DBL Bleomycin Sulfate Injection contains the active ingredient bleomycin sulfate.
DBL Bleomycin Sulfate Injection is a type of medicine called an anti-neoplastic/cytotoxic
agent/chemotherapy. It is used to treat cancer of the uterine cervix, penis, testes,
immune system, lymphatic system, skin, oesophagus, head, neck and some lung cancers.
2. What should I know before treatment with DBL Bleomycin Sulfate Injection?
You should not be given DBL Bleomycin Sulfate Injection if you have ever had an allergic
reaction to bleomycin sulfate.
Tell your doctor if you have kidney, liver, lung disease, are having or have had radiation
therapy, have had previous treatment for cancer, have lymphatic problems, had a recent
infection, take any other medicines; are pregnant, or you or your partner plan to
become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Bleomycin Sulfate Injection and affect how it
works. Examples include medicines to treat the heart, seizures/fits, cancer, oxygen
therapy and/or general anaesthetic during surgery or medicines to fight infections.
4. How is DBL Bleomycin Sulfate Injection given?
Your doctor will decide how you will receive the DBL Bleomycin Sulfate Injection,
how much you will be given and for how long.
5. What should I know while using DBL Bleomycin Sulfate Injection?
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Things you should do
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Talk to your doctor immediately if you experience certain side effects. Some side
effects may be experienced during or after stopping treatment.
Remind any doctor, nurse, dentist, surgeon, anaesthetist or pharmacist you visit that
you are being treated with DBL Bleomycin Sulfate Injection.
Tell your doctor immediately if you or your partner become pregnant.
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Driving or using machines
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Be careful until you know how DBL Bleomycin Sulfate Injection affects you.
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Looking after your medicine
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The hospital will store and dispose of the medicine.
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6. Are there any side effects?
Side effects include sudden cough and shortness of breath that may worsen to difficulty
breathing/wheezing with fatigue; fever; allergic reaction which may include swelling
of the face, lips, tongue or throat which may cause difficulty in swallowing and breathing;
chest pain; stroke or fit/seizure; easy bruising; headache with jaw pain; pain behind
ribs sometimes spreading to the neck and shoulders; nausea, vomiting or loss of appetite;
rash, itchy, swollen, tender, blisters, dry and scaly, peeling and bleeding skin;
altered pain sensation and altered skin colour; loss of hair; soreness or ulceration
of the mouth; blurry/distorted vision; numbness and color changes in fingers and toes;
disorientation or personality changes; unusual bleeding or bruising (including blood
in your bowel motions/urine); yellowing of the skin or eyes; pain and inflammation
at the injection site; painful urination, blood in the urine.
Active ingredient(s): Bleomycin Sulfate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Bleomycin Sulfate Injection.
You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using DBL Bleomycin Sulfate
Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Bleomycin Sulfate Injection?
DBL Bleomycin Sulfate injection contains the active ingredient bleomycin sulfate.
DBL Bleomycin Sulfate Injection is a type of medicine called an anti-neoplastic or
cytotoxic agent. You may hear it referred to as chemotherapy. DBL Bleomycin Sulfate
Injection works by blocking DNA production in cancer cells which weaken and destroy
them. This medication can be used alone or in combination with another anti-cancer
therapies.
DBL Bleomycin Sulfate Injection is used to treat cancer of the uterus cervix, penis,
testes, immune system, lymphatic system, skin, oesophagus, head, neck and some lung
cancers.
2. What should I know before treatment with DBL Bleomycin Sulfate Injection?
Warnings
You should not be given DBL Bleomycin Sulfate Injection if you have:
An allergy or sensitivity to bleomycin sulfate.
Severe lung problems or a lung infection
You have previously received one course of medicine and show signs of reduced lung
function or lung problems.
Check with your doctor if you:
have lung problems with reduced lung function
smoke or have smoked in the past
have kidney problems
have liver problems
have had previous treatment for cancer
have had or are having radiation therapy, especially to the chest
have lymphatic problems
have been exposed to an infection recently.
Your doctor may decide to delay your treatment until the infection has gone. A mild
illness, such as a cold, is not usually a reason to delay treatment.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
Check with your doctor if you are pregnant or you (or your partner) intend to become
pregnant.
DBL Bleomycin Sulfate Injection is potentially harmful to the fetus.
The use of DBL Bleomycin Sulfate injection should be avoided during pregnancy.
Both female and male patients must take effective measures to prevent pregnancy during
treatment and following the end of the treatment with DBL Bleomycin Sulfate injection.
Both female and male patients must consult with their healthcare provider about effective
contraception options before, during and on finishing treatment with DBL Bleomycin
Sulfate injection.
It is not known if DBL Bleomycin Sulfate injection may affect male and female fertility.
Check with your doctor for advice on fertility preservation before you begin treatment.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if DBL Bleomycin Sulfate Injection passes into breast milk and is therefore not recommended
while you are breast-feeding as there may be potential serious effects. It is recommended
that women should discontinue breastfeeding prior to treatment with DBL Bleomycin
Sulfate Injection.
Use in the elderly
There may be a greater chance of lung problems if you are over 70 years of age. Your
doctor will monitor you closely for this.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may effect or be affected by DBL Bleomycin Sulfate Injection. These
include:
medicine used to treat heart failure e.g. digoxin
medicine to prevent seizures/fits e.g. phenytoin
other medicines to also treat cancer e.g. cisplatin
other treatments for cancer e.g. radiation therapy or any other treatment which lowers
your immune system
general anaesthetics and/or oxygen therapy, which may be given to you during surgery
medicines used to help fight infections e.g. granulocyte colony stimulating factor
such as filgrastim.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect DBL Bleomycin Sulfate Injection.
4. How is DBL Bleomycin Sulfate Injection given?
How is DBL Bleomycin Sulfate Injection given
Your doctor will decide how you will receive the DBL Bleomycin Sulfate Injection and
the length of time in which you should receive it. You could be given DBL Bleomycin
Sulfate Injection in one of the following ways:
an intravenous infusion (as a slow drip into a vein)
an injection under the skin
an injection into a muscle
an injection into an artery, possibly in the chest
How much will be given
Your doctor will decide how and how much DBL Bleomycin Sulfate Injection you will
be given and how long you will be given it.
DBL Bleomycin Sulfate Injection may be given alone or in combination with other medicines.
The first time you are given DBL Bleomycin Sulfate Injection you may receive a small
test dose to check for any allergic response to bleomycin sulfate before receiving
the full dose.
If you are given too much DBL Bleomycin Sulfate Injection
Tell your doctor or nurse immediately if you are concerned that you may have been
given too much DBL Bleomycin Sulfate Injection.
As DBL Bleomycin Sulfate Injection is given under the close supervision of your doctor
it is very unlikely that you will receive too much. If you feel faint or experience
dizziness, a fever, a rapid pulse, rapid shallow breathing, or cold clammy skin alert
your doctor or nurse immediately as these may be signs of an overdose.
5. What should I know during treatment with DBL Bleomycin Sulfate Injection?
Things you should do
Keep follow up doctor’s appointments and attend any tests as directed. Treatment with
DBL Bleomycin Sulfate Injection requires your doctor to do some tests to check on
your progress and detect any adverse effects such as tests for the kidneys and liver.
DBL Bleomycin Sulfate injection is known to affect the way the lungs work in some
patients. These effects may be serious, therefore your doctor may arrange frequent
tests such as chest X-rays to check how well your lungs are working while you are
being treated. Tests may also be required after completion of treatment with DBL Bleomycin
Sulfate Injection to check your lungs are not adversely affected.
During treatment with DBL Bleomycin Sulfate Injection you may be at increased risk
of infection. Care should be taken to minimise cuts, impacts or exposure to infection.
Tell your doctor or nurse immediately if:
you plan to have surgery that needs a general anaesthetic
you are having radiation therapy
you, or your partner, become pregnant while you are being treated with DBL Bleomycin
Sulfate Injection.
During treatment with DBL Bleomycin Sulfate injection you may be at increased risk
of lung changes. Your doctor may determine if the changes are medicine related and
treatment needs to change.
Inform your doctor immediately if you experience:
sudden cough, or lightheadedness or shortness of breath.
chest pain
fits/seizures
allergic reaction with swelling of the face, lips, tongue or throat
unusual bleeding or bruising
yellowing of the skin or eyes
painful urination with or without blood in the urine.
Remind any doctor, nurse, dentist, surgeon, anaesthetist, or pharmacist you visit
that you are being treated with DBL Bleomycin Sulfate Injection.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Bleomycin
Sulfate Injection affects you.
Looking after your medicine
DBL Bleomycin Sulfate Injection will be stored appropriately at the hospital.
Getting rid of any unwanted medicine
The hospital staff will dispose of any leftover DBL Bleomycin Sulfate Injection.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If you are over 70 years of age you may have an increased chance of experiencing side
effects.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Some side effects (for example certain liver conditions, and blood abnormalities)
can only be found when your doctor does tests to check your progress.
Other side effects not listed here may occur in some people. Do not be alarmed by
this list of possible side effects. You may not experience any of them
After finishing it
The effects of bleomycin sulfate may take some time to occur and therefore any side
effects may not occur until months after DBL Bleomycin Sulfate is administered. Even
after you have finished receiving your DBL Bleomycin Sulfate treatment you should
tell your doctor immediately if you notice any of the side effects listed above.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
DBL Bleomycin Sulfate Injection contains:
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Active ingredient
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bleomycin sulfate 15,000 IU
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There are no other ingredients.
DBL™ Bleomycin Sulfate injection does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
What DBL Bleomycin Sulfate Injection looks like
DBL Bleomycin Sulfate injection is a cream to white coloured powder in a vial (AUST
R 42569).
Who distributes DBL Bleomycin Sulfate Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in December 2025.