DBL Vincristine Sulfate Injection contains the active ingredient vincristine sulfate.
DBL Vincristine Sulfate Injection is used to treat certain cancers, including acute
leukaemia, Hodgkin's disease, non-Hodgkin's disease, rhabdomyosarcoma, neuroblastoma,
Wilm's tumour, bone cancer, mycosis fungoides, Ewing's sarcoma, uterine or cervical
cancer, breast cancer, malignant melanoma, lung cancer, gynaecological childhood tumours.
2. What should I know before receiving DBL Vincristine Sulfate Injection?
Do not use if you have ever had an allergic reaction to vincristine or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions such as the demyelinating
form of Charcot-Marie-Tooth-Syndrome, take any other medicines, if you are currently
receiving or have received radiation therapy to areas that include the liver or are
pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Vincristine Sulfate Injection and affect how
it works.
4. How is DBL Vincristine Sulfate Injection given?
Your doctor will decide what dose, how often and how long you will receive this medicine.
DBL Vincristine Sulfate Injection is given as a slow injection into a vein and must
only be given by a doctor or nurse.
5. What should I know while receiving DBL Vincristine Sulfate Injection?
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Things you should do
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Remind any doctor, dentist, nurse or pharmacist you visit that you are receiving this
medicine.
DBL Vincristine Sulfate Injection can increase your risk of infection and bleeding.
It can be excreted in your body fluids and waste. Information on how to reduce your
risk and protect others can be found in the full CMI.
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Things you should not do
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Do not have any immunisations or vaccinations without your doctor's approval and for
up to 12 months after you stop treatment.
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Driving or using machines
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Be careful driving or operating machinery until you know how vincristine affects you.
This medicine may cause dizziness, tiredness or affect vision or movement in some
people.
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Looking after your medicine
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DBL Vincristine Sulfate Injection will be stored in the pharmacy or on the ward.
It must be kept in a refrigerator, where the temperature stays between 2-8°C.
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6. Are there any side effects?
Side effects of this medicine include: hair loss; diarrhoea, nausea, vomiting; loss
of appetite, weight loss; headache; unusual perspiration; increased sunburn; tingling
or burning sensation; inflamed gums; impotence or reduced sexual drive; dizziness
or light-headedness; constipation; loss of feeling, hearing or taste; difficulty walking;
muscle wasting, aches or spasms; mouth ulcers; different urination frequency; jaw,
bone, limb or back pain; vision problems; trouble sleeping, depression, nervousness,
hallucinations, confusion or personality changes; tightness or pain in the chest,
neck, back or arms and abnormal heartbeat; signs of allergy; difficulty breathing;
signs of infection; unusual bleeding or bruising; abdominal or stomach cramps; abdominal
pain or swelling, sudden weight gain; yellowing of the skin and eyes; loss of movement
or coordination; fits. For more information, including what to do if you have any
side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
vincristine sulfate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Vincristine Sulfate Injection.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using DBL Vincristine Sulfate Injection.
Where to find information in this leaflet:
1. Why am I being given DBL Vincristine Sulfate Injection?
DBL Vincristine Sulfate Injection contains the active ingredient vincristine sulfate. Vincristine sulfate belongs to a group of anticancer medicines called Vinca alkaloids.
It is used for the treatment of various cancers. Vincristine stops the cancer cells
growing and eventually kills them.
DBL Vincristine Sulfate Injection is used to treat certain cancers. These cancers include:
acute leukaemia
Hodgkin's disease
non-Hodgkin's disease
rhabdomyosarcoma
neuroblastoma
Wilm's tumour
bone cancer
mycosis fungoides
Ewing's sarcoma
uterine or cervical cancer
breast cancer
malignant melanoma
lung cancer
gynaecological childhood tumours
Your doctor may have prescribed vincristine for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Vincristine is not addictive.
2. What should I know before receiving DBL Vincristine Sulfate Injection?
Warnings
Do not receive DBL Vincristine Sulfate Injection if:
you are allergic to vincristine, or any of the ingredients listed at the end of this
leaflet.
you are allergic to any of the Vinca alkaloids medicines e.g. vinblastine and vindesine.
you suffer from demyelinating Charcot-Marie-Tooth-Syndrome. This is a type of hereditary
nerve disease.
you are receiving or have received radiation therapy to areas that include the liver.
you are pregnant or intend to become pregnant.
you are breast-feeding or plan to breast-feed.
Symptoms of an allergic reaction to vincristine may include:
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.
Always check the ingredients to make sure you can use this medicine.
If you are not sure whether you should be given DBL Vincristine Sulfate Injection,
talk to your doctor or pharmacist.
Check with your doctor if you have or have had any of the following medical conditions:
gout
kidney stones
liver problems or jaundice
any infections, especially chicken pox or shingles
nerve or muscle disease.
Check with your doctor if you take any medicines for any other condition.
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
You must not be given DBL Vincristine Sulfate Injection if you are pregnant or intend
to become pregnant.
Vincristine may affect your developing baby if you are given it during pregnancy.
It is recommended that you and your doctor discuss the need for vincristine treatment
during pregnancy, and the possible risks and benefits of using vincristine during
pregnancy.
Vincristine may cause birth defects if either the male or the female is undergoing
treatment at the time of conception, or if the female is receiving vincristine during
early pregnancy.
Women of childbearing potential should use effective contraception during treatment
with DBL Vincristine Sulfate Injection and for at least 7 months after the last dose.
Male patients being treated with Vincristine Sulfate injection should use effective
contraception during treatment and for at least 4 months after the last dose if their
female partner is of child bearing potential.
Many cancer medicines can cause infertility. Your doctor should discuss this issue
with you before you begin therapy with vincristine.
You should not be given DBL Vincristine Sulfate Injection if you are breast-feeding
or plan to breast-feed.
It is not known whether vincristine passes into breast milk. Do not breastfeed while
being treated with DBL Vincristine Sulfate Injection and for one month after the last
dose.
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 and vincristine may interfere with each other. These include:
other anti-cancer drugs e.g. bleomycin, methotrexate, doxorubicin, asparaginase, cis-platin,
carboplatin and mitomycin-C
medicines used to help fight infection, following chemotherapy e.g. filgrastim and
pegfilgrastim
some medicines used to treat infections e.g. itraconazole, fluconazole, voriconazole,
isoniazid, ciprofloxacin, norfloxacin and ofloxacin
some heart medications e.g. nifedipine or digoxin
medicines to treat gout e.g. allopurinol, colchicine, probenecid or sulfinpyrazone
phenytoin, a medicine to prevent seizures, fits or epilepsy
vaccines
St John's wort.
These medicines may be affected by DBL Vincristine Sulfate Injection, or may affect
how well it works. You may need different amounts of your medicine, or you may need
to take different medicines. Your doctor or pharmacist will advise you.
Vaccinations
Do not have any vaccinations (immunisations) without your doctor's approval while
you are being treated with vincristine, and for up to 12 months after you stop treatment
with it.
Vincristine may lower your body's resistance to infection and there is a chance that
you may get the infection the immunisation is meant to prevent.
In addition, other people living in your household should not take oral polio vaccine
(sabin) since there is a chance they could pass the polio virus on to you.
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 Vincristine Sulfate Injection.
4. How is DBL Vincristine Sulfate Injection given?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight, age, blood tests, how well your liver is working,
and whether or not other medicines are being given at the same time.
When DBL Vincristine Sulfate Injection is given
Vincristine is usually given as a course of injections at weekly intervals.
How it is given
DBL Vincristine Sulfate Injection is given as a slow injection (drip) into a vein.
Vincristine must only be given by a doctor or nurse.
Several courses of vincristine therapy may be needed, depending on your response to
treatment.
Additional treatment should not be repeated until your blood cell numbers return to
acceptable levels and any unwanted effects have been controlled.
If you are given too much DBL Vincristine Sulfate Injection
As DBL Vincristine Sulfate Injection is given to you under the supervision of your
doctor, it is very unlikely that you will receive too much.
However, if you experience any side effects after being given this medicine, tell
your doctor or nurse immediately.
Your doctor or pharmacist has information on how to recognise and treat an overdose.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know while receiving DBL Vincristine Sulfate Injection?
Things you must do
Tell your doctor, nurse or pharmacist if you have any concerns before, during or after
administration of DBL Vincristine Sulfate Injection.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given DBL Vincristine Sulfate Injection.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being given DBL Vincristine Sulfate Injection.
If you plan to be vaccinated within a year of being given DBL Vincristine Sulfate
Injection, tell the doctor before you are vaccinated.
If you or your partner become pregnant while being given or soon after being given
DBL Vincristine Sulfate Injection, tell your doctor or pharmacist.
Reducing the risk of infection or bleeding
DBL Vincristine Sulfate Injection can temporarily lower the number of white blood
cells in your blood, increasing the chance of you getting an infection. It can also
lower the number of platelets, which are necessary for proper blood clotting. If this
occurs, there are certain precautions you can take, especially when your blood count
is low, to reduce the risk of infection or bleeding:
If you can, avoid people with infections. Check with your doctor immediately if you
think you are getting an infection, or if you get a fever or chills, cough or hoarseness,
lower back or side pain, or painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising,
black stools, blood in urine or stools or pinpoint red spots on your skin.
Be careful when using a regular toothbrush, dental floss or toothpick. Your doctor
or nurse may recommend other ways to clean your teeth and gums. Check with your doctor
before having any dental work done.
Do not touch your eyes or the inside of your nose unless you have just washed your
hands and have not touched anything else in the meantime.
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 could occur.
Be sure to keep all of your doctors' appointments so that your progress can be checked.
Protecting others from DBL Vincristine Sulfate Injection and its breakdown products
DBL Vincristine Sulfate Injection and its breakdown products may be excreted in body
fluids and waste, including blood, urine, faeces, vomitus 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:
Flush the toilet twice to dispose of any body fluids and waste.
Wear 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 Vincristine
Sulfate Injection affects you.
DBL Vincristine Sulfate Injection may cause dizziness, tiredness or affect vision
or movement in some people. If you have any of these symptoms, do not drive, operate
machinery or do anything else that could be dangerous.
Looking after your medicine
DBL Vincristine Sulfate Injection will be stored in the pharmacy or on the ward. It
must be kept in a refrigerator, where the temperature stays between 2-8°C.
Getting rid of any unwanted medicine
Your doctor, nurse or pharmacist will dispose of any left-over medicine.
6. Are there any side effects?
Tell your doctor, pharmacist or nurse as soon as possible if you do not feel well
while you are being given DBL Vincristine Sulfate Injection, even if you do not think
the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, vincristine may have unwanted side effects. Some of these side
effects may be prevented or treated by therapy with other medicines. If side effects
do occur, their severity usually depends on the dose of vincristine you receive.
The effects of DBL Vincristine Sulfate Injection may take some time to occur and therefore
some side effects may be delayed. It is possible that the unwanted side effects may
not occur until months after vincristine is given.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effects
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What to do
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Skin-related:
hair loss
unusual perspiration
increase in sunburn
tingling or burning sensation.
Gastrointestinal disorders:
diarrhoea, nausea or vomiting, loss of appetite and weight loss
inflamed gums.
General disorders:
headache
impotence or reduced sexual drive.
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Speak to your doctor if you have any of these side effects and they worry you.
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General disorders:
dizzy or light-headed when getting up from lying or sitting position
loss of feeling, hearing or taste.
Gastrointestinal disorders:
constipation
mouth ulcers.
Musculoskeletal disorders:
muscle wasting
muscle aches
jaw, bone, limb or back pain.
Renal and urinary disorders:
increased frequency, difficulty or pain in passing urine, or incontinence.
Nervous system disorders:
difficulty in walking.
Eye disorders:
eye sight problems: blurred or double vision, temporary blindness.
Psychiatric disorders:
trouble in sleeping, depression, nervousness, hallucinations, confusion and personality
changes.
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Tell your doctor or nurse as soon as possible if you notice any of the following
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Injection site reactions:
Pain or redness at place of injection.
Cardiac disorders:
tightness or pain in the chest, neck, back or arms as well as abnormal heartbeat.
Allergies and respiratory disorders:
itchy rash, high temperature after the injection, swelling of the face, lips, tongue
or throat and/or difficulty in breathing.
Blood disorders:
signs of infection such as fever or chills, cough, hoarseness and sore throat
black, tarry stools; or blood in stools or urine; pinpoint red spots on skin or any
unusual bleeding or bruising.
Gastrointestinal disorders:
abdominal or stomach cramps.
Liver disorders:
abdominal pain or swelling, sudden weight gain
yellowing of the skin and eyes.
Nervous system disorders:
loss of movement or coordination
muscle spasms
fits, seizures or convulsion.
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Call your doctor or nurse straight away if you notice any of these side effects.
These may be serious side effects. You may need urgent medical attention. Serious
side effects are rare.
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Tell your doctor 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.
Treatment with vincristine may cause changes in your blood cells which may be serious.
Vincristine may also affect how your kidneys and liver work. Your doctor will arrange
regular blood tests and checks to detect any changes.
The benefits and side effects of this medicine may take some time to occur. Therefore,
even after you have finished receiving your vincristine 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 or receiving any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Vincristine Sulfate Injection contains
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Active ingredient
(main ingredient)
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Vincristine sulfate
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Other ingredients
(inactive ingredients)
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Mannitol
Water for injections
Sodium hydroxide
Sulfuric acid
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Do not take this medicine if you are allergic to any of these ingredients.
DBL Vincristine Sulfate Injection does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
What DBL Vincristine Sulfate Injection looks like
DBL Vincristine Sulfate Injection is a clear, colourless solution.
DBL Vincristine Sulfate Injection 1 mg/1 mL vial
(AUST R 16308).
DBL Vincristine Sulfate Injection 2 mg/2 mL vial
(AUST R 47249)
Who distributes DBL Vincristine Sulfate Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in November 2025.