Powder for Injection
Bortezomib
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DBL Bortezomib Powder for Injection.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
DBL Bortezomib Powder for Injection against the benefits they expect it will have
for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What DBL Bortezomib Powder for Injection is used for
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)
This medicine belongs to a group of drugs called antineoplastic or cytotoxic medicines.
These medicines are used to kill cancer cells.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
This medicine is not addictive and is available only with a doctor's prescription.
Before you are given DBL Bortezomib Powder for Injection
When you must not be given it
Do not use DBL Bortezomib Powder for Injection if you have an allergy to:
bortezomib, boron or mannitol.
Some of the symptoms of an allergic reaction 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
Tell 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. It is not recommended for use during pregnancy.
Tell 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 breast-feeding 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.
Before you start to use it
Tell your doctor if you have or have had any of the following medical conditions:
blood disorder with a low level of red or white blood cells or platelets. This disorder
may become worse during treatment with DBL Bortezomib Powder for Injection.
if you are suffering from diarrhoea or vomiting as this may become worse during treatment
with DBL Bortezomib Powder for Injection.
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). This effect
may be worsened by treatment with DBL Bortezomib Powder for Injection
seizures
any bleeding problems
problems with your heart
lung or breathing problems
Tell your doctor if you are pregnant or plan to become pregnant.
Tell your doctor if you are trying to make your partner pregnant.
Both men and women receiving DBL Bortezomib Powder for Injection and their partners
must use a reliable method of contraception while receiving DBL Bortezomib Powder
for Injection.
If you have not told your doctor about any of the above, tell him/her before you start
your treatment with DBL Bortezomib Powder for Injection.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get 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 heart beat
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 medicines, or you may need
to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How DBL Bortezomib Powder for Injection is 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 (eg doctor or
nurse) experienced in giving this type of 'oncology' medicine.
How much is given:
Your doctor will decide how much you will receive (the dose). This dose will be calculated
from your height and weight. It will also depend on how other parts of your body are
functioning, such as kidney and liver and what other medicines you are taking.
Your doctor may change the dose during treatment depending on your response.
Ask your doctor or pharmacist if you want to know more about the dose of DBL Bortezomib
Powder for Injection you are receiving.
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.
|
Week/Day
|
One cycle of treatment
|
|
Week 3
(Day 15-21)
|
day 15 to 21 break
|
|
Week 1 (Day 1-7)
|
day 1
|
day 4
|
|
Week 2
(Day 8-14)
|
day 8
|
day 11
|
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 will 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 you receive too much (overdose)
As DBL Bortezomib Powder for 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 DBL Bortezomib Powder
for Injection, tell your doctor or nurse immediately or go to Accident and Emergency
at your nearest hospital.
You may need urgent medical attention.
While you are receiving DBL Bortezomib Powder for Injection
Things you must 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.
Ask your doctor or pharmacist if you have any questions.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are receiving DBL Bortezomib Powder for Injection.
Tell any other doctors, dentists, and pharmacists who treat you that you are receiving
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
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.
Things to be careful of
Be careful driving or operating machinery until you know how DBL Bortezomib Powder
for Injection affects you.
This medicine 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. Make sure you know how you
react to DBL Bortezomib Powder for Injection before you drive a car or operate machinery.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness or light-headedness) may be worse.
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 the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Side effects
Like other medicines that treat cancer, DBL Bortezomib Powder for Injection may have
unwanted side effects, some of which may be serious. You may need medical treatment
if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are receiving DBL Bortezomib Powder for Injection
Below is a list of side effects that you may experience while receiving DBL Bortezomib
Powder for Injection;
tiredness, generally feeling unwell, weakness
feeling sick (nausea) or vomiting
diarrhoea
constipation
loss of appetite, and/or weight, fear of gaining weight
bleeding or bruising more easily than normal
sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands
or feet
fever, chills
anaemia (a condition in which there is a decreased number of red blood cells) e.g.
tiredness, headaches, being short of breath when exercising, dizziness and looking
pale
frequent infections such as fever, severe chills, sore throat or mouth ulcers
herpes virus or hepatitis infections
headache, trouble sleeping, sweating, anxiety, mood swings, confusion or depression
painful, swollen joints
pain in your limbs, back pain, bone pain, muscle cramps
temporary inflammation of the nerves, causing pain, weakness, and paralysis in the
extremities and often progressing to the chest and face
swelling (around the eyes or in the ankles, wrists, arms, legs or face)
pins and needles and unpleasant sensations
difficulty in breathing
dizziness
dehydration
cough
aching muscles, muscle tenderness or weakness not caused by exercise
uncomfortable feeling in the stomach or belching after eating
stomach pain
blockage in the intestine
bad taste in the mouth
low blood pressure (dizziness, light headedness or fainting)
high blood pressure
chest pain
small blisters in clusters on the skin (herpes)
rash, itching
redness of the skin or redness and pain at injection site
hair loss
blurred vision
pneumonia
allergic reaction.
If you think you are having an allergic reaction to DBL Bortezomib Powder for Injection,
tell you doctor immediately or go to Accident and Emergency at your nearest hospital.
Symptoms usually include some or all of the following:
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.
Other side effects not listed above may also occur in some people.
Tell your doctor, nurse or pharmacist if you notice any other effect that is making
you feel unwell.
After using DBL Bortezomib Powder for Injection
Storage
DBL Bortezomib Powder for Injection vials are kept in the outer carton, protected
from light and in a cool dry place below 25 °C and will be stored in the pharmacy
or on the ward.
Product description
What it 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 powder is dissolved in a small
quantity of sterile, sodium chloride solution. The solution for injection is clear
and colourless.
Ingredients
DBL Bortezomib Powder for Injection contains:
bortezomib 1 mg
(for DBL Bortezomib Powder for Injection 1 mg Vials)
OR
bortezomib 2.5 mg
(for DBL Bortezomib Powder for Injection 2.5 mg Vials)
OR
bortezomib 3 mg
(for DBL Bortezomib Powder for Injection 3 mg Vials)
OR
bortezomib 3.5 mg
(for DBL Bortezomib Powder for Injection 3.5 mg Vials) as the active ingredient.
Other ingredients:
mannitol
nitrogen
Supplier
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au
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).
Date of Preparation
This leaflet was prepared in February 2023.
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© Pfizer Australia Pty Ltd