Powder for Injection
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What VELCADE is used for
VELCADE belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called
chemotherapy medicines. These medicines are used to kill cancer cells.
VELCADE is used to treat adults with multiple myeloma (cancer of the bone marrow). It is prescribed for patients who have
not been previously treated for multiple myeloma. It is also prescribed for patients who have received one or more prior treatments
and whose cancer is still progressing.
Your doctor may have prescribed VELCADE for another reason.
Ask your doctor if you have any questions about why VELCADE has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you are given VELCADE
When you must not use it:
Do not use VELCADE if:
you know you are allergic (hypersensitive) to bortezomib or boron or mannitol.
Symptoms of an allergic reaction may include 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.
Before you start to use it:
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. This disorder may become worse during treatment
if you are suffering from diarrhoea or vomiting as this may become worse during treatment with VELCADE.
a history of fainting, dizziness or light-headedness.
problems with numbness, tingling or pain in the hands or feet (neuropathy). This effect may be worsened by treatment with
any bleeding problems
problems with your heart
lung or breathing problems
Tell your doctor if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, VELCADE is not recommended for use during pregnancy.
Tell your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether VELCADE passes into breast milk. Therefore there is a possibility that the breast-fed baby may be
If you wish to restart breast-feeding after your VELCADE treatment, you must discuss this with your doctor or nurse, who will
tell you when it is safe to do so.
Tell your doctor if you are trying to make your partner pregnant.
Both men and women receiving VELCADE and their partners must use a reliable method of contraception during and for 3 months
after receiving VELCADE.
If you have not told your doctor about any of the above, tell them before you start treatment with VELCADE.
Taking other medicines:
Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy,
supermarket or health food shop.
In particular, tell your doctor if you are taking any of the following:
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
medicines used to treat high cholesterol levels in the blood
medicines used to treat diabetes
medicines that may lower blood pressure
rifampicin, an antibiotic used with other medicine to treat tuberculosis.
medicine used to treat epilepsy such as carbamazepine and phenobarbital
phenytoin, a medicine used in preventing seizures.
These medicines may be affected by VELCADE or may affect how well VELCADE works. Your doctor or pharmacist can tell you what
to do if you are using any of these medicines.
How VELCADE is given
Your treatment with VELCADE will take place in a specialised medical unit, under the supervision of a doctor experienced in
the use of cytotoxic medicinal products.
How much is given:
Your doctor will decide what dose you will receive. The dose will be calculated from your height and weight. It will also
depend on factors such as kidney function, liver function and other medicines you are being given.
The safety of treatment with VELCADE in people with severe kidney function problems had not been well-studied.
The usual starting dose is 1.3 milligrams per square meter body surface area.
Your doctor may change the dose during treatment depending on your response.
Ask your doctor if you want to know more about the dose of VELCADE you receive.
How it is given:
VELCADE will be dissolved in sterile normal sodium chloride (salt) solution for injection. The solution is given as an injection
into your vein (intravenously) over 3 to 5 seconds. The injection tube will be rinsed with a small quantity of sterile normal
sodium chloride (salt) solution.
The solution can also be given subcutaneously as an injection into your thighs (right or left), or abdomen (right or left).
When it is given:
One cycle of treatment with VELCADE consists 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.
When VELCADE is given with melphalan and prednisone, the treatment consists of a total of 9 cycles (54 weeks). In Cycles
1-4, VELCADE is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, VELCADE is administered once
weekly (days (1, 8, 22 and 29).
When VELCADE is given with thalidomide and dexamethasone, the treatment consists of a total of 3 cycles (9 weeks) for the
induction stage and 2 cycles (10 weeks) for the consolidation stage. During the induction stage, VELCADE is administered twice
weekly (days 1, 4, 8 and 11). During the consolidation stage, VELCADE is administered once weekly (days 1, 8, 15 and 22).
When VELCADE is given with dexamethasone, the treatment consists of a total of 4 cycles (12 weeks). VELCADE will be administered
twice weekly (days 1, 4, 8 and 11).
Your doctor will decide on the number of cycles of VELCADE needed. This will depend on how you respond to treatment.
What do I do if I receive too much? (overdose):
As VELCADE 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 VELCADE, tell you doctor or nurse immediately or go to Accident and
Emergency at your nearest hospital.
You may need urgent medical attention.
While you are using VELCADE
Things you must do:
Be sure to keep all your doctor's appointments so your progress can be checked.
Your doctor will want to do some blood, urine and other tests from time to time to check on your progress and detect any unwanted
Keep follow up appointments with your doctor.
It is important to have your follow-up doses of VELCADE at the appropriate times to get the best effects from your treatment.
Be sure to follow up 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 VELCADE. 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.
Tell any other doctors, dentists and pharmacists who are treating you that you are having VELCADE.
If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are having VELCADE.
If you plan to have surgery, tell your doctor or dentist that you are having VELCADE.
If you become pregnant or your partner becomes pregnant while being given VELCADE, tell your doctor immediately.
VELCADE 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.
Things to be careful of
Be careful driving or operating machinery until you know how VELCADE affects you.
VELCADE may cause tiredness, light-headedness, dizziness, fainting, double or blurred vision in some people. Make sure you
know how you react to VELCADE before you drive a car, operate machinery, or do anything else that could be dangerous if you
are dizzy, light headed or have double or blurred vision. If you drink alcohol, dizziness or light-headedness may be worse.
You may feel dizzy or faint when you get up quickly after sitting or lying down.
Getting up slowly may help.
Like all medicines, VELCADE can have side effects. Some of these effects may be serious. However there may be ways to reduce
the discomfort of these effects. You may need medical treatment if you get some of the side effects.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being treated with VELCADE.
Below is a list of the more common side effects you could get while being treated with VELCADE:
tiredness, generally feeling unwell, weakness
feeling sick (nausea) or vomiting
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
anaemia (a condition in which there is a decreased number of red blood cells)
frequent infections such as fever, severe chills, sore throat or mouth ulcers
trouble sleeping, sweating, anxiety, mood swings, confusion or depression
painful, swollen joints
pain in your limbs, back pain, bone pain, muscle cramps
swelling (around the eyes or in the ankles, wrists, arms, legs or face)
pins and needles and unpleasant sensations
difficulty in breathing
aching muscles, muscle tenderness or weakness not caused by exercise
uncomfortable feeling in the stomach or belching after eating
bad taste in the mouth
low blood pressure (dizziness, light headedness or fainting)
small blisters in clusters on the skin (herpes)
redness of the skin or redness and pain at injection site
If you think you are having an allergic reaction to VELCADE, 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.
VELCADE should be kept in a cool dry place, protected from light, where the temperature stays below 25°C.
What it looks like:
VELCADE is a white to off-white powder in a glass vial.
Each pack contains one single-use vial.
Before injection, VELCADE powder is dissolved in a small quantity of sterile, sodium chloride solution. The solution for injection
is clear and colourless.
VELCADE 3.5mg vial (AUST R 104542)
VELCADE 1mg vial (AUST R 148329).
(for VELCADE 3.5mg Vials) OR
(for VELCADE 1.0mg Vials)
mannitol (E 421)
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: (02) 8875 3333 or Toll Free 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: (09) 523 8700 or 0800 800 806
This leaflet was prepared in October 2012.