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EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION

Active substance(s): EPIRUBICIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Epirubicin 2 mg/ml
Solution For Injection
(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, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Epirubicin is and what it is used for
What you need to know before you use Epirubicin
How to use Epirubicin
Possible side effects
How to store Epirubicin
Contents of the pack and other information

1. What Epirubicin is and what it is used for
Epirubicin is an anti-cancer medicine. Treatment with an anti-cancer
medicine is sometimes called cancer chemotherapy.
Epirubicin is used in the treatment of:
• Breast and gastric cancers
• Bladder cancers
Epirubicin is also used to help prevent recurrence of bladder cancer
after surgery.

2. What you need to know before you use Epirubicin
Do not use Epirubicin:

• if you are allergic to epirubicin hydrochloride, to any of the other
ingredients of this medicine (listed in section 6) or to similar medicines,
• if you are breastfeeding,
• if your blood cell count is too low as epirubicin can lower your blood
count further. This is measured by health care personnel.
• if you have severe liver disease
• if you have suffered or currently have problems with your heart
• if you have a severe infection
• if you have been previously treated with epirubicin or similar medicines
as previous treatment with epirubicin or similar medicines can increase
the risk of side effects
When administered intravesically (directly into the bladder), epirubicin
should not be used if:
• the cancer has penetrated the bladder wall,
• you have an infection in your urine,
• you have pain or inflammation in your bladder,
• your doctor has problem inserting a catheter (tube) into your bladder,
• you have blood in your urine,
• there is a large volume of urine left in your bladder after you attempt to
empty it.
• if your bladder is contracted

Warnings and precautions
Talk to your doctor before using Epirubicin

• to ensure the number of cells in your blood does not drop too low and
you are not ill with a severe infection. Your doctor will regularly check this,
• if you are experiencing severe inflammation or ulcers in your mouth,
• to check the level of uric acid in your blood. Your doctor will regularly
check this,
• if you have liver or kidney disease. Epirubicin may not be suitable for you
or a reduced dose may have to be used.
• to ensure your heart is working properly. Your doctor will regularly check
this by doing regular heart function tests.
• if you have received or are receiving radiotherapy to the chest area,
• if you are planning to start a family, whether you are male or female,
• if you have received or are receiving trastuzumab (a medicine used to
treat certain cancers like breast cancer),
• if you have had or are due to have any vaccination,
• if you are elderly.
Extravasation (leakage of the solution out of the vein) of epirubicin 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

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Epirubicin should not be used:
• 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 drugs as epirubicin (called anthracyclines). They have
similar side effects (including their effects on the heart)
Special care will be taken if you are taking any of the following medicines:
• other medicines that may affect your heart and/or liver,
• cimetidine (a drug used to reduce the acidity in your stomach),
• paclitaxel and docetaxel (drugs used in some cancers),
• interferon alpha-2b ( a drug used in some cancers and lymphomas and
for some forms of hepatitis),
• quinine (a drug used for treatment of malaria and for leg cramps),
• dexrazoxane (a drug sometimes used with doxorubicin),
• dexverapamil (a drug used to treat some heart conditions),
• if you have received or are receiving trastuzumab (a medicine used to
treat certain cancers like breast cancer),
• other medicines that may affect your bone marrow or reduce the
numbers of cells in your blood.
The use of certain types of vaccines (live vaccines or live-attenuated
vaccines) should be avoided if you are receiving epirubicin treatment.
Killed or inactivated vaccines may be given; however the response may
be diminished.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before taking
this medicine.
If you become pregnant whilst receiving this medicine you should inform
your doctor immediately.
Both men and women should use effective contraception during treatment
with Epirubicin and for 6 months after treatment with epirubicin has finished.
Epirubicin can have an anti-fertility effect. Therefore, male patients
treated with epirubicin are advised not to father a child during and up to
6 months after treatment and to seek advice on conservation of sperm prior
to treatment.

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 contains sodium.
This medicinal product contains 3.6 mg sodium per ml. To be taken into
consideration by patients on a controlled sodium diet.

3. How to use Epirubicin
The dose of medicine given to you will depend on the type of cancer you
have, your health, how well your liver is working and any other medicines
you may be taking.
Method of administration, like the frequency of administration and duration
of treatment, will depend on the route of administration as detailed below:

By injection or infusion into a vein

The medicine may be given as an injection into a vein over 3-5 minutes.
It may also be diluted with glucose (sugar solution) or sodium chloride
(salt water) before it is infused slowly, usually via a drip into a vein over
30 minutes. You may be given another dose of this medicine in 3 weeks.

By injection into the bladder through a tube (‘catheter’)
(intravesical administration)

The medicine may be given directly into the bladder using a catheter. If this
route is used, you should not drink any fluids for 12 hours before treatment
so that your urine will not dilute the drug too much. The solution should
be kept in your bladder for 1-2 hours after instillation. You will be rotated
occasionally to ensure even exposure of all parts of the bladder to the drug.
Care should be taken to ensure that the contents of the bladder, when
emptied, do not come into contact with the skin. In case of skin contact,
thoroughly wash the affected area with soap and water but do not scrub.
While you are receiving this medicine your doctor will take regular blood
tests. This is to measure the effect the drug is having. Your doctor will also
do regular tests on how your heart is working.
If the injection has been added to a bag of fluid for injection, or for
administration to the bladder, it should be labelled with the strength of the
drug, volume and the time after which it should not be used.

The following information is intended for healthcare professionals only:
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) 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.

Description Epirubicin Hydrochloride 200 mg / 100 ml all
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 736255

SAP No. N/A

Superceded Affiliate Item Code 397775
TrackWise PR No. 736255
MA No. 04569/0983
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 265367
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 12 Jan 2016

Page Count 1/2

No. of colours 1
Colours

Time: 16:02

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 120 x 600mm

Min Text Size used 9 pt

Sign-offs

v1/May 2015

As this medicine will be given to you whilst 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.

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

If any of the following happen when epirubicin is given by infusion
into a vein, tell your doctor immediately:

• if there is any redness, pain or swelling at the injection site,
• if you have symptoms of heart problems such as chest pain, shortness
of breath, swelling of your ankles, abnormal heart rhythm (these effects
may occur several weeks, months or years after finishing treatment with
epirubicin),
• if you have a severe allergic reaction; symptoms include faintness, skin
rash, itching, swelling of the face, fever, chills and difficulty in breathing
or wheezing. In some cases collapse may occur.
These are very serious side effects. You may need urgent medical attention.
Other side effects may also be noticed after infusion of epirubicin into a vein.
Very common: may affect more than 1 in 10 peopleLack 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;
• Anorexia (loss of appetite), dehydration
• Hot flushes
• Sore, red mouth (may appear 5-10 days after starting treatment; also
mouth ulcers or cold sores with swollen/inflamed, painful and bleeding
areas in the mouth, along the side and under the tongue)
• Inflammation of the food pipe
• Feeling sick (nausea), being sick (vomiting)
• Diarrhoea
• Stomach pain
• Redness along the vein in which the product is administered, local
inflammation of a vein
Uncommon: may affect up to 1 in 100 people
• Low blood platelet count making you bleed or bruise more easily than
normal
• Headache
• Phlebitis (inflammation of a vein), thrombophlebitis (inflammation of the
vein related to a blood clot)
Rare: may affect up to 1 in 1,000 people
• When given in combination with other anti-cancer drugs, some
patients have developed cancers of white blood cells (leukaemia) after
completing treatment
• High levels of uric acid in the blood (indicator of cell destruction)
• Dizziness
• 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
• Hives (urticaria)
• Absence of menstrual periods, reduced or absent sperm in the semen
• Fever, chills, generally feeling unwell, unusual weakness
• Increased levels of liver enzymes (indicator of liver damage)
Other side effects (frequency cannot be estimated from the available data):
• Life-threatening illness caused by body overreacting to infection (sepsis),
sometimes with a dangerous drop in blood pressure with symptoms like
cold skin and increased heart beat (septic shock)
• Pneumonia (serious lung infection)
• Decrease in blood cell count may lead to bleeding and shortage of
oxygen to body tissues
• Discharge with itching of the eyes and crusty eyelids (conjunctivitis),
disease of the cornea with symptoms of eye irritation and having
something in the eye (keratitis)
• Shock (a dangerous decrease in blood pressure which may be lifethreatening; symptoms include rapid shallow breathing, cold clammy
skin, dizziness, weakness, fainting and a rapid weak pulse)
• Blockage of a blood vessel by a blood clot, including blood vessels in the
lungs (symptoms include: sudden severe headache, loss of vision, loss of
coordination, slurred speech, shortness of breath, chest pain, numbness,
heat or swelling in the arms and legs)
• Swelling, pain, ulcers or dark areas (pigmentation) in your mouth
• Rash, itch, skin changes, reddening of skin, dark areas (pigmentation) of
skin and nails
• Sensitivity or hypersensitivity to light
• Flushes (redness of the face and other areas of the skin)
• Thickening and hardening of veins, local pain and death of cells and
living tissue (tissue necrosis) if product accidentally administered outside
the vein
• Infection of the skin
Epirubicin may also affect your heart function, liver function and the
number of cells in your blood. Your doctor will monitor such effects with
regular heart and blood tests.
If epirubicin is injected directly into the bladder (intravesically) you may
experience an allergic reaction, pain or difficulty when passing urine or you
may experience a frequent urge to pass urine. Blood may also be seen in your
urine. If you notice either of these side effects, you should inform your doctor.
When given in combination with other anti-cancer drugs, some patients have
developed a secondary leukaemia after completing treatment. This is rare.

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
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Epirubicin
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Keep the vial in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the vial
label and outer carton after ‘EXP’. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Epirubicin contains

• The active substance is epirubicin hydrochloride.
• The other ingredients are sodium chloride, water for injections and
hydrochloric acid used as a pH adjuster.

What Epirubicin looks like and contents of the pack
Epirubicin is in the form of a solution for injection.

Each mililitre (ml) of solution contains 2 milligrams (mg) of epirubicin
hydrochloride. The medicine is presented in glass containers called vials,
containing 10 mg (5 ml), 20 mg (10 ml), 50 mg (25 ml) and 200 mg (100 ml)
of epirubicin hydrochloride.
The vials are available in packs of 1, 5 or 10 vials of 5 ml, 10 ml, 25 ml or 100 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer(s)

Haupt Pharma GmbH, Pfaffenrieder Strasse 5, 82 515 Wolfratshausen,
Germany
or
Laboratoires Thissen S.A - Rue de la Papyrée 2-6 B-1420 Braine-l'Alleud - Belgium
Or
MYLAN S.A.S., 117 allée des Parcs - 69800 SAINT-PRIEST, FRANCE.
This leaflet was last revised in January 2016

Other sources of information
Detailed information on this medicine is available on the website of
the MHRA.

The injection solution contains no preservative and any unused portion of
the vials 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 in a refrigerator (2°C - 8°C).
Keep the vial in the outer carton in order to protect from light.
In use: Epirubicin (hydrochloride) 2 mg/ml injection may be further diluted
as detailed above. The infusion solution is chemically stable when stored
in infusion bags prepared under full aseptically controlled conditions for
60 minutes at 25°C. 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 8°C unless dilution
has taken place in controlled and validated aseptic conditions.
736255

Description Epirubicin Hydrochloride 200 mg / 100 ml all
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 736255

SAP No. N/A

Superceded Affiliate Item Code 397775
TrackWise PR No. 736255
MA No. 04569/0983
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 265367
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 12 Jan 2016

Page Count 2/2

No. of colours 1
Colours

Time: 16:02

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 120 x 600mm

Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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