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ONKOTRONE INJECTION 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): MITOXANTRONE HYDROCHLORIDE

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In this leaflet:
1. What ONKOTRONE is and what it is used for
2. Before you are given ONKOTRONE
3. How you will be given ONKOTRONE
4. Possible side effects
5. How to store ONKOTRONE
6. Further information

1 What ONKOTRONE is and what it is used for
ONKOTRONE contains a medicine called mitoxantrone. It
is a cytotoxic drug or anti-cancer drug. It works by killing
cancer cells, this is sometimes called ‘chemotherapy’.
It is used to treat lots of different cancers. ONKOTRONE
is often used together with other anti-cancer drugs or
radiotherapy.

2 Before you are given ONKOTRONE
Do not have ONKOTRONE if:
• you have ever had an allergic reaction to the active
ingredient or any of the other ingredients (listed in
Section 6). An allergic reaction can include shortness of
breath, wheezing, rash, itching or swelling of the face
and lips.
• you are a child under 16 years of age
• you have severe liver problems
• you are pregnant, trying to become pregnant or are
breast feeding.

Tell your doctor if:
• you have a very bad infection (septicaemia)
• you have liver or kidney problems. Your doctor will
check how well your liver and kidneys are working by
doing a blood test
• you have heart problems.

Using other medicines and treatments
Tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines you have
obtained without a prescription.
In particular, tell them about the following medicines or
treatments as they may not work well with ONKOTRONE:
• medicines called ‘cytotoxic’ because the side effects,
especially on your bone marrow, are likely to be much
worse
• medicines called anti-cancer drugs or if you are having
radiotherapy, because this can cause a type of blood
cancer called ‘leukaemia’ or ‘acute myeloid leukaemia’
(AML)
• vaccines which contain a ‘live virus’. You should not
have these while having ONKOTRONE.

Contraception, pregnancy and breast-feeding
Do not become pregnant while taking ONKOTRONE. This
is because it can damage your unborn baby, leading to
stillbirths or a deformed child. Tell your doctor if you are
pregnant, think you might be pregnant or are trying to
become pregnant.

• Blood cells are made in your bone marrow. Three
different types of blood cell are made:
– red blood cells, which carry oxygen around your body
– white blood cells, which fight infection, and
– platelets, which help your blood to clot.
• After an injection of ONKOTRONE your blood count of
the three types of cell will drop. Your doctor will know
that your blood count will reach its lowest level about 6
to 15 days after your injection. Most people recover to
a normal blood count within 21 days. If you have had a
lot of chemotherapy in the past, your blood count may
take a little longer to return to normal.
• You may be more likely to get infections when your
blood count drops. Try to avoid close contact with
people who have coughs, colds and other infections. If
you do get an infection, speak to your doctor.
• Your doctor will check that your bone marrow cells
are high enough before and during treatment with
ONKOTRONE.
• ONKOTRONE may damage your heart, the more you are
given the more likely this is. Your doctor will carry out
tests, such as an ECG or ‘Muga’ scan before you start
your treatment. You may notice that your heart beat
changes, tell your doctor if this happens.
• You will also have blood tests during your treatment
with ONKOTRONE to check your blood cell levels or
blood count.

What to do if you see a different doctor, or
have to go to hospital
Do not take any other medicines unless your doctor
knows you are taking ONKOTRONE. If you see a different
doctor or have to go to hospital for any reason, tell them
that you are taking ONKOTRONE and about any other
medicines you are taking.

3 How you will be given ONKOTRONE
The usual dose
• Your doctor will decide how much of the medicine you
need and when you will need to be given it.
• ONKOTRONE will be diluted and then injected slowly
into a vein. This is called an infusion. It is often given
with other anti-cancer drugs or steroids. Sometimes it
is given at the same time as, or close to, radiotherapy
treatment.
• How it is given to you and how often will depend on:
– the type of cancer you have
– how big you are (a combination of your height and
weight)
– your general health
– whether you are being given other anti-cancer drugs
or having radiotherapy.
• The injection will usually take at least 5 minutes or
possibly up to half an hour depending on the dose.
• If you are not sure about how you will be given your
injection or have any other questions about your
treatment, ask your doctor, nurse or pharmacist.

If you think a dose of ONKOTRONE has been
missed
It is unlikely that you will miss a dose of ONKOTRONE,
because it is always given to you by a trained and
qualified person. If you do miss a dose, speak to your
doctor as soon as possible.

Turn over leaflet for further information.

ONKOTRONE Injection

This technical leaflet does not include all the information about the product. Refer to the Summary of Product Characteristics
before use.
Dosage and Administration
Intravenous application:
1. Advanced Breast Cancer, Non-Hodgkin’s Lymphoma, Hepatoma.
During monotherapy, a dose of 14 mg/m2 ONKOTRONE is recommended as the initial dose for the first cycle. This dose can be repeated
after 21 days.
In patients with diminished bone marrow reserves as a result of previous radiation and/or chemotherapy or those in a general poor
state of health, the initial dose should be reduced to 12 mg/m2 or as appropriate for the haematological status.
For each repeated application of ONKOTRONE, the dose should be adjusted in each case in accordance with the individual patient’s
progress and the extent and duration of myelosuppression. If leucocyte and platelet counts have returned to normal after 21 days then
the original dose can be repeated.
The following general recommendations can be given for dose adjustment in the treatment of advanced breast cancer,
non-Hodgkin’s lymphoma and hepatoma:
Lowest value (nadir) of leucocytes and platelets
(as a rule, 10 days after application)

Return to normal

Recommended dosage

> 1.5 x 109/l leucocytes and
> 50 x 109/l platelets
> 1.5 x 109/l leucocytes and
> 50 x 109/l platelets

21 days or less
More than 21 days

As previous dose or increase by 2 mg/m2 if
myelosuppression is not considered adequate.
Wait for return to normal, then as previous dose

< 1.5 x 109/l leucocytes or
< 50 x 109/l platelets
< 1.0 x 109/l leucocytes or
< 25 x 109/l platelets

Independent of return
to normal
Independent of return
to normal

Reduction of the previous dose by 2 mg/m2 after
recovery
Reduction of the previous dose by 4 mg/m2 after
recovery

2. Acute Non-Lymphocytic Leukaemia
For the induction treatment of acute leukaemia in adults, it is recommended to use a dose of 12 mg/m2 ONKOTRONE for five
consecutive days (total dose 60 mg/m2). Higher remission rates can be achieved after a daily dose of 12 mg/m2 for five days.
The higher dosage, however, should only be administered when the condition of the patient permits.


DATE

Tests you may have with ONKOTRONE

Pharmacist – please remove this section from leaflet
Technical Information

SIGNATURE

Effects on your blood and immune system

NAME

• 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 straightaway.
Throughout this leaflet, ONKOTRONE Injection 2 mg/ml
concentrate for solution for infusion will be called
ONKOTRONE.

RA/MKT

Read all of this leaflet carefully before you
are given this medicine.

COUNTRY

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
ONKOTRONE Injection 2 mg/ml
concentrate for solution for infusion
Mitoxantrone

• Men or women should not try to have a child during
treatment or for at least 6 months after treatment. You
should use an effective contraceptive. Ask your doctor
for advice.
• Some doctors recommend not trying to get pregnant for
one year after the end of treatment with ONKOTRONE.
This is because babies have a higher chance of being
born prematurely or being of low birth weight.
• Talk to your doctor about freezing sperm or eggs before
your treatment starts.
Do not breast-feed while you are having ONKOTRONE.

3rd DRAFT
PROOFREAD +
APPROVAL

b

• weakness, shortness of breath or yellowing of your skin
or eyes (jaundice)
• heart attack, blue coloured whites of your eyes, veins
or nails and loose nails. This discoloration will fade and
disappear after treatment stops.
• certain cancers of the blood (such as acute myeloid
leukaemia and myelodysplastic syndrome or MDS)
• changes in the results of laboratory tests for liver and
kidney function.

4 Possible side effects
Like all medicines, ONKOTRONE can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine.

DATE

Rare (affecting less than 1 in 1,000 people)

It is unlikely that you will be given too much ONKOTRONE,
because it is always given by a trained and qualified
person. If you think this has happened, you should speak
to your doctor or the hospital where it was given.

SIGNATURE

If you are given too much ONKOTRONE

• feeling sick and being sick. This can last for about
24 hours after the injection. However, there are very
effective anti-sickness medicines, which your doctor
will prescribe for you. This means that most people are
not troubled too much by sickness
• hair loss. You may just notice this as a little extra loss
of hair when you are combing or washing your hair,
or you may lose most or all of your hair. The amount
of hair which you lose will depend on the dose, the
thickness of your hair and whether you are also having
other anti-cancer drugs. If you are having ONKOTRONE
in combination with other anti-cancer drugs, you are
much more likely to lose your hair than if you are
having it alone
• tiredness and weakness
• fever (high temperature)
• women’s periods stop or sometimes heavier than
normal
• low sperm count

Common (affecting less than 1 in 10 people)
• a lowering of the white blood cell count (very common
in people with prostate cancer). You will probably not
notice any signs when your white blood cell count
drops, but you will be more likely to get infections.
• shortness of breath, pain and swelling of your gut and
mouth
• loss of appetite, diarrhoea, tummy pain, constipation
• blue coloured urine, feeling sleepy or confused
• fits (seizures or convulsions), stabbing pain, loss of
muscle strength (neuritis)
• tingling, pins-and-needles or numbness

Uncommon (affecting less than 1 in 100 people)
• heart failure and chest pain
• bleeding in your stomach. Signs may include black
stools that look like ‘tar’ or vomiting blood or bits that
look like coffee grounds
• serious infections (a high temperature, feeling cold and
shivery, or hot and sweaty, or any signs of infection
such as a cough, or stinging on passing water)
• difficulty breathing, liver problems (may include
yellowing of the skin and eyes and tenderness in the
stomach)

• Because ONKOTRONE is usually given in hospital it will
be stored safely and correctly by the hospital staff.
If you do need the storage conditions they are given
below.
• Keep out of the reach and sight of children.
• Do not use ONKOTRONE after the expiry date which is
stated on the label after EXP. The expiry date refers to
the last day of that month.
• Do not store above 25ºC.
• Do not freeze.
• Once opened, the vials can be used for 7 days if stored
as above.
• Diluted solutions can be stored as above for 4 days.
Medicines should not be disposed of via wastewater or
household waste. If you have any medicine left over, take
it back to your pharmacist.

6 Further information
What ONKOTRONE contains
The active substance is mitoxantrone hydrochloride.
The strength of ONKOTRONE is 2 mg mitoxantrone/ml.
Each vial contains 20 mg, 25 mg or 30 mg mitoxantrone
depending on the size of the vial.
The other ingredients are sodium chloride, sodium
acetate, acetic acid, sterile water (called ‘water for
injections’).

What ONKOTRONE looks like and contents of
the pack
ONKOTRONE is a dark blue solution in clear glass vials.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Send all enquiries to this address.
ONKOTRONE is manufactured by:
Baxter Oncology GmbH
Kantstrasse 2, 33790 Halle/Westfalen, Germany

This leaflet was last approved in 07/2008

For information about ONKOTRONE or
to request this leaflet in formats such
as audio or large print please contact
the Marketing Authorisation Holder:
Tel: 01635 206345.

Baxter and Onkotrone are trademarks of Baxter
International Inc.
ONKOTRONE combined with other cytotoxic agents has been successful in the treatment of acute non-lymphocytic leukaemia.
Most clinical experience has been with mitoxantrone combined with cytosine arabinoside. For induction, mitoxantrone has been given
at a dose of 10-12 mg/m2 for 3 days in combination with 100 mg/m2 of cytosine arabinoside for 7 days (by continuous infusion).
Combination therapy
The use of any cytotoxic agents, including cytosine arabinoside or etoposide, with mitoxantrone may cause greater myelosuppression
than when mitoxantrone is used alone. If ONKOTRONE is combined with other myelotoxic agents, it is advisable to reduce the initial
dose recommended for monotherapy by 2 to 4 mg/m2 ONKOTRONE.
Dose modification or prolongation of the dosage interval should be adjusted according to the clinical condition of the patient and the
haematological and non-haematological parameters. Reference to published literature should be made for information on dosage
modification/administration.
Mode and duration of application
ONKOTRONE should not be given intrathecally
ONKOTRONE should only be administered by experienced oncologists.
Intravenous application:
ONKOTRONE can be administered as a slow intravenous injection over not less than 5 min. The most appropriate way is to inject
ONKOTRONE diluted to at least 50 mls, slowly into a fast-running intravenous infusion. Isotonic saline or a 5% glucose solution are
suitable carrier solutions and diluent. ONKOTRONE should not be mixed with other drugs in the same solution.
ONKOTRONE can be infused for short periods (15-30 min). The calculated dose should be diluted with 50 to 100 ml of one of the above
mentioned infusion solutions.
If extravasation occurs, the administration should be stopped immediately and restarted using a different vein. To date, only isolated
cases of severe local reactions (necroses) have been described due to extravasation.
Marketing Authorisation number: PL 00116/0398
Further information on ONKOTRONE is available from the Marketing Authorisation holder:
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Telephone: 01635 206345
This leaflet was last revised in January 2008
Baxter and Onkotrone are trademarks of Baxter International Inc.

RA/MKT

5 How to store ONKOTRONE

COUNTRY

Very common (affecting more than 1 in 10
people)

• damage to your heart, finding that you pick up
infections very easily.
Although these side effects can be serious, your doctor
will have considered the risk of side effects with the risk
to you of your cancer. If you have any questions about
these side effects, or if you notice any other side effects
or problems, you should tell your doctor or pharmacist.

3rd DRAFT
PROOFREAD +
APPROVAL

• getting bruises without knocking yourself, or bleeding
from your gums. This may be caused by the platelet
levels in your blood getting too low
• your heart starts to beat very rapidly. This could be a
sign of heart damage within the first day after starting
ONKOTRONE
• very pale, lethargic and tired. This may be a sign of
low red blood cells (anaemia). Usually, no treatment
is required, your body will eventually replace the red
blood cells. If you are very anaemic, you may need a
blood transfusion
• sudden serious signs of allergy such as rash, itchy
skin, swelling of your face, lips or tongue, shortness of
breath, wheezing (anaphylactic shock).
Other possible side effects include:

NAME

Very rare (affecting less than 1 in 10,000 people)
Tell your doctor immediately, if you notice any
• injection site skin reactions such as damage to the skin
of the following serious side effects, you may
and phlebitis (tender blood vessel with area of hot red
need urgent medical treatment:
skin)

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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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