Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being treated with this
medicine, speak to your doctor or pharmacist.
1. Why am I being treated with DBL Gemcitabine Injection?
DBL Gemcitabine Injection contains the active ingredient gemcitabine hydrochloride.
DBL Gemcitabine Injection is used to treat the following cancers: lung cancer, pancreatic
cancer, bladder cancer, breast cancer and ovarian cancer.
2. What should I know before being treated with DBL Gemcitabine Injection?
You will not be given DBL Gemcitabine Injection if you have ever had an allergic reaction
to DBL Gemcitabine Injection or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
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 Gemcitabine Injection and affect how it works.
4. How will I be given DBL Gemcitabine Injection?
DBL Gemcitabine Injection will be given to you by a doctor or a nurse, by infusion
into a vein.
5. What should I know while being treated with DBL Gemcitabine Injection?
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Things you should do
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Remind any doctor, nurse, pharmacist and dentist who are treating you that you are
being given this medicine.
If you become pregnant while you are being given DBL Gemcitabine Injection, tell your
doctor immediately. Effective contraception should be used.
Keep all of your doctor’s appointments so your progress can be checked.
Make sure you have all the blood tests asked by your doctor to check your blood cell
count, general condition, kidney and liver function as you are at an increased risk
of getting an infection during treatment.
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Things you should not do
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Do not breastfeed while you are being treated with DBL Gemcitabine Injection.
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Driving or using machines
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Do not drive or operate machinery until you know how DBL Gemcitabine Injection affects
you. This medicine may affect your ability to drive or operate machinery as it can
cause sleepiness or drowsiness in some people.
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6. Are there any side effects?
Side effects may include nausea, vomiting, diarrhoea, constipation, difficulty breathing,
shortness of breath, skin rash, suburn, redness, swelling, itching, swelling of ankles,
hands, feet, face, flu like symptoms including fever, chills, headache, weakness,
loss of appetite, back and/or muscle pain, cough, runny or blocked nose, sneezing,
sweating, generally feeling unwell, fatigue, sleepiness, drowsiness, difficulty sleeping,
unusual hair loss or thinning, soreness, swelling or ulcers in the mouth, scaling,
ulceration or sore formation on the skin.
Active ingredient(s): gemcitabine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being treated with DBL Gemcitabine
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 being treated with DBL Gemcitabine
Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Gemcitabine Injection?
DBL Gemcitabine Injection contains the active ingredient gemcitabine hydrochloride. DBL Gemcitabine Injection belongs to a group of medicines called antineoplastic or
cytotoxic medicines. You may also hear of these being called chemotherapy medicines.
This medicine works by killing cancer cells and stopping cancer cells from growing
and multiplying.
DBL Gemcitabine Injection is used to treat the following cancers: lung cancer, pancreatic
cancer, bladder cancer, breast cancer and ovarian cancer.
2. What should I know before I am treated with DBL Gemcitabine Injection?
Warnings
DBL Gemcitabine Injection should not be given if:
1. you are allergic to gemcitabine, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you have any:
liver problems.
kidney problems.
bone marrow/blood disorder with low numbers of red blood cells, white blood cells,
or platelets.
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 gemcitabine if you are pregnant or intend to become pregnant.
Gemcitabine may cause birth defects. It is recommended that effective contraception
be used.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not breastfeed while you are being treated with gemcitabine.
It is not known whether gemcitabine passes into breast milk.
Use in children
The safety and effectiveness of this medicine in children has not been established.
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/treatments may interfere with DBL Gemcitabine Injection and affect
how it works.
other medicines used to treat cancer (such as oxaliplatin, bevacizumab or cisplatin).
radiation therapy.
certain vaccines (live vaccines such as yellow fever).
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 Gemcitabine Injection.
4. How will I be given DBL Gemcitabine Injection?
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
Several courses of gemcitabine 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 Gemcitabine Injection may be given alone or in combination with other drugs.
DBL Gemcitabine Injection is given as an infusion (a slow injection via a drip) into
a vein. The infusion will last approximately 30 minutes.
DBL Gemcitabine Injection must only be given by a doctor or nurse.
If too much DBL Gemcitabine Injection is given
As DBL Gemcitabine 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 Gemcitabine Injection or experience
severe side effects, you may need urgent medical attention.
Symptoms of an overdose may include the side effects listed in section 6, but are
usually of a more severe nature affecting your blood, stomach, liver or kidneys.
You should immediately:
alert the doctor or nurse in the treatment centre
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 while being treated with DBL Gemcitabine 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 Gemcitabine 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 become pregnant while you are being given gemcitabine, tell your doctor immediately.
Keep all of your doctor’s appointments so your progress can be checked.
Before each dose of gemcitabine, your doctor will do a blood test to check you have
enough blood cells to receive this medicine.
Your doctor will also do blood tests to check your kidney and liver function from
time to time while being treated with DBL Gemcitabine Injection.
Things you should not do
You should not breastfeed while you are being treated with gemcitabine.
Things to be careful of
Gemcitabine 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 gemcitabine 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 Gemcitabine
Injection affects you.
DBL Gemcitabine Injection may cause sleepiness or drowsiness in some people. If you
have any of these symptoms, do not drive, operate machinery or do anything else that
could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
No information is available.
Looking after your medicine
DBL Gemcitabine Injection will be stored appropriately under refrigeration in the
pharmacy or on the hospital ward.
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.
Side effects
Serious side effects
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Serious side effects
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What to do
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sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips or tongue or other parts of the body, shortness of breath, wheezing or
trouble breathing
fever, with other signs of infection such as feeling unwell, shivers, shakes, sore
throat or ulcers
difficulty in breathing, fast shallow breathing, wheezing, discolouration in skin
or nails, fast heart rate, tiredness, cough, chest pain
fever, bruising or bleeding more easily than normal, yellowing of the skin and/or
eyes, passing less urine than is normal, swollen legs
headache with changes in vision, confusion, seizures or fits
severe rash with itching, blistering, peeling of the skin with widespread skin pain
often with fever
severe chest pain, pain or discomfort in the arm, back or neck (usually on the left
side), changes in the rhythm or rate of the heart beat
sudden swelling of the body, rapid drop in blood pressure, lightheadedness and weakness,
nausea, abdominal pain, increased thirst or sudden weight gain
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects
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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.
Some of these side effects (for example, changes in blood cell count, kidney and liver
function) can only be found when your doctor does tests from time to time to check
your progress.
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.
What DBL Gemcitabine Injection contains
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Active ingredient
(main ingredient)
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gemcitabine hydrochloride
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Other ingredients
(inactive ingredients)
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hydrochloric acid
sodium hydroxide
water for Injections
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You should not be given this medicine if you are allergic to any of these ingredients.
What DBL Gemcitabine Injection looks like
DBL Gemcitabine Injection is a clear, colourless to light straw-coloured solution
supplied in a clear glass vial. It is available in single packs of 1 vial.
DBL Gemcitabine Injection is available in the following strengths:
1 g/ 26.3 mL AUST R 160202
2 g/ 52.6 mL AUST R 160204
Who distributes DBL Gemcitabine Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in May 2024.