Patient leaflet - EPIRUBICIN HYDROCHLORIDE 2 MG / ML INTRAVESICAL SOLUTION/SOLUTION FOR INJECTION
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
Epirubicin is also used to help prevent recurrence of superficial bladder cancer after surgery.
2. what you need to know before you use epirubicin
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The following information is intended for healthcare professionals only:
Epirubicin 2 mg/ml Solution for Injection
epirubicin hydrochloride
FOR INTRAVENOUS INJECTION OR 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 “Dilutions Instructions” should be used.
Neither injection nor any diluted solutions should be mixed with any other drugs. Epirubicin should not be mixed with heparin due to physical incompatibility (precipitation).
Special care will also be taken if you are taking any of the following medicines:
- other medicines that may affect your heart for example, calcium channel blockers (e.g. verapamil, nifedipine and diltiazem), other cancer treatments such as mitomycin-C, dacarbazine, dactinomycin and possibly cyclophosphamide and 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)
- trastuzumab: epirubicin should not be taken within 27 weeks of taking trastuzumab
- 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 (a 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 or live-attenuated vaccines
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Epirubicin can cause severe harm to the unborn baby and effective contraception should be used during and until 6 months after treatment with this medicine.
If you are pregnant or become pregnant while receiving epirubicin, you should inform your doctor immediately.
You must not use epirubicin if you are breast-feeding.
Male patients may wish to seek advice on sperm preservation before treatment starts and should use effective contraceptive methods during treatment.
Male patients are advised not to father a child during and for 6 months after stopping epirubicin treatment.
Epirubicin may cause lack of menstrual cycles or premature menopause in premenopausal women.
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.
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.
Administration directly into a vein (injection or infusion)
The medicine will be given to you as an injection into a vein oven 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)
Epirubicin may be administrated directly in the bladder using a catheter. If this method is used, you should not drink any fluids for 12 hours before the 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. Occasionally you will need to alter your position 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 in 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 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 the drug, volume and time after which it should not be used.
If you use more Epirubicin 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.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dilutions Instructions
The injection may be given via the tubing of a free-running saline infusion. Where the injection is to be administrated after dilution, the following instruction should be followed.
Epirubicin Hikma may be further 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.
If any of the following rare side effects occur when Epirubicin is given by infusion into a vein, tell your doctor immediately:
- if there is any redness, pain or swelling where the injection has been given
- if you have chest pains, shortness of breath or swelling of your ankles (these effects may occur up to several weeks after finishing treatment with epirubicin)
- if you have a severe allergic reaction, noticed by feeling faint, skin rash, swelling of the face and difficulty in breathing or wheeze. In some cases collapse may occur.
5. how to store epirubicin
Store and transport refrigerated (2°C – 8°C). Store in the original container protected from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP: MM/YYYY. The expiry date refers to the last day of that month.
6. contents of the pack and other information
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Storage
Store and transport refrigerated (2°C – 8°C)
Store in the original container to protect from light
Chemical and physical stability was demonstrated, after dilution in Sodium Chloride 0.9% or Glucose 5% solution, for 72 hours when stored in a refrigerator. From a microbiological point of view, 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.