Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being treated with DBL Dacarbazine for Injection?
DBL Dacarbazine for Injection contains the active ingredient dacarbazine. DBL Dacarbazine
for Injection is used to treat some types of cancers: melanoma (skin cancer) that
have spread and sarcoma (cancer which occurs in bone and/or soft tissue).
2. What should I know before treatment with DBL Dacarbazine for Injection?
You should not be given DBL Dacarbazine for Injection if you have ever had an allergic
reaction to dacarbazine or any of the ingredients listed at the end of the CMI, are
pregnant, or are breastfeeding. Talk to your doctor if you have any other medical
conditions, take any other medicines, or plan to become pregnant.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Dacarbazine for Injection and affect how it
works.
4. How is DBL Dacarbazine for Injection given?
The dose of medicine given to you will depend on your condition, weight, height, how
well your kidneys and liver are working and whether you are being given any other
medicines at the same time.
5. What should I know while being treated with DBL Dacarbazine for Injection?
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Things you should do
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Remind any doctor, dentist, pharmacist and nurse who are treating you that you are
being given this medicine.
If you plan to be vaccinated within a year of being given DBL Dacarbazine for Injection,
tell the doctor before you are vaccinated.
Males should use effective contraception during and for at least 3 months after stopping
treatment. Females should use effective contraception while receiving this medicine
and for at least 6 months after stopping treatment. If you become pregnant while you
are being given DBL Dacarbazine for Injection, tell your doctor immediately.
Keep all of your doctor’s appointments so your progress can be checked.
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Things you should not do
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Do not breastfeed while you are being treated with DBL Dacarbazine for Injection.
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Driving or using machines
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Do not drive or operate machinery until you know how DBL Dacarbazine for Injection
affects you. Dacarbazine may affect your ability to drive or operate machinery as
it can cause nausea, vomiting, dizziness, tiredness and confusion in some people.
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6. Are there any side effects?
Side effects include nausea, vomiting, diarrhoea, skin rash or itching, hair loss,
headache, tiredness, flushing in the face, dizziness upon standing, blurred vision;
confusion; tingling, numbness of the skin or pins and needles sensation. Serious side
effects include severe allergic reaction (shortness of breath; wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching
or hives on the skin); signs of infection (fever, chills, muscle pain, sore or inflamed
mouth); unusual bleeding or bruising (including black stools, blood in your stools
or urine or pinpoint red spots on your skin); pain or irritation at the injection
site; seizures; severe abdominal pain or swelling and yellowing of the skin or eyeballs.
Active ingredient(s):
dacarbazine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Dacarbazine for 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 Dacarbazine for
Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Dacarbazine for Injection?
DBL Dacarbazine for Injection contains the active ingredient dacarbazine. DBL Dacarbazine for Injection belongs to a group of medicines known as antineoplastic
or cytotoxic agents. You may also hear it referred to as a chemotherapy medicine.
Dacarbazine works by killing cancer cells and stopping cancer cells from growing and
multiplying.
DBL Dacarbazine for Injection is used to treat some types of cancers: melanoma (skin
cancer) that have spread and sarcoma (cancer which occurs in bone and/or soft tissue).
2. What should I know before treatment with DBL Dacarbazine for Injection?
Warnings
DBL Dacarbazine for Injection should not be given to you if:
1. you are allergic to dacarbazine, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
2. you are pregnant or breastfeeding.
3. you have had any blood disorder with low numbers of red blood cells, white blood cells,
or platelets.
Check with your doctor if you have:
any problems with your liver.
any problems with your kidney.
an infection, including shingles and chickenpox or a recent exposure to chickenpox.
a low immune system due to other medicines or treatments.
Tell your doctor if you have an infection or high temperature.
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.
Tell your doctor or dentist if you intend having any dental work while being treated
with DBL Dacarbazine for Injection.
DBL Dacarbazine for Injection may increase the incidence of infection, delay healing
and gum bleeding. It is therefore recommended that any dental work be completed prior
to starting dacarbazine treatment or delayed until blood counts have returned to normal.
Tell your doctor if you intend to receive any vaccinations. Do not receive certain
vaccines while you are being treated with DBL Dacarbazine for Injection, and for at
least one year after you stop treatment.
DBL Dacarbazine for Injection may lower your body’s resistance and if you receive
certain vaccines with it, you may get the serious infection the vaccination is meant
to prevent.
In addition, other people in close contact with you (such as other persons living
in your home) should not take oral polio vaccine (sabin) since there is a chance they
could pass the polio virus on to you.
It may be helpful to restrict food intake for 4 - 6 hours prior to being treated with
DBL Dacarbazine for Injection as this may reduce the severity of nausea and vomiting
you may experience, especially during the first two days of treatment. Discuss medicines
that may also help with sickness with your doctor prior to treatment with DBL Dacarbazine
for Injection.
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 and breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant.
You should not be given DBL Dacarbazine for Injection if you are pregnant or intend
to become pregnant.
DBL Dacarbazine for Injection may cause birth defects. It is recommended that females
use effective contraception while receiving this medicine and for at least 6 months
after stopping treatment. Males should use effective contraception during and for
at least 3 months after stopping treatment.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not breastfeed while you are being treated with DBL Dacarbazine Injection.
It is not known whether dacarbazine passes into breast milk.
3. What if I am taking other medicines?
Tell your doctor, nurse 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/treatments may interfere with DBL Dacarbazine for Injection and affect
how it works.
any medicines which suppress your immune system such as azathioprine, ciclosporin
and tacrolimus.
some medicines used to treat gout, such as allopurinol.
medicines used to treat epilepsy such as phenytoin.
barbiturates (such as phenobarbitone, primidone and thiopental sodium) used to treat
seizures, help with sleep or as a general anaesthetic for surgery.
rifampicin, an antibiotic used to treat tuberculosis (TB).
levodopa, a medicine used in the treatment of Parkinson’s disease.
other medicines used to treat cancers (such as mercaptopurine, fotemustine or interleukin-2),
radiation therapy or any other treatment which lowers your immune system.
certain vaccines (such as live vaccines).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Dacarbazine for Injection.
4. How is DBL Dacarbazine for Injection given?
How much is given
Your doctor will decide what dose, how often and how long you will receive it. This
depends on your condition and other factors, such as your weight, height, how well
your kidneys and liver are working and whether you are being given any other medicines
at the same time.
How long it is given for
DBL Dacarbazine for Injection may be given alone or in combination with other drugs.
Several courses of dacarbazine therapy may be needed, depending on your response to
treatment. Additional treatment may not be repeated until your blood cell numbers
return to acceptable levels and any uncontrolled effects have been controlled.
How it is given
DBL Dacarbazine for Injection is given as slow infusion ("drip") into a vein by a
doctor or nurse over the period of about one minute.
If you believe you have been given too much DBL Dacarbazine for Injection
As DBL Dacarbazine for Injection will be given to you in hospital or under the supervision
of your doctor, it is very unlikely that you will receive an overdose.
If you think that you have been given too much DBL Dacarbazine for Injection or experience
severe side effects, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know during treatment with DBL Dacarbazine for Injection?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being given DBL Dacarbazine for Injection.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given this medicine.
If you are going to have surgery, tell the surgeon, anaesthetist or dentist that you
are taking this medicine. It may affect other medicines used during surgery.
If you plan to be vaccinated within a year of being given DBL Dacarbazine for Injection,
tell the doctor before you are vaccinated.
If you become pregnant while you are being given DBL Dacarbazine for Injection, tell
your doctor immediately.
Keep all of your doctor’s appointments, and ensure you have all tests your doctor
asks you to, so your progress can be checked.
Things you should not do
You should not breastfeed while you are being treated with DBL Dacarbazine for Injection.
Things to be careful of
DBL Dacarbazine for Injection can lower the number of white blood cells and platelets
in your blood. This means that you have an increased chance of getting an infection
or bleeding. The following precautions should be taken to reduce your risk of infection
or bleeding:
Avoid people who are unwell or have infections.
Be careful when using a toothbrush, dental floss or toothpick. Your doctor, dentist
or nurse may recommend other ways to clean your teeth and gums. Check with your doctor
before having any dental work done.
Be careful not to cut yourself when you are using sharp objects such as a safety razor
or fingernail or toenail cutters.
Avoid contact sports or other situations where bruising or injury may occur.
Your body breaks down dacarbazine and uses it to fight cancer. The breakdown products
may be excreted in body fluids and waste, including blood, urine, faeces, vomit and
semen.
In general, precautions to protect other people should be taken while you are receiving
chemotherapy and for one week after the treatment period by:
Flushing the toilet twice to dispose of any body fluids and waste.
Wearing gloves to clean any spill of body fluid or waste. Use paper towels or old
rags, a strong solution of non-bleaching detergent and large amounts of water to mop
up the spill. Discard the towels or rags into a separate waste bag and dispose of
fluids in the toilet.
Wash linen or clothing that is heavily contaminated by body fluids or waste separately
from other items. Use a strong solution of non-bleaching detergent and large amounts
of water.
Place soiled disposable nappies and other pads in a plastic bag, seal and dispose
into the garbage.
For sexual intercourse, use a barrier method such as a condom.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Dacarbazine
for Injection affects you.
DBL Dacarbazine for Injection may affect your ability to drive or operate machinery
as it can cause nausea, vomiting, dizziness, tiredness and confusion in some people.
Make sure you know how you react to dacarbazine before you drive a car, operate machinery,
or do anything else that could be dangerous.
Drinking alcohol
No information is available.
Looking after your medicine
DBL Dacarbazine for Injection will be stored appropriately in the hospital ward or
in the pharmacy.
6. Are there any side effects?
All medicines can have side effects. Some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Serious side effects
Tell your doctor or nurse or pharmacist if you notice anything else that may be making
you feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects (for example, changes in blood cell count, blood pressure,
heart and liver function) can only be found when your doctor does tests from time
to time to check your progress.
The benefits and side effects of dacarbazine may take some time to occur. Therefore,
even after you have finished your treatment with DBL Dacarbazine for Injection you
should tell your doctor immediately if you notice any of the side effects listed in
this section.
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/safety/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.
What DBL Dacarbazine for Injection contains
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Active ingredient
(main ingredient)
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dacarbazine
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Other ingredients
(inactive ingredients)
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citric acid monohydrate
mannitol
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Do not take this medicine if you are allergic to any of these ingredients.
What DBL Dacarbazine for Injection looks like
DBL Dacarbazine for Injection is a white or very pale yellow powder. It contains 200
mg dacarbazine supplied in an amber glass vial. It is available in single packs of
1 vial.
AUST R 39954.
Who distributes DBL Dacarbazine for Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in November 2024.
™ = Trademark