Mitoxantrone 2mg/Ml Sterile Concentrate
PACKAGE LEAFLET
Mitoxantrone 2mg/ml Sterile Concentrate
Mitoxantrone
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 further questions, please ask your doctor or your pharmacist.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What mitoxantrone is and what it is used for
2. Before you are given mitoxantrone
3. How mitoxantrone will be given to you
4. Possible side effects
5. How to store mitoxantrone
6. Further Information
1. WHAT MITOXANTRONE IS AND WHAT IT IS USED FOR
Mitoxantrone belongs to a group of medicines known as cytotoxics which are used in the treatment of cancer.
Mitoxantrone is used to treat advanced breast cancer, non-Hodgkins lymphoma and leukaemia (cancers of the blood).
Mitoxantrone works by interfering with the growth of cancer cells and gradually killing them.
2. BEFORE YOU ARE GIVEN MITOXANTRONE
You will not be given mitoxantrone:
• if you are allergic (hypersensitive) to mitoxantrone or any of the other ingredients of the injection.
Your doctor will take special care when giving you mitoxantrone:
• if you currently have or have had heart problems
• if you have recently had treatment with doxorubicin or other medicines for cancer or you are having radiotherapy
• if the person being given this medicine is under 12 years of age
• if you have problems with your bone marrow function
• if you are generally very run down
Your doctor will check your kidney function, liver function and blood before, during and after every treatment cycle and will monitor your heart by giving you an ECG test. Treatment will only be resumed when all readings are back to normal.
Taking other medicines
Taking or being given another medicine while you are receiving mitoxantrone can affect how it or the other medicines work.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy
Mitoxantrone should not be given to you if you are pregnant, as it may cause serious birth defects.
Women should also avoid getting pregnant for at least six months after being treated with mitoxantrone. Men receiving mitoxantrone should also take adequate contraceptive precautions to ensure that their partner does not become pregnant for the same period.
If you are considering becoming parents after the treatment, you should discuss this with your doctor.
Men who wish to father children in the future should seek advice about freezing sperm before the mitoxantrone treatment is started.
Breast-feeding
Mitoxantrone should not be given to you if you are breast-feeding, because mitoxantrone passes into breast milk and could affect the baby.
Driving and using machines:
If you are experiencing side-effects which could affect your ability to drive, you should avoid driving or using machines until these have worn off.
Important information about some of the ingredients of mitoxantrone
Mitoxantrone contains 0.74 mmol and 1.48mmol of sodium per 5ml and 10ml vial respectively. To be taken into consideration by patients on a controlled sodium diet.
3. HOW MITOXANTRONE WILL BE GIVEN TO YOU
Mitoxantrone will only be given to you under the supervision of a doctor specialised in this type of treatment. Your general condition and your response to the treatment will be closely monitored before, during and after treatment.
A doctor or nurse will give you mitoxantrone by slow injection or a drip, normally into a vein in your arm.
The amount of mitoxantrone you are given and how often you are given it will depend on the type of cancer being treated, whether other drugs are being used at the same time and the general state of your health.
The following information is a summary of how much mitoxantrone you will receive. Your doctor will be able to explain exactly what medicines you will be given and when.
When receiving mitoxantrone for advanced breast cancer or non-Hodgkin’s lymphoma:
You will usually receive a starting dose of 14mg per square metre of your body surface area when mitoxantrone is used by itself. This dose may be reduced, depending on your condition or if you have previously received other cancer treatments. Blood tests will help determine when mitoxantrone may be repeated. The time between treatments is normally not less than 21 days.
If mitoxantrone is used with other drugs the starting dose may be reduced to between 10 and 12mg per square metre of body surface area.
When receiving mitoxantrone for leukaemia:
You will usually receive a dose of 12mg per square metre of your body surface area once a day for five days. You may receive mitoxantrone in combination with other drugs. In these circumstances, the amount of mitoxantrone and number of days you receive it may be reduced.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, mitoxantrone can have side-effects.
Tell your doctor or nurse immediately if you notice any of the following:
• stinging, burning, redness or swelling around the place where the injection was given, as the injection may need to be stopped.
• difficulty in breathing, wheezing, swelling of the face, or skin rash, as you may be having a serious allergic reaction.
• symptoms of heart problems, such as rapid heart rate, shortness of breath or ankle swelling. These effects may occur up to several weeks after finishing mitoxantrone.
blood stained or black ‘tarry’ bowel motions.
• sore throat, mouth ulcers, fever, chills or aching muscles which could be signs of an infection
• unusual bleeding or bruising
• yellowing of your skin or eyes (jaundice).
Other side effects that you may experience include:
• blue/green colour of your urine, particularly when treatment is first started, which is nothing to worry about and should return to normal within 24 hours. There may also be a temporary blue discolouration of skin, nails and the white of the eyes.
• nausea (feeling sick), loss of appetite, vomiting, diarrhoea or constipation
• hair loss. All hair growth will return to normal after finishing the course of treatment.
• sore and weepy eyes (conjunctivitis)
• tiredness, confusion, anxiety or numbness and tingling in arms and legs
• bone marrow problems with a reduction in red or white blood cells.
• women may find that their periods stop temporarily
• high levels of uric acid in the blood
• reduced fertility in men and women
• In rare cases, when used in combination with other medicines for cancer drugs, mitoxantrone has been known to cause leukaemia.
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 MITOXANTRONE
Keep out of the reach and sight of children
The concentrate should be kept in the outer carton in order to protect from light, at a temperature not above 25oC.
The concentrate should not be used after the expiry date stated on the label. After dilution, the product should normally be used within 24 hours if stored at 2-8oC.
6. FURTHER INFORMATION What mitoxantrone contains
• The active substance is mitoxantrone hydrochloride
• The other ingredients are sodium chloride, sodium acetate, acetic acid,
sodium sulphate and water for injections.
What mitoxantrone looks like and contents of the pack
• The concentrate is a dark blue, aqueous solution.
• Mitoxantrone is available in 5ml and 10ml vials.
Marketing Authorisation Holder and Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg. KG Mondseestrasse 11 4866 Unterach Austria
June 2008
DATE OF PREPARATION