded
immediately.

Safe Handling
This is a cytotoxic product, please follow your local policy guidelines for instructions on the safe
handling/disposal of cytotoxics.
Storage
Store at 2-8ºC.
Keep container in the outer carton.
In use: Epirubicin Hydrochloride 2 mg/ml solution for injection/intravesical use may be further diluted as
detailed above. The infusion solution is chemically stable when stored in PVC infusion bags prepared
under full aseptically controlled conditions for 14 days at 25ºC ± 2ºC or for 28 days at 2-8ºC in the absence
of light. From a microbiological point of view however, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8ºC.
Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled
product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4
hours equilibration at controlled room temperature (15–25ºC).
Marketing Authorisation Holder
Hospira UK Limited
Warwickshire, CV31 3RW
UK
This leaflet was last revised in 10/2016

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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