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MITOXANTRONE 2MG/ML STERILE CONCENTRATE

Active substance(s): MITOXANTRONE

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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.
2.
3.
4.
5.
6.

1.

What mitoxantrone is and what it is used for
Before you are given mitoxantrone
How mitoxantrone will be given to you
Possible side effects
How to store mitoxantrone
Further Information

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 nonHodgkin’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

DATE OF PREPARATION

June 2008

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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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