EPIRUBICIN HYDROCHLORIDE 2MG/ML SOLUTION FOR INJECTION

Active substance: EPIRUBICIN HYDROCHLORIDE

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1. WHAT EPIRUBICIN IS AND WHAT IT IS USED FOR
Epirubicin belongs to the therapeutic group of antineoplastic agents (medicine against cancer). It is used
either alone or in combination with other anti-cancer medicines.
Epirubicin is used in the treatment of:
• Breast cancer
• Stomach cancer

Epirubicin is often used concomitantly with other cancer fighting medicinal products (in so-called
polychemotherapy schedules).

Pregnancy and breast-feeding:
Pregnancy
Medicines to fight cancer are only administered during pregnancy in extreme cases. The benefits for the
mother must be weighed against the possible danger to the unborn child. In animal studies epirubicin
proved to be harmful to the unborn child and can cause deformities. Both men and women should use
good contraceptive measures (pill, condom) both during and for 6 months after the use of this medicine
to prevent the pregnancy.

2. BEFORE YOU USE EPIRUBICIN

You should also prevent pregnancy if your partner is treated with epirubicin.

Do not use Epirubicin
• if you are allergic (hypersensitivity) to epirubicin or any of the other ingredients of Epirubicin or to any
other similar medicine (belonging to a group of medicines called anthracyclines [e.g. doxorubicin and
daunorubicin] or anthracenediones)
• if you have fewer blood cells than normal caused by previous treatment with other antitumour drugs or
by previous radiotherapy. Your doctor will check this.
• if you have been treated with the maximum dose of some other anti-cancer medicines including
doxorubicin and daunorubicin which belong to the same group of drugs as epirubicin (called
anthracyclines). These medicines have similar side effects (including those effects on the heart).
• if you have suffered or currently have problems with your heart
• if you have an acute severe infection
• if you have severe liver problems
• if you are breast feeding.

If pregnancy occurs during treatment with epirubicin, genetic counselling is recommended.

Epirubicin is also used intravesically to treat early (superficial) urinary bladder cancer and help prevent
recurrence of bladder cancer after surgery.”

When administered intravesically (directly into the bladder), do not use epirubicin:
• if the cancer has penetrated the bladder wall
• if you have an infection in your urine tract
• if you have pain or inflammation in your bladder
• if there is a large volume of urine left in your bladder after you attempt to empty it
• if you have a contracted bladder
• if your urine contains blood
• if you have catheterisation problems.
Take special care with epirubicin:
• to ensure the numbers of white and red blood cells and platelets do not drop too low. 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 check this.
• if your liver and kidneys are not working properly This may cause an increase in side effects. Both the
kidney function and the liver function will be checked regularly and if needed the dose will be adjusted.
• to ensure your heart is working properly. The dose of epirubicin will have to be adjusted. Your doctor
will regularly check this.
• if you have received or are receiving radiotherapy to the chest area or are receiving medications that
might have side effects on your heart.
• if you notice a sensation of discomfort close to or at the injection site during the infusion (possible
leakage in the surrounding tissue). Tell your doctor immediately.
• if you desire to have children. Both men and women should use effective contraceptive measures
both during and for 6 months after the treatment. Men are advised to request information about the
possibility of storing sperm by means of freezing before the treatment.
• if you are elderly or a child, because of the higher risk of severe cardiac side effects. Your cardiac
function will be checked before and after the treatment with epirubicin.
• If you have previously been treated with products to fight cancer (such as with doxorubicin or
daunorubicin or anthracenedion derivatives) or if you have had radiation, because the risk of severe
cardiac side effects is greater. Inform your doctor because this is included in determining the total dose
of epirubicin you will be administered.
• If you suffer from infections or bleedings. Epirubicin may affect the bone marrow. The number of white
blood cells in your blood will be reduced, which makes you more susceptible to infections (leucopoenia).
Bleedings can occur more easily (thrombocytopenia). These side effects are temporary in nature. The
reduction of the number of white blood cells is greatest 10-14 days after the administration and usually
returns to normal 21 days after the administration.
• If you have recently received or want to receive any vaccination.
• if you have severe inflammation of the mouth, throat, gullet and gastrointestinal tract.
Please consult your doctor if one of the above mentioned warning is applicable to you, or has been
applicable to you in the past.
Taking other medicines:
Please tell your doctor or pharmacist if you have recently taken any other medicines, even those not
prescribed, particularly the following:
• Cimetidine (a drug usually used to treat stomach ulcers and heartburn). Cimetidine can make the
effects of epirubicin stronger

Epirubicin Pack insert - UK-IE - Bordon.indd 1

Men who wish to father children in the future should seek advice about freezing sperm before treatment
with epirubicin is started.
Breast-feeding
You should stop breast feeding before starting treatment with this medicine as some of the drug may get
into your milk and possibly harm your child.
Ask your doctor or pharmacist for advice before taking any medicine whilst breast feeding.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed with epirubicin.
However, epirubicin may cause nausea and vomiting, which can temporarily affect your ability to drive
and use machines.
Important information about some of the ingredients of Epirubicin hydrochloride
2 mg/ml Solution for Injection or Infusion
This medicinal product contains 3.5 mg of sodium per ml of solution for injection. The different package
sizes of epirubicin contain the following amount of sodium:
-- 1 vial of 5 ml solution contains 17.7 mg sodium.
-- 1 vial of 25 ml solution contains 88.5 mg sodium.
-- 1 vial of 50 ml solution contains 177.0 mg sodium.
-- 1vial of 100 ml solution contains 354.1 mg sodium.
To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE EPIRUBICIN
Epirubicin will only be given to you under supervision of a doctor specialised in this type of treatment.
Before and during treatment with epirubicin, your doctor will check various laboratory parameters (e.g.
blood cell count, blood uric acid level, your liver function and kidney function) and carefully monitor your
heart function. Monitoring of the heart function will be continued for several weeks following the end of
treatment with epirubicin.
When given by injection or infusion into a vein
Each dose of epirubicin is based on your body surface area. This is calculated from your height and
weight. The dose of epirubicin given to you will also depend on the type of cancer you have, your health,
how well your liver or kidney is working and any other medicines you may be taking.
When given as a single agent, the usual dose is 60 mg/m2 to 90 mg/m2 body surface area. Higher dosages
(100 mg/m2 to 120 mg/m2 body surface area) may be given to you if you suffer from breast cancer.
Dosage will be reduced or the following dose could be delayed if you have a low level of white blood cells
in your body, if you are elderly, if you have liver problems, or if the drug is used in combination with other
anticancer drugs.

Epirubicin hydrochloride 2 mg/ ml Solution for
Injection or Infusion
(Epirubicin hydrochloride)
IMPORTANT: Refer to Summary of Product
Characteristics before prescribing.
Intravenous administration. Epirubicin should be
administered into the tubing of a freely flowing intravenous
infusion (0.9% sodium chloride or 5% glucose). To minimize
the risk of thrombosis or perivenous extravasation, the
usual infusion times range between 3 and 20 minutes
depending upon dosage and volume of the infusion
solution. A direct push injection is not recommended due
to the risk of extravasation, which may occur even in the
presence of adequate blood return upon needle aspiration
(see Warning and Precautions).
Discard any unused solution.
Intravesical administration. Epirubicin should be instilled
using a catheter and retained intravesically for 1-2 hour.
During instillation, the patient should be rotated to ensure
that the vesical mucosa of the pelvis receives the most
extensive contact with the solution. To avoid undue dilution
with urine, the patient should be instructed not to drink any
fluid in the 12 hours prior to instillation. The patient should
be instructed to void at the end of the instillation.
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 a
mobile solution after two to a maximum of four hours
equilibration at controlled room temperature (15–25°C).
Protective measures: The following protective
recommendations are given due to the toxic nature of this
substance:
Personnel should be trained in good technique for
reconstitution and handling.
• Pregnant staff should be excluded from working with this
drug.
• Personnel handling epirubicin should wear protective
clothing: goggles, gowns and disposable gloves and
masks.
• A designated area should be defined for reconstitution
(preferably under a laminar flow system); the work
surface should be protected by disposable, plasticbacked, absorbent paper.
• All items used for reconstitution, administration or
cleaning, including gloves, should be placed in high-risk,
waste disposal bags for high temperature incineration.
Spillage or leakage should be treated with dilute sodium
hypochlorite (1% available chlorine) solution, preferably
by soaking, and then water.
• All cleaning materials should be disposed of as indicated
previously.
• In case of skin contact thoroughly wash the affected area
with soap and water or sodium bicarbonate solution.
However, do not abrade the skin by using a scrub brush.
In case of contact with the eye(s), hold back the eyelid
of the affected eye(s) and flush with copious amounts
of water for at least 15 minutes. Then seek medical
evaluation by a physician.
• Always wash hands after removing gloves.

Dimension: 300 x 340 mm

In this leaflet:
1. What epirubicin is and what it is used for
2. Before you use epirubicin
3. How to use epirubicin
4. Possible side effects
5. How to store epirubicin
6. Further Information

A GUIDE FOR HOSPITAL STAFF

Disposal
Any unused product or waste material should be disposed
of in accordance with local requirements.

Epirubicin 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. Usually it will be given to you every 3 (or 4) weeks.
The needle must remain in the vein while epirubicin is being given. If the needle comes out or becomes
loose, or the solution is going into the tissue outside the vein (you may feel discomfort or pain) – tell the
doctor or nurse immediately.
When given directly into the bladder (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 dose will depend upon the type of bladder cancer.
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.
If you received more Epirubicin than you should
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too much,
however, tell your doctor or pharmacist if you have any concerns.

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Read all of this leaflet carefully before you start using this medicine.
-- Keep this leaflet. You may need to read it again.
-- If you have any further questions, please ask your doctor or pharmacist.
-- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
-- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

The following information is intended for medical and
healthcare professional only:

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(Epirubicin hydrochloride)

• other medicines that may affect your heart, for example other medicines against cancer (e.g.
5-fluorouracil, cyclophosphamide, cisplatin, taxanes), calcium channel blockers (used to control high
blood pressure, chest pain, and irregular heart beat), or concomitant (or prior) radiotherapy to the
mediastinal area.
• Quinine (a drug used for treatment of malaria and for leg cramps)
• Other medicines that may affect the bone marrow, e.g. other cancer treatments, sulphonamide,
chloramphenicol (used to treat infection), diphenylhydantoin (used to treat epilepsy), amidopyrinederivate (used to relieve pain), antiretroviral agents (used to treat HIV-infection).
• other medicines that may affect your liver, e.g. barbiturates (used to treat epilepsy) or rifampicin (used
to treat tuberculosis).
• 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)
• dexrazoxane (a drug sometimes used with doxorubicin to reduce the risk of heart problems)
• dexverapamil (a drug used to treat some heart conditions)
• live attenuated vaccines
• Prior or concomitant administration of other products related to epirubicin (so-called anthracyclines;
(for instance the cancer fighting medicine mitomycin-C, dacarbazine, dactinomycin and
cyclophosphamide);), other medicines that may affect the heart ( for instance the cancer fighting
medicine 5-fluorouracil, cyclophosphamide, cisplatin, taxanes); the harmfulness to the heart can
increase. Extra monitoring of the heart is then necessary.
• Cyclosporine (a product that suppress the immune system); the immune system may be suppressed
too much.

XXXXXXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER
Epirubicin hydrochloride 2 mg/ ml Solution for Injection or Infusion

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, epirubicin can cause side effects, although not everybody gets them.
If any of the following happen when epirubicin is given into a vein, tell your doctor immediately:
• any redness, pain or swelling at the injection site. Tissue damage may occur after accidental injection
outside the vein.
• symptoms of heart problems such as chest pain, shortness of breath, swelling of your ankles (these
effects may occur up to several weeks after finishing treatment with Epirubicin).
• severe allergic reaction, symptoms include faintness, skin rash, itching, fever, chills, swelling of the
face and difficulty in breathing of wheeze. In some cases collapse may occur.
These are very serious side effects. You may need urgent medical attention.
The following side effects may also occur:
Side effects may appear very common (in more than 1 in 10 patients);
common (in more than 1 in 100, but less than 1 in 10 patients);
uncommon (in more than 1 in 1,000, but less than 1 in 100 patients);
rare (in more than 1 in 10,000, but less than 1 in 1,000 patients);
very rare (in less than 1 in 10,000 patients);
not known (cannot be estimated from the available data).
Very common:
• inhibition of blood cell production in the bone marrow (myelosuppression)
• decreased number of white blood cells (leucocytopenia)
• decreased number of a special form of white blood cells (granulocytopenia and neutropenia)
• neutropenia accompanied by fever (febrile neutropenia)
• decrease in red blood cells (anaemia)
• bleeding (haemorrhage) and tissue hypoxia (inadequate oxygen supply) as a result of myelosuppression
• hair loss (alopecia) normally reversible
• lack of beard growth in males
• your urine may have a red colour for up to two days after treatment. This is normal and nothing to
worry about

Dimension: 300 x 340 mm

Common:
• allergic reactions
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• feeling very dry and thirsty (dehydration)
• loss of appetite
• abdominal pain
• hot flushes
• inflammation of the mucosa of the mouth with areas of painful erosions, ulceration and bleeding
(stomatitis), inflammation of a mucous membrane (mucositis)
• redness along the infusion vein, local vein inflammation (phlebitis)
• thickening of the vein walls (phlebosclerosis)
• bladder inflammation with pain when passing urine (chemical cystitis), sometimes with blood in the
urine (haemorrhagic) following administration into the bladder
• headache, dizziness (disorientation), injury of peripheral nerves characterised by a creeping sensation,
numbness and/or pain in hands and/or feet (peripheral neuropathy).
• If epirubicin leaks outside the vein (extravasation) it may lead to a severe inflammation of the
subcutaneous connective tissue (cellulitis), blister formation and local tissue death.
Uncommon:
• decreased number of platelets (thrombocytopenia)
• sensitivity to light or hypersensitivity in the case of radiotherapy
• vein inflammation related to a blood clot (thrombophlebitis)
• increased pigmentation (hyperpigmentation) of skin and nails
• skin reddening
• headache

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Rare:
• severe hypersensitivity (anaphylaxis) with or without shock including skin rash, pruritus (itching), fever
and chills
• ECG-changes
• rapid heart rate (tachycardia)
• slow heart rate (bradycardia)
• special forms of arrhythmia (AV block and bundle-branch block)
• third heart sound (gallop rhythm)
• heart muscle disease (cardiomyopathy)
• difficulty in breathing (dyspnoea)
• accumulation of fluid (oedema)
• enlargement of the liver
• accumulation of fluid in the abdominal cavity (ascites)
• lung oedema
• accumulation of fluid between thorax and lung (pleural effusions)
• urticaria (hives), or with severe itching (pruritis), redness along the vein that was used for the injection
• chills
• dizziness
• very high body temperature (hyperpyrexia)
• feeling of discomfort (malaise)
• weakness

Epirubicin Pack insert - UK-IE - Bordon.indd 2

absence of menstruation (amenorrhea)
lack of sperm in the semen (azoospermia)
increased levels of liver enzymes (transaminases)
increased levels of uric acid in the blood (hyperuricaemia) as a result of rapid lysis of cancer cells
malignant tumour of blood-forming tissue (secondary acute myeloid leukaemia), when given in
combination with other anti-cancer drugs.
• Inflammation of the mucous membrane of the oesophagus (oesophagitis), pigmentation in the mouth.
Frequency unknown:
• fever, infections, inflammation of the lungs (pneumonia), blood poisoning (sepsis) or a state of shock
resulting from blood poisoning (septic shock) may occur.
• occlusion of blood vessel due to a blood clot (thromboembolic events) including occlusion of a blood
vessel in the lungs (pulmonary embolism [in isolated cases with fatal outcome])
• Urine turns turbid (proteinuria)
• Certain disorder of the nerves (peripheral neuropathy), headache.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE EPIRUBICIN
Keep out of the reach and sight of children.
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep vial in the outer carton in order to protect from
light.
Do not use epirubicin after the expiry date which is stated on the carton after EXP. The expiry date refers
to the last day of that month. The pharmacist will check this when your medicine is prepared for you. If the
solution is cloudy after preparation, the pharmacist will dispose of it safely.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Epirubicin hydrochloride 2 mg/ml Solution for Injection contains
The active substance is epirubicin hydrochloride.Each ml of solution for injection or infusion contains 2
mg of epirubicin hydrochloride.
The other ingredients are hydrochloric acid, sodium chloride and water for injections.
What Epirubicin hydrochloride 2 mg/ml Solution for Injection or Infusion looks like and contents
of the pack
Epirubicin contains 10 mg, 50 mg, 100 mg and 200 mg of the active ingredient, epirubicin hydrochloride
in single glass vials.
Pack sizes:1 x 5 ml vial
1 x 25 ml vial
1 x 50 ml vial
1 x 100 ml vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road
Bordon, Hampshire GU35 0NF
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Belgium
Bulgaria
Cyprus
Czech
Denmark
Estonia
Finland
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithunian
Luxemburg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovak
Slovenia
Spain
Sweden
UK

Epirubicin Kabi 2 mg/ml Injektions- oder Infusionslösung
Epirubicinehydrochloride Fresenius Kabi 2 mg/ml oplossing voor injectie of infusie
Епирубицин Каби 2 mg/ml инфузионен разтвор
Epirubicin Kabi 2 mg/ml διάλυμα για ένεση ή έγχυση
Epirubicin Kabi 2 mg/ml
Epirubicin ”Fresenius Kabi”
Epirubicin Kabi 2 mg/ml
Epirubicin Fresenius Kabi 2 mg/ml injektio/ infuusioneste, liuos
Epirubicin Kabi 2 mg/ml Injektions- oder Infusionslösung
Epirubicin/Kabi 2 mg/ml διάλυμα για ένεση ή έγχυση
Epirubicin Kabi 2 mg/ml oldatos injekció vagy infúzió
Epirubicin hydrochloride 2 mg/ml Solution for Injection or Infusion
Epirubicina Kabi 2 mg/ml soluzione iniettabile
Epirubicin Kabi 2 mg/ml šķīdums injekcijām/ infūzijām
Epirubicin Kabi 2 mg/ml injekcinis/ infuzinis tirpalas
Epirubicin Kabi 2 mg/ml Injektions- oder Infusionslösung
Epirubicin hydrochloride 2 mg/ml Solution for Injection or Infusion
Epirubicinehydrochloride Fresenius Kabi 2 mg/ml oplossing voor injectie of infusie
Epirubicin Fresenius Kabi 2 mg/ml injeksjonsvæske/ infusjonsvæske, oppløsning
Epirubicin Kabi
Epirrubicina Kabi
Epirubicina Kabi 2 mg/ml soluţie injectabilă/ perfuzabilă
Epirubicin Kabi 2 mg/ml
Epirubicin Kabi 2 mg/ml raztopina za injiciranje/infundiranje
Epirubicina Kabi 2 mg/ml solución inyectable o para perfusión
Epirubicin Fresenius Kabi, 2 mg/ml injektions-/ infusionsvätska, lösning
Epirubicin hydrochloride 2 mg/ml Solution for Injection or Infusion

This leaflet was last approved in January 2012.
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If you stop treatment with Epirubicin
Stopping your treatment with epirubicin may stop the effect on tumour growth. Do not stop treatment with
epirubicin unless you have discussed this with your doctor.







XXXXXXXXXX

If you missed a dose of Epirubicin
Epirubicin needs to be given on a fixed schedule. Be sure to keep all appointments. If you miss a dose,
you should discuss this with your doctor. Your doctor will decide when you should be given your next
dose of epirubicin.

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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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