ImmuCyst®
(im-you-sist)
BCG immunotherapeutic (BCG im-you-no-thera-pew-tick)
Consumer Medicine Information (CMI)
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Immucyst. It does not contain all the information that is known about Immucyst. 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 ImmuCyst is used for
ImmuCyst is used to treat some types of cancer that occur on the inside surface of the urinary bladder.
The exact way that ImmuCyst works is still not completely known. When instilled into the bladder, ImmuCyst causes an immune reaction in the bladder which causes the body's own cells to help destroy any remaining cancer cells. As with any cancer treatment, ImmuCyst may not be effective in all patients and may not cure your cancer forever.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor's prescription.
This medicine is not addictive.
Before you are given it
When you must not be given it
Do not receive ImmuCyst if you have:
tuberculosis
current or history of severe reaction to BCG
fever
infection of your urinary tract or bladder
blood in your urine
a weak immune system or are taking drugs that weaken your immune system
had an operation on your bladder within the past 7 to 14 days
Do not receive ImmuCyst if you are allergic to it or any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not give ImmuCyst to a child or adolescent.
There is no experience with its use in children or adolescents under 18 years old.
Do not receive it if you are pregnant or intend to become pregnant.
It is not known whether ImmuCyst can affect your developing baby if you are given it during pregnancy.
Do not receive it if you are breastfeeding or planning to breastfeed.
It is not known if ImmuCyst passes into breast milk and there is a possibility your baby may be affected.
Do not receive it after the expiry date (EXP) printed on the carton.
If you receive it after the expiry date has passed, it may not work as well.
Do not receive it if the packaging is damaged or shows signs of tampering.
Before you are given it
Tell your doctor if you have allergies to:
any of the ingredients listed at the end of this leaflet
latex
any other substances, such as foods, preservatives or dyes
Tell your doctor if you are pregnant or intend to become pregnant.
Like most medicines of this kind, ImmuCyst is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of being given it if you are pregnant.
Tell your doctor if you are breastfeeding or planning to breastfeed.
It is not known whether ImmuCyst passes into breast milk. Your doctor will discuss the risks and benefits of being given it if you are breastfeeding or planning to breastfeed.
Tell your doctor if you have or have had any medical conditions, especially the following:
tuberculosis or a cough
an illness with a fever
an operation to remove a bladder tumour within the past 7 days
infection of your urinary tract or bladder
a weak immune system
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell them before you are given ImmuCyst.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.
Some medicines may interfere with the effect of ImmuCyst. These include:
medicines that weaken your immune system
medicines used to treat bacterial infections (antibiotics)
medicines used to treat tuberculosis
These medicines may be affected by ImmuCyst, or may affect how well it works. ImmuCyst should not be mixed with other medicines.
How it is given
ImmuCyst should only be administered by trained professionals, with appropriate handling, in a hospital or clinic environment.
How much to be given
Your doctor will decide what dose of ImmuCyst you will receive.
Ask your doctor if you want to know more about the dose of ImmuCyst you receive.
How it is given
When prepared following recommended instructions, one ImmuCyst treatment is a 53 mL liquid solution. To administer ImmuCyst, your doctor or nurse will insert a tube (a catheter) into your bladder and drain any urine. After the bladder is emptied, the ImmuCyst solution will be slowly run into your bladder via gravity.
You must then lie on your sides for 15 minutes each. You will be allowed up for the next hour. At the end of 2 hours, or sooner if you cannot hold the ImmuCyst in your bladder any longer, the ImmuCyst in your bladder can be passed like urine. You may pass the urine using the rubber catheter tube, or if you use the toilet, you must be in a seated position.
How long it will be given
ImmuCyst is usually given once a week for 6 weeks. Your doctor will discuss with you whether further doses will be necessary. Some people are given further ImmuCyst treatments over a 2 year period, to help prevent recurrence of disease.
If you receive too much (overdose)
As ImmuCyst 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 ImmuCyst, 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 being given it
Things you must do
Tell all the doctors, dentists and pharmacists who are treating you that you are being given ImmuCyst.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given ImmuCyst.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given this medicine.
If you become pregnant while you are being given this medicine, tell your doctor immediately.
Things you must not do
Do not receive this medicine to treat any other complaints.
Things to be careful of
It is important that for 6 hours following your ImmuCyst treatment, you go to the toilet in a seated position.
This is because ImmuCyst is prepared from bacteria and is still able to cause infection in some people.
Any urine you pass in these 6 hours must be disinfected with bleach (such as 'White King').
This can be done by adding an equal amount of bleach to the urine and leaving it for 15 minutes in the toilet bowl before flushing.
Be careful driving or operating machinery until you know how ImmuCyst affects you.
There have been no studies on the effects of ImmuCyst on the ability to drive or operate machines.
Side effects
All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor as soon as possible if you do not feel well while you are being given ImmuCyst.
It helps most people with bladder cancer, but it may have unwanted side effects in a few people.
Tell your doctor if you have any of the following for longer than 48 hours after treatment, or they increase in severity:
pain or burning when passing urine
fever, chills or tiredness
cough and flu-like symptoms
Tell your doctor immediately if you notice any of the following:
blood in the urine or a need to urinate frequently
joint pain
pain, irritation or redness of the eyes
cough
skin rash
feeling of nausea and vomiting
diarrhoea or loss of appetite
genital pain or swelling of the male sex organs
If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing.
hives
fainting
yellowing of the skin and eyes (jaundice)
These are very serious side effects. If you have them, you may have had a serious allergic reaction to ImmuCyst. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some consumers.
Ask your doctor to answer any questions you may have.
After being given it
If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor.
Storage
ImmuCyst must be stored at 2°C - 8°C.
The best place is in the bottom of your refrigerator. ImmuCyst will be damaged and will not work if it gets too warm, is put into your freezer or is exposed to light.
ImmuCyst must stay sealed in its original pack until your doctor or nurse is ready to prepare it for use. It must not be opened in the sunlight.
Disposal
If your doctor tells you to stop using ImmuCyst, or the medicine has passed its expiry date, return any unused medicine to your pharmacist.
Product description
What it looks like
One ImmuCyst pack contains one vial.
Ingredients
Active Ingredient:
Each dose (one vial) of ImmuCyst contains between 1.8 - 19.2 x 100 000 000 bacteria of the Connaught strain of Bacillus of Calmette and Guerin (BCG).
Inactive Ingredients:
ImmuCyst also contains monosodium glutamate (MSG).
Manufacturer/Sponsor
ImmuCyst is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
ImmuCyst is supplied in New Zealand by:
sanofi-aventis new zealand limited
Level 8, James and Wells Tower
56 Cawley Street
Ellerslie
Auckland
This leaflet was prepared in February 2010.
Australian Register Number
AUST R 168005
® Registered Trademark