PACKAGE
LEAFLET
Doxorubicin 2mg/ml Concentrate for
Solution for Infusion
Doxorubicin Hydrochloride
Read all of this leaflet carefully
before you are given this medicine.
Keep this leaflet. You may need to
read it again.
If you have further questions, please
ask your doctor, nurse or
pharmacist.
In this
leaflet:
-
1. What is doxorubicin and what is it used for?
-
2. Before you are given doxorubicin
-
3. How doxorubicin will be given to you
-
4. Possible side effects
-
5. Storing doxorubicin
The active
substance in the injection is doxorubicin hydrochloride.
The other
ingredients are hydrochloric acid, sodium chloride and
water for injections.
1. WHAT
IS DOXORUBICIN 2MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION AND WHAT IS IT USED FOR?
The
concentrate for solution for infusion is a clear, blood
red solution, free of particles. The sterile solution is
supplied in clear glass vials with rubber stoppers. Each
vial contains either 10 mg or 50 mg of the active
ingredient, doxorubicin hydrochloride, in 5 ml or 25 ml,
respectively.
Doxorubicin
belongs to a group of medicines known as cytotoxics,
which are used in the treatment of cancer. Doxorubicin
may be used to treat leukaemia, lymphomas, sarcomas,
cancer in children and tumours (particularly in the
breast and lung).
2.
BEFORE YOU ARE GIVEN DOXORUBICIN 2MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSION
You should
not be given doxorubicin:
- if
you are allergic to doxorubicin or any of the other
ingredients
-
if you have problems with your bone marrow
-
if you have mouth ulcers or a sensation of
burning in the mouth after an earlier course of
doxorubicin
Your doctor
will take special care when giving you doxorubicin:
- if
you have recently had treatment with other cytotoxic
drugs or you are having radiotherapy
- if
you have heart problems
Consult your
doctor if any of the above warnings applies to you or
has applied to you in the past.
Your doctor
will check your blood before, during and after every
treatment cycle and will monitor your heart by giving
you an ECG test. If the results of any of these tests
are abnormal, treatment will only be resumed when all
readings are back to normal.
Pregnancy
Doxorubicin should not be given to you if you are
pregnant, because it may cause serious birth
defects.
Female
patients should also avoid getting pregnant while
being treated with doxorubicin and for at least six
months afterwards. Male patients receiving
doxorubicin should take adequate 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 doxorubicin
treatment is started.
Breast-feeding
Doxorubicin should not be given to you if you are
breast-feeding, because doxorubicin may pass into
breast milk and may 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
operating machinery until these have worn off.
Being given doxorubicin at the same time as other
medication
Tell
your doctor or pharmacist about medicines you are
currently taking or have taken recently. This also
applies to medicines you may have bought yourself
from a pharmacy or supermarket. Ciclosporin is an
example of a medicine which could affect
doxorubicin.
Doxorubicin 2mg/ml Concentrate for Solution for
Infusion contains 0.76mmol of sodium in a 5ml vial
and 3.84mmol of sodium in a 25ml vial. The amount of
sodium will need to be taken into consideration by
patients on a controlled sodium diet
3. HOW
DOXORUBICIN 2MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
WILL BE GIVEN TO YOU
Doxorubicin
will only be given to you under the supervision of a
doctor specialised in this type of treatment.
Doxorubicin
2mg/ml Concentrate for Solution for Infusion will be
administered by intravenous infusion after dilution
according to directions.
The usual
dose of doxorubicin in adults is 60 to 75 mg per square
metre of body surface area every three weeks. If
doxorubicin is given in combination with other cytotoxic
drugs then the dosage will be reduced to 30 to 40 mg per
square metre of body surface area every three weeks.
Alternatively, you may be given smaller doses of 20 to
25mg per square metre of body surface area every day for
three days at three week intervals, or 20mg per square
metre of body surface area once a week.
The total
dose you are given should not usually be more than
450-500 mg per square metre of body surface area.
Dosage will
be reduced in children and the elderly or in patients
with liver problems.
Your general
condition and your response to the treatment will be
closely observed before, during and after treatment.
4.
POSSIBLE SIDE EFFECTS
The most
common unwanted effects are nausea, vomiting and
diarrhoea. Hair loss is common and men with beards will
notice that their beards stop growing. All hair growth
will return to normal after finishing the course of
doxorubicin treatment.
You may
notice that your urine is red, particularly when
treatment is first started. Do not worry about this as
it will soon return to its normal colour.
Less
commonly, doxorubicin causes heart problems, with rapid
heart rate, heart failure, breathlessness, ankle
swelling, inflammation of mucous membranes, skin rashes,
fever, blood disorders, severe breathing problems,
hyperuricaemia (excessive amounts of uric acid in the
blood) and allergic reactions. Women may find that their
periods stop temporarily. Some patients have had bone
marrow problems, causing mouth ulcers, sore throat or a
tendency to bruise or bleed easily, fever, infections,
blood disorders (including infections of the blood),
skin problems and death. In rare cases, when used in
combination with other cytotoxic drugs, doxorubicin has
been known to cause leukaemia.
You may
notice stinging, burning, redness or swelling around the
injection site. You should let the person giving you the
injection know immediately If
this happens.
Doxorubicin
may harm unborn babies or cause miscarriage (see section
on pregnancy) and may also affect fertility in men and
women.
During the
treatment with doxorubicin your general condition will
be closely monitored.
If you
notice any side-effects not mentioned in this leaflet,
please tell your doctor, nurse or pharmacist.
5.
STORING DOXORUBICIN 2MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Keep out of
the reach and sight of children
Store at 2 -
8 °C. Keep the container in the outer carton.
Do not use
after the expiry date stated on the label or if there
any signs of deterioration such as discolouration.
For single
dose use only. Discard any unused solution immediately
after initial use.
When diluted
according to directions, product should be stored at
2-8°C for 24 hours
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