Epirubicin Hydrochloride 2 Mg/Ml Solution For Injection
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Epirubicin hydrochloride
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, 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.
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
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 in the treatment of:
• Cancer of the breast
• Cancer of the stomach
• Cancer of the ovaries
• Cancer of the lung (small cell lung cancer)
• It is used either alone or in combination with other anti-cancer medicines.
Epirubicin hydrochloride is also used intravesically to treat early (superficial) urinary bladder cancer and help prevent recurrence of bladder cancer after surgery.
2. BEFORE YOU USE EPIRUBICIN Do not use Epirubicin
• 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.
• 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 drugs 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 from or currently have problems with your heart
• if you have an acute 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:
• the cancer has penetrated the bladder wall
• you have an infection in your urine tract
• you have pain or inflammation in your bladder
• your doctor has problems inserting a catheter (tube) into your bladder
• you have a contracted bladder
• you have a large volume of urine left in your bladder after you empty it Special care will be taken:
• If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female.
• to make sure the number of white and red blood cells and platelets in your blood does not drop too low. Your doctor will check this regularly.
• if you notice a sensation of discomfort redness, pain or swelling close to or at the place of injection during the infusion (possible leakage into the surrounding tissue). Tell your doctor immediately.
• to check the level of uric acid in your blood. Your doctor will check this.
• to make sure that you have recovered from any inflammation of the mouth or gut before starting treatment with epirubicin
• if your liver or kidneys are not working properly.
• 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 or are receiving medications that might have side effects on your heart.
Using other medicine:
Special care will also be taken if you are taking any of the following medicines:
• other medicines that may affect your heart for example, medicines against cancer 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, calcium channel blockers used to control high blood pressure, chest pain, and irregular heartbeats and if you are receiving chest radiotherapy.
• other medicines that may affect your liver e.g barbiturates (drugs used in epilepsy or sleep disorders) and rifampicin ( a drug used to treat TB Tuberculosis)
• other medicines that may affect the bone marrow for example, other cancer treatments, sulphonamide, chloramphenicol (used to treat infection), diphenylhydantoin (used to treat epilepsy), amidopyrine-derivative (used to
relieve pain), antiretroviral agents (used to treat HIV infection) may alter the formation of blood cells
• cimetidine (a drug used to reduce the acid 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 (drug used for treatment of malaria and for leg cramps)
• 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
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without prescription.
Pregnancy and breast-feeding
Epirubicin may cause births defects, so it is important to tell your doctor if you think you are pregnant. You must not use Epirubicin during pregnancy unless clearly indicated by your doctor. Avoid becoming pregnant while you or your partner is taking Epirubicin as well as for 6 month after treatment. If pregnancy occurs during treatment with Epirubicin, genetic counsellation is recommended.
Men who wish to father children in the future should seek advice about freezing sperm before treatment with Epirubicin is started.
You must discontinue breast-feeding before and during therapy with Epirubicin. 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.
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
This medicinal product contains 3.54mg/ml of sodium and per vial the sodium content is as follows; 5ml vial 17.71mg, 10ml vial 35.42mg, 25ml vial 88.55mg, 50ml vial 177.1mg and 100ml vial 354.2mg . 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 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 60-90 mg/m body surface area.
Higher dosages (100-120 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 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.
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
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.
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 hydrochloride can cause side effects, although not everybody gets them.
If any of the following side effects happen when epirubicin is given by infusion into a vein tell your doctor immediately, as these are very serious side effects:
• redness, pain or swelling at the injection site; tissue damage may occur after accidental injection outside a vein
• Symptoms of heart problems such as chest pain, shortness of breath, swelling of your ankles (these effects may occiroccur up to several weeks after finishing treatment with epirubicin)
• Severe allergic reaction, symptoms include faintness, skin rash, swelling of the face and difficulty in breathing or wheeze. In some cases collapse may occur.
You may need urgent medical attention.
The following side-effects are possible for epirubicin hydrochloride and you should tell your doctor as soon as possible:
Very common (estimatedfrequency is more than 1 person out of 10):
• 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)
• Decreased number of platelets (thrombocytopenia)
• bleeding (haemorrhage) and tissue hypoxia (inadequate oxygen supply) as a result of myelosupression
• hair loss (alopecia) normally reversible
• lack of beard growth in males
• your urine may have a red color for up to two days after treatment.
This is normal and nothing to worry about
Common side effects (estimated frequency is less than 1 person out of 10 but more than 1 out of 100):
• allergic reactions
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• feeling very dry and thirsty (dehydration)
• loss of appetite
• abdominal pain
• inflammation of the oesophagus (oesophagitis)
• increased pigmentation (hyperpigmentation) of the oral mucosa
• hot flushes
• inflammation of a mucous membrane (mucositis)
• inflammation of the mucosa of the mouth with areas of painful erosions, ulceration and
bleeding stomatitis)
• redness along the infusion vein, local vein inflammation (phlebitis)
• thickening of the vein walls (phlebosclerosis)
• local pain and death of tissue (tissue necrosis) following accidental injection into the
surrounding tissue (paravenous injection)
• bladder inflammation with pain when passing urine (chemical cystitis), sometimes with
blood in the urine (haemorrhagic) following administration into the bladder
Uncommon side effects (estimated frequency is less than 1 person out of 100 but more than 1 out of 1000):
• sensitivity to light or hypersensitivity in the case of radiotherapy
• vein inflammation related to a blood clott (thrombophlebitis)
• increased pigmentation (hyperpigmentation) of skin and nails
• skin reddening
• headache
Rare side effects (estimated frequency is less than 1 person out of1000 but more than 1 out of 10, 000):
• 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)
• chills
• dizziness
• very high body temperature (hyperpyrexia)
• feeling of discomfort (malaise)
• weakness
• 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)
• malignant tumour of blood-forming tissue (secondary acute myeloid leukaemia), when
given in combination with other anti-cancer drugs.
If any of these 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 the medicinal product out of the reach and sight of children.
Do not use Epirubicin after the expiry date which is printed on the label and carton after EXP. The expiry date refers to the last day on that month.
Shelf Life before opening: 2 years Store in a refrigerator (2-8°C),
Keep the vial in the outer carton in order to protect from light.
From a microbiological point of view, the product upon opening should be used immediately and the remains discarded.
From a chemical and physical point of view, the product should be used immediately after dilution. Any unused portion must be discarded after use
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 contains
- The active substance is 2 mg/ml 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
A clear red solution for injection.
This medicinal product is available in glass packaging with a rubber stopper, called vials, with 10 mg (5 ml), 50 mg (25 ml), 100 mg (50 ml) and 200 mg (100 ml) epirubicin hydrochloride.
Pack sizes:
Glass vials containing 5ml, 10ml, 25ml, 50ml and 100ml supplied in the following pack sizes:
1 x 5 ml,1 x 10 ml, 1 x 25 ml, 1 x 50 ml, 1 x100 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Seacross Pharmaceuticals, Landmark House, 17 Hanover Square, Mayfair, London, W1S 1HU
Manufacturer
Genepharm S.A.
18th klm Marathonos Avenue, 153 51 Pallini Attikis Greece
This leaflet was last approved in To be completed upon approval
The following information is intended for medical or healthcare professionals only: Epirubicin 2 mg/ml, solution for injection
For Intravenous and Intravesical Administration
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. of the SPC.
Dilution Instructions
The injection may be given via the tubing of a free-running intravenous sodium chloride 0.9%infusion. Where the injection is to be administered after dilution, the following instructions should be followed.
Epirubicin solution for injection 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.
|
Dose Epirubicin required |
Volume of 2 mg/ml epirubicin injection |
Volume of diluent sterile sodium chloride |
Total volume for bladder installation |
|
30 mg |
15 ml |
35 ml |
50 ml |
|
50 mg |
25 ml |
25 ml |
50 ml |
|
80 mg |
40 ml |
10 ml |
50 ml |
Safe Handling
This is a cytotoxic product, please follow your local policy guidelines for instruction on the safe handling /disposal of cytotoxics.
Storage
Store at 2-8 oC
Keep vial in the outer carton.
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