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 given DBL Bortezomib Powder for Injection?
DBL Bortezomib Powder for Injection contains the active ingredient bortezomib. DBL
Bortezomib Powder for Injection is used to treat multiple myeloma (cancer of the bone
marrow) and mantle cell lymphoma (a type of cancer affecting the lymph nodes).
2. What should I know before I am given DBL Bortezomib Powder for Injection?
You will not be given DBL Bortezomib Powder for Injection if you have ever had an
allergic reaction to bortezomib, boron, mannitol 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 Bortezomib Powder for Injection and affect how
it works.
4. How is DBL Bortezomib Powder for Injection given?
Your treatment with DBL Bortezomib Powder for Injection will be done under the supervision
of a doctor. This medicine will be given by a healthcare professional (e.g. doctor
or nurse) experienced in giving this type of 'oncology' medicine.
5. What should I know while being given DBL Bortezomib Powder for 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
DBL Bortezomib Powder for Injection.
If you become pregnant, while taking this medicine, tell your doctor immediately.
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Things to be careful of
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If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
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Driving or using machines
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Be careful driving or operating machinery until you know how this medicine affects
you. If you have symptoms of dizziness, light-headedness, tiredness, fainting, doubled
or blurred vision do not drive, operate machinery, or do anything else that could
be dangerous.
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Drinking alcohol
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Be careful when drinking alcohol while you are being treated with this medicine, as
dizziness or light-headedness may be worse.
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6. Are there any side effects?
Side effects include anaemia e.g. tiredness, weakness, headaches, dizziness, looking
pale, nausea, vomiting, diarrhoea, constipation, loss of appetite and/or weight, fear
of gaining weight, bleeding or bruising, sensitivity, numbness, tingling or burning
sensation of the skin, fever, chills, sore throat, mouth ulcers, herpes virus or hepatitis
infections, trouble sleeping, anxiety, confusion, depression, painful, swollen joints,
pain in the limbs, back pain, bone pain, muscle cramps, temporary inflammation of
the nerves, dehydration, cough, stomach pain, blockage in the intestine, bad taste
in the mouth, low/high blood pressure, chest pain, hair loss, blurred vision, pneumonia,
rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing,
swelling of the face, lips, tongue or other parts of the body. 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):
bortezomib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Bortezomib Powder for
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 Bortezomib Powder for Injection.
Where to find information in this leaflet:
1. Why am I being given DBL Bortezomib Powder for Injection?
DBL Bortezomib Powder for Injection contains the active ingredient bortezomib. It belongs to a group of drugs called antineoplastic or cytotoxic medicines. These
medicines are used to kill cancer cells.
DBL Bortezomib Powder for Injection is used to treat:
multiple myeloma (cancer of the bone marrow)
mantle cell lymphoma (a type of cancer affecting the lymph nodes).
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
There is no evidence that bortezomib is addictive.
This medicine is available only with a doctor's prescription.
2. What should I know before I am given DBL Bortezomib Powder for Injection?
Warnings
You should not be given DBL Bortezomib Powder for Injection if:
you are allergic to bortezomib, boron or mannitol or any of the ingredients listed
at the end of this leaflet.
Tell your doctor if you have or have had any medical conditions, especially the following:
blood disorder with a low level of red or white blood cells or platelets
diarrhoea or vomiting
a history of fainting, dizziness or light-headedness
kidney problems
liver problems including hepatitis infection
problems with numbness, tingling or pain in the hands or feet (neuropathy)
seizures
any bleeding problems
problems with your heart
lung or breathing problems
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
Check with your doctor if you are pregnant or intend to become pregnant.
It may affect your developing baby if you use DBL Bortezomib Powder for Injection
during pregnancy. This medicine is not recommended for use during pregnancy.
Both men and women receiving DBL Bortezomib Powder for Injection and their partners
must use a reliable method of contraception.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether DBL Bortezomib Powder for Injection passes into breast milk.
Therefore, there is a possibility that your baby may be affected.
If you wish to restart breastfeeding after your DBL Bortezomib Powder for Injection
treatment, you must discuss this with your doctor or nurse, who will tell you when
it is safe to do so.
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 DBL Bortezomib Powder for injection may interfere with each other.
These include:
amiodarone, a medicine used to treat irregular heartbeat
medicines used to treat viral infections such as flu, herpes and HIV
isoniazid, a medicine used to treat tuberculosis
nitrofurantoin, a medicine used to treat urinary tract infections
ketoconazole, a medicine used to treat fungal infections
ritonavir, a medicine used to treat HIV infection
rifampicin, a medicine used to treat infections such as tuberculosis
medicines used to treat high cholesterol levels in the blood
medicines used to treat diabetes
medicines that may lower blood pressure
medicine used to treat epilepsy such as carbamazepine and phenobarbital
phenytoin, a medicine used in preventing seizures
St John's Wort (Hypericum perforatum).
These medicines may be affected by DBL Bortezomib Powder for 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.
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 Bortezomib Powder for Injection.
4. How is DBL Bortezomib Powder for Injection given?
Your treatment with DBL Bortezomib Powder for Injection will be done under the supervision
of a doctor. This medicine will be given by a healthcare professional (e.g. doctor
or nurse) experienced in giving this type of 'oncology' medicine.
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.
How it is given
DBL Bortezomib Powder for Injection will be dissolved in a sterile solution for injection.
The solution is given as an injection into your vein (intravenously) over 3 to 5 seconds.
The solution can also be given subcutaneously as an injection into your thighs or
stomach.
When it is given
Multiple Myeloma
One cycle of treatment with DBL Bortezomib Powder for Injection may consist of a total
of 4 doses given over 3 weeks. Doses are given on days 1, 4, 8 and 11 followed by
a ten day break from the treatment.
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Week/Day
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One cycle of treatment
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Week 1
(Day 1-7)
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day 1
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day 4
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Week 2
(Day 8-14)
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day 8
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day 11
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Week 3
(Day 15-21)
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day 15 to 21 break
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Note day 1 is the first dose you will receive your DBL Bortezomib Powder for Injection
in a treatment cycle. Subsequent doses for the same treatment cycle will be counted
from day 1, e.g. your 3rd dose with be the 8th day (day 8).
When DBL Bortezomib Powder for Injection is given with thalidomide and dexamethasone,
the treatment consists of a total of 3 cycles (9 weeks) for the induction stage.
During the induction stage, DBL Bortezomib Powder for Injection is administered twice
weekly (days 1, 4, 8 and 11).
When DBL Bortezomib Powder for Injection is given with dexamethasone; the treatment
consists of a total of 4 cycles (12 weeks). DBL Bortezomib Powder for Injection will
be administered twice weekly (days 1, 4, 8 and 11).
When DBL Bortezomib Powder for Injection is given with melphalan and prednisone, one
cycle of treatment is 6 weeks and the treatment consists of a total of 9 cycles (54
weeks). In Cycles 1-4, DBL Bortezomib Powder for Injection is administered twice weekly
(days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, DBL Bortezomib Powder for Injection
is administered once weekly (days 1, 8, 22 and 29).
Mantle Cell Lymphoma
When DBL Bortezomib Powder for Injection is given with rituximab, cyclophosphamide,
doxorubicin and prednisone, one cycle is 3 weeks and the treatment consists of a total
of up to 8 cycles (24 weeks). For each cycle, DBL Bortezomib Powder for Injection
is given on days 1, 4, 8 and 11, followed by a ten day break from the treatment.
Your doctor will decide on the number of cycles of DBL Bortezomib Powder for Injection
needed. This will depend on how you respond to treatment.
If too much DBL Bortezomib Powder for Injection is given
DBL Bortezomib Powder for Injection is given in a hospital or clinic under the supervision
of a doctor, it is very unlikely that you will be given too much of the medicine.
Your doctor or nurse will be monitoring your progress and checking the medicine that
you are given.
If you think that you have been given too much DBL Bortezomib Powder for Injection,
you may need urgent medical attention.
5. What should I know while being given DBL Bortezomib Powder for Injection?
Things you should do
It is important to receive your doses of DBL Bortezomib Powder for Injection at the
appropriate times according to your treatment cycle to get the best effects from your
treatment. This will be explained to you by your doctor or nurse.
Please ensure that you follow your doctor's instructions about other medicines you
should take, and other things you should do.
You may need to take other medicines to help prevent unwanted effects of DBL Bortezomib
Powder for Injection. You may also need to drink extra fluids if you experience vomiting
and/or diarrhoea.
Remind any doctor, dentist, nurse or pharmacist you visit that you are using DBL Bortezomib
Powder for Injection.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine as it may affect the other medicines used during surgery.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests (such as blood or urine) from time to time to make sure
the medicine is working and to prevent unwanted side effects.
DBL Bortezomib Powder 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 have infections. Check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain or find it's painful or difficult to urinate.
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with
your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail cutters.
Avoid contact sports or other situations where you may bruise or get injured.
Call your doctor straight away if you:
Become pregnant while taking this medicine.
Things to be careful of
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Bortezomib
Powder for Injection affects you.
DBL Bortezomib Powder for Injection may cause dizziness, light-headedness, tiredness,
fainting, double or blurred vision 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
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness or light-headedness may be worse.
Getting out of bed or standing up
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
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.
Common side effects
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Common side effects
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What to do
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General Disorders and administration site conditions:
chest pain
redness of the skin or redness and pain at injection site
Gastrointestinal System Disorders:
feeling sick (nausea) or vomiting
diarrhoea
constipation
uncomfortable feeling in the stomach, burping after eating or having hiccups
stomach pain
ulcers in the mouth or dry mouth
throat pain
Psychiatric disorders:
trouble sleeping
anxiety
confusion
depression
Musculoskeletal and connective tissue disorders:
aching muscles, muscle tenderness or weakness not caused by exercise
painful, swollen joints
pain in your limbs, bone pain, muscle cramps
sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands
or feet
Ear and labyrinth disorders:
dizziness
Nervous system disorders:
headache
pins and needles and unpleasant sensations
bad taste in the mouth
Metabolism and nutritional disorders:
loss of appetite, and/or weight, fear of gaining weight
dehydration
Respiratory, thoracic and mediastinal disorders:
cough
blood nose or runny nose
Vascular Disorders:
low blood pressure (dizziness, lightheadedness or fainting)
high blood pressure
Eye Disorders:
blurred vision
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Speak to your doctor if you have any of these common side effects and they worry you.
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Serious side effects
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Serious side effects
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What to do
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General Disorders and administration site conditions:
tiredness, generally feeling unwell, weakness
fever, chills, shivering
Infections and Infestations:
herpes virus or hepatitis infections
small blisters in clusters on the skin (herpes)
pneumonia
Blood and lymphatic system disorders:
thrombocytopenia, anaemia or neutropenia (conditions in which there are decreased
numbers of platelets, red blood cells or white blood cells in your blood). These side
effects can cause tiredness, headaches, being short of breath when exercising, dizziness,
looking pale, bruising easily or unusual bleeding including in your poo or wee.
Nervous system disorders:
temporary inflammation of the nerves, causing pain, weakness, and paralysis in the
extremities and often progressing to the chest and face
Musculoskeletal and connective tissue disorders:
back pain
Allergic Reaction:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing, swelling of the face, lips,
tongue or other parts of the body.
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Call your doctor straight away 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.
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 Bortezomib Powder for Injection contains
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Active ingredient
(main ingredient)
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bortezomib
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Other ingredients
(inactive ingredients)
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mannitol
nitrogen
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Do not take this medicine if you are allergic to any of these ingredients.
DBL Bortezomib Powder for Injection does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
What DBL Bortezomib Powder for Injection looks like
DBL Bortezomib Powder for Injection is a white to off-white powder in a clear glass
vial.
Each pack contains one single-use vial.
Before injection, DBL Bortezomib Powder for Injection is dissolved in a small quantity
of sterile, sodium chloride solution. The solution for injection is clear and colourless.
Australian Registration Numbers
DBL Bortezomib Powder for Injection 1 mg vial - AUST R 313359
DBL Bortezomib Powder for Injection 2.5 mg vial - AUST R 275710
DBL Bortezomib Powder for Injection 3 mg vial - AUST R 275706
DBL Bortezomib Powder for Injection 3.5 mg vial - AUST R 275708
Who distributes DBL Bortezomib Powder for Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in June 2025.
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