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EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION

Active substance(s): EPIRUBICIN HYDROCHLORIDE / EPIRUBICIN HYDROCHLORIDE / 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, pharmacist or nurse.
• 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 is and what it is used for
2. What you need to know before you use Epirubicin
3. How to use Epirubicin
4. Possible side effects
5. How to store Epirubicin
6. 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 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:
• 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 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 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 (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 a severe infection.
You must discontinue breast feeding before being given Epirubicin.
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.
• your bladder is contracted

Warnings and precautions

Talk to your doctor, pharmacist or nurse 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 are elderly.

During treatment

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)
• if you are taking cimetidine (a medicine to reduce the acid in your stomach).
You must stop taking cimetidine during treatment with Epirubicin as the
amount of epirubicin in the blood is increased, which could lead to an increase
of the side effects
Special care is required for:
• standard doses of anthracyclines (for instance the anti-cancer medicines
mitomycin-C, dacarbazine, dactinomycin), or other medicines that may
affect the heart (for instance the anti-cancer medicines 5-fluorouracil,
cyclophosphaminde, cisplatin, taxanes) or calcium channel blockers (used to
treat high blood pressure or some heart conditions).
• The harmfulness to the heart can increase if these medicines are used before or
with Epirubicin. Extra monitoring of the heart is then necessary if you have been
given trastuzumab (a medicine used to treat certain cancers like breast cancer)
• rifampicin (a medicine used for the treatment of tuberculosis) and barbiturates
(medicines that are used for insomnia or epilepsy, such as for instance
phenobarbital); these medicines decrease the amount of epirubicin in the blood,
which could lead to a reduced effect of epirubicin.
• paclitaxel and docetaxel (medicines that are used for some cancers); when
paclitaxel is administered before epirubicin or docetaxel is administered
immediately after epirubicin, the amount of epirubicin in the blood is increased,
which could lead to an increase of the side effects.
• dexverapamil (a medicine that is used to treat some cardiac disorders); when
used together with epirubicin it may have a negative effect on bone marrow.
• interferon alpha-2b (a medicine used in some cancers and lymphomas and
some forms of hepatitis).
• quinine (a medicine used for treatment of malaria and for leg cramps); quinine
may speed up the distribution of epirubicin into the body, which may have a
negative effect on the red blood cells.
• dexrazoxane (a medicine sometimes used with doxorubicin to reduce the
risk of heart problems); the time that epirubicin is present in the body may be
decreased, which could lead to decreased effect of epirubicin.
• previous or concomitant treatment with other medicines which influence the
bone marrow (for instance other medicines to treat cancer, sulfonamide,
chloramphenicol, diphenylhydantoin, amidopyrine-derivate, medicines to
treat HIV/AIDS); the formation of blood cells can be disturbed.
• medicines that cause heart failure (speak to your doctor if you are not sure).
• medicines that influence the liver function (speak to your doctor if you are not
sure); the degradation of epirubicin by the liver may be influenced, which may
cause a reduced effect of epirubicin or an increase of the side effects.
• live vaccines; there is risk of fatal disease therefore this combination is not
recommended. Tell your doctor if you have recently been given or want to be
given any vaccination.
• ciclosporin (a medicine that suppresses the immune system); the immune
system may be suppressed too much.
Epirubicin can increase the effect of radiation and even after quite some time after
the radiation it can cause serious side effects in the irradiated area. Tell your doctor
if you have previously had or are scheduled to have radiotherapy.

Epirubicin with drink

You should not drink within 12 hours before application when epirubicin will be
administered in the bladder.

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.
Pregnancy
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.
Breast-feeding
It is not known whether epirubicin is excreted in the breast milk. You must
discontinue breast-feeding during treatment with Epirubicin.
Fertility
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 and kidney are 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:

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 2 mg / ml All
Component Type Leaflet
Affiliate Item Code 941161
Superceded Affiliate Item Code 736255
TrackWise PR No. 941161
MA No. N/A
Packing Site/Printer N/A
Supplier Code 723094 GB6

Pharma Code 4458
SAP No. N/A
Vendor Job No. 286290
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 03 Aug 2016

Page Count 1/2

No. of colours 1
Colours

Time: 12:14

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 120 x 600 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.
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 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 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 themedicine, volume and
the time after which it should not be used.
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 you notice any of the following side effects, tell your doctor straight away as
you may need urgent medical attention or hospitalisation:
Very common: may affect more than 1 in 10 people
• Bone marrow depression is an abnormality in the blood, which means that fewer
new blood cells are produced (resulting in a shortage of white blood cells, red
blood cells, platelets; reduced number of a type of white blood cell (neutrophilic
granulocytes) with fever), and which involves an increased sensitivity to
infections. Your blood must be checked regularly.
Uncommon: may affect up to 1 in 100 people
• Bruising and a tendency to bleed (due to shortage of platelets
(thrombocytopenia)).
Rare: may affect up to 1 in 1,000 people
• Severe and immediate allergic reaction (anaphylactic/anaphylactoid reaction)
with or without shock including faintness, swelling of the face, lips, tongue or
throat, difficulty breathing or swallowing, skin rash and itching; fever and chills.
• Risk of a reduced effect of the heart with as a result congestion of the blood
(congestive heart failure), heart failure (short of breath; accumulation of fluid
in the whole body (oedema), enlargement of the liver, accumulation of fluid in
the abdomen (ascites), accumulation of fluid in or around the lungs (pulmonary
oedema, pleural effusions), abnormal rhythm of the heart (gallop rhythm)
cardiotoxicity (e.g. ECG abnormalities, arrhythmias, heart muscle disease
(cardiomyopathy)).
• When epirubicin is used at the same time with certain anti-cancer medicines
(so-called DNA-damaging antineoplastic substances) can in rare cases lead to
certain forms of cancer of the blood (secondary acute myeloid leukaemia (AML)
with or without preleucaemic phase). These certain forms of cancer of the blood
can only be observed after 1-3 years.
• Extremely high fever.
Not known: frequency cannot be estimated from the available data
• Blood poisoning (sepsis) (with symptoms such as fever, chills and shivering, a fast
heartbeat, fast breathing) and shock as a result of blood poisoning sometimes
with a dangerous drop in blood pressure with symptoms like cold skin and
increased heart beat.
• Serious lungs infection with fever, chills, shortness of breath, cough, phlegm and
occasionally blood (pneumonia).
• Bleeding (haemorrhage), shortage of oxygen in tissue.
• Inflammation of the cornea (keratitis).
• Shock with symptoms such as a dangerous decrease in blood pressure which
may be life-threatening; rapid shallow breathing, cold clammy skin, dizziness,
weakness, fainting and a rapid weak pulse.
• Blockage of a blood vessel by a blood clot formed elsewhere in the body
(thromboembolism), including blood clot formation in the lungs (pulmonary
emboli, in very rare cases this resulted in death). Symptoms can include sudden
loss of vision, loss of coordination, slurred speech, shortness of breath, chest
pain, numbness heat or swelling in the arms and legs.
• Swollen, red area of skin that feels hot and tender/painful that can spread rapidly
to other parts of the body (severe cellulitis).
• Redness, pain or swelling at the injection site.

Other side effects:

Very common: may affect more than 1 in 10 people
• Hair loss (alopecia, in 60-90 % of treated cases). It involves poor beard growth
in men. Hair loss is related to how much epirubicin treatment you are given; in
most case hair normally regrows when your treatment course ends.
• Red coloration of urine for 1 to 2 days after administration.
Common: may affect up to 1 in 10 people
• Infection.
• Sudden feeling of feverish heat.
• Mucous membrane inflammation (mucositis (can occur 5 to 10 days after
the start of the treatment)), inflammation of the mucous membrane of the
oesophagus (oesophagitis), inflammation of the mucous membrane of the
mouth (stomatitis), vomiting, diarrhoea, dehydration, nausea (nausea and
vomiting often occur within the first 24 hours (in nearly all patients), loss of
appetite (anorexia).
• Bladder infection, inflammation of the bladder, sometimes bleeding, local
reactions like burning sensations and frequent urge to urinate have been
observed after administration into the bladder.
• Redness at infusion site.
Uncommon: may affect up to 1 in 100 people
• Redness along the veins (phlebitis), vascular inflammation with the forming of
a blood clot, often felt as a painful somewhat hard core with above it red skin
(thrombophlebitis).
• Headache
Rare: may affect up to 1 in 1,000 people
• Dizziness.
• Increased frequency of heart beat arising from lower chambers of the heart
(ventricular tachycardia), slow heart rhythm (bradycardia), cessation of
impulse transmission in the heart (AV block, bundle-branch block).
• Increased blood level of uric acid (hyperuricaemia).
• Absence of menstruation, lack of sperm cells in sperm.
• Generally feeling unwell, weakness, fever, chills and changes in levels of certain
enzymes (transaminase).
Not known: frequency cannot be estimated from the available data
• Inflammation of the eye (conjunctivitis).
• Decrease of fraction of blood pumped out of a ventricle with each heart beat
(asymptomatic drops in left ventricular ejection fraction).
• Thickening or hardening of the walls of the veins (phlebosclerosis).
• Local reactions, rash, itch, skin changes, redness, changes in skin and nail
(hyperpigmentation), sensitivity to light (photosensitivity) or allergic reaction in
the case of radiation (radiation-recall reaction).
• Swelling, pain, burning sensation, bleeding, ulcers or dark areas (pigmentation)
in your mouth.

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 July 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.
941161

723094 GB6

Description Epirubicin Hydrochloride 2 mg / ml All
Component Type Leaflet
Affiliate Item Code 941161
Superceded Affiliate Item Code 736255
TrackWise PR No. 941161
MA No. N/A
Packing Site/Printer N/A
Supplier Code 723094 GB6

Pharma Code 4458
SAP No. N/A
Vendor Job No. 286290
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 03 Aug 2016

Page Count 2/2

No. of colours 1
Colours

Time: 12:14

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 120 x 600 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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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