2. What should I know before I use OncoTICE?
Do not use if you have ever had an allergic reaction to OncoTICE or any of the ingredients
listed at the end of the CMI.
Talk to your healthcare provider 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 OncoTICE and affect how it works.
4. How am I given OncoTICE?
OncoTICE will be instilled into the bladder via a sterile tube (catheter) by a healthcare
provider.
Your healthcare provider will decide on the duration and frequency of treatment for
you.
5. What should I know while using OncoTICE?
|
Things you should do
|
Remind any healthcare provider you visit that you are using OncoTICE.
Refrain from drinking any fluid in the four hours before receiving this product and
during the two hours the OncoTICE remains in the bladder.
It is important you move around while OncoTICE is in the bladder. The solution must
remain in the bladder for two hours and you should not empty your bladder during this
period. After two hours the bladder should be emptied in a sitting position. For six
hours after treatment the bladder should continue to be emptied in a sitting position.
Two cups of household bleach should be added to the toilet containing the urine and
left to stand for 15 minutes before flushing.
|
6. Are there any side effects?
Like all medicines, OncoTICE can cause side effects, although not everybody gets them.
Your healthcare provider will discuss these with you and will explain the risks and
benefits of your treatment. When you get OncoTICE, you can have some serious side
effects
Active ingredient: Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using OncoTICE. You should also speak to your healthcare provider if you would like further information
or if you have any concerns or questions about using OncoTICE.
Where to find information in this leaflet:
1. Why am I using OncoTICE?
OncoTICE contains the active ingredient Mycobacterium bovis (Bacillus Calmette and
Guerin (BCG) strain).
OncoTICE belongs to the group of medicines called immunostimulants. These medicines
stimulate certain parts of the immune system.
OncoTICE is used for the treatment of superficial bladder cancer by stimulating the
body's natural ability to fight disease. It is also used to prevent the disease from
recurring after bladder surgery.
2. What should I know before I use OncoTICE?
Warnings
Do not use OncoTICE if:
you are allergic to Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain),
or any of the ingredients listed at the end of this leaflet. Always check the ingredients
to make sure you can use this medicine.
you have a urinary tract infection. If you have cystitis (inflammation of the bladder),
you will receive a course of antibiotics before treatment with OncoTICE starts. The
treatment with antibiotics needs to be finished before treatment with OncoTICE starts.
you have blood in your urine
you have active tuberculosis - your healthcare provider will probably do a skin reaction
test (Mantoux) to assist in making this diagnosis.
you are being treated with anti-tuberculosis medicines.
you suffer from an impaired immune system (reduced immunity against infectious diseases),
irrespective of the cause.
you are HIV-positive
you are pregnant or are breast feeding your baby
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 healthcare provider if you are pregnant or intend to become pregnant.
Talk to your healthcare provider if you are breastfeeding or intend to breastfeed.
Special Instructions
Take special care with OncoTICE in the following situations:
Before the first time OncoTICE is instilled in your bladder, your healthcare provider
will probably perform a skin reaction test (Mantoux) to investigate if you have an
active tuberculosis infection. If a skin test (Mantoux test) is performed after treatment
with OncoTICE, it may be positive.
If the bladder wall or urethra is damaged during catheterisation, treatment will need
to be postponed until the lesion is healed.
It is important that infection with the HIV virus is excluded. It may be necessary
that a blood sample is taken to test for HIV. Your healthcare provider may also ask
if there are any risk factors, such as unsafe sex, use of shared needles if you use
intravenous drugs, or received blood transfusions.
To protect your partner from transmission of the BCG bacteria, it is advisable to
refrain from sexual intercourse during the week following treatment with OncoTICE.
The use of a condom may protect your partner provided it is used correctly and does
not tear.
3. What if I am taking other medicines?
Tell your healthcare provider 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 may interfere with OncoTICE and affect how it works.
Medicines that may
reduce
the effect of OncoTICE include:
Antibiotics
Medicines that suppress the immune system (immune suppressants) such as anticancer
drugs
Medicines that suppress the production of bone marrow cells (bone marrow suppressants)
Radiation therapy
If you are using any of these medicines or undergoing one of these therapies, your
healthcare provider will postpone treatment with OncoTICE.
Check with your healthcare provider if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect OncoTICE.
4. How do I use OncoTICE?
How OncoTICE is used
OncoTICE will be introduced into the bladder by a healthcare provider.
The contents of one vial will be dissolved in 50mL of saline solution. A sterile tube
(catheter) will be inserted into the bladder through the normal urine passage and
the bladder will be emptied of urine. The OncoTICE solution will be instilled into
the bladder via the tube.
For cancer of the bladder, 7 to 14 days should elapse before BCG is administered following
biopsy or traumatic catheterisation. The treatment schedule comprises a weekly instillation
for the first 6 weeks, followed by a monthly treatment for a period of 12 months.
If you have had bladder surgery, your healthcare provider will start using OncoTICE
between 10 and 15 days later. It will generally be given once a week for 6 weeks,
then an instillation in the 8th and 12th week followed by monthly instillations from
month 4 through to month 12.
Your healthcare provider will decide on the duration and frequency of treatment for
you.
If you are given too much OncoTICE
In the unlikely event that more than one vial is administered, you will be monitored
for signs of BCG infection, and if indicated, you may be treated with anti-tuberculosis
medication.
5. What should I know while using OncoTICE?
Things you should do
Refrain from drinking any fluid in the four hours prior to receiving this product
and during the two hours the OncoTICE remains in the bladder.
It is important you move around while OncoTICE is in the bladder. The solution must
remain in the bladder for two hours and you should not empty your bladder during this
period. After two hours the bladder should be emptied in a sitting position
For six hours after treatment the bladder should continue to be emptied in a sitting
position.
Two cups of household bleach should be added to the toilet containing the urine and
left to stand for 15 minutes before flushing.
Remind any healthcare provider you visit that you are using OncoTICE.
Driving or using machines
There is no warning that your ability to drive or operate machines will be affected.
Looking after your medicine
Store OncoTICE at 2°C to 8°C, protect from light and use before the expiry date on
the product label. The product in solution can be stored for a maximum of 2 hours
under these conditions.
Keep it where young children cannot reach it.
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.
OncoTICE is generally well tolerated.
If you do experience unusual symptoms or feel unwell after receiving this medication,
please inform your healthcare provider.
See the information below and, if you need to, ask your healthcare provider if you
have any further questions about side effects.
Very Common side effects (in more than 10% patients)
|
Very Common side effects
|
What to do
|
|
Bladder inflammation
Painful urination, urinary frequency, and blood in the urine.
In general, these symptoms disappear within two days.
Flu-like symptoms such as fever, fatigue and malaise (feeling of discomfort).
These symptoms usually occur as soon as 4 hours after treatment and last for 24 to
48 hours.
|
Speak to your healthcare provider if you have any of these side effects
|
Common side effects (1% -10% of patients)
|
Common side effects
|
What to do
|
|
Painful joints
Arthritis
Muscular pain
Nausea and vomiting
Abdominal pain
Diarrhoea
Lung inflammation
Anaemia
Loss of urine
Urinary tract infection
Urge to urinate
Abnormal urine lab test
Feverish shivers
|
Speak to your healthcare provider if you have any of these side effects.
|
Uncommon side effects (0.1% - 1% of patients)
Rare side effects (0.01% - 0.1% of patients):
Very Rare side effects (less than 0.01% patients)
|
Very Rare side effects
|
What to do
|
|
Hair loss
Increased perspiration
Dizziness (sensation of spinning)
Headache
Increased muscle tension
Abnormal sensation such as prickling, burning, pins and needles or itching
Conjunctivitis
Loss of appetite
Indigestion and gas
Confusion
Weight loss
Low blood pressure
Bronchitis
Shortness of breath
Sore throat
Runny nose
Swelling of lymph glands
Insufficient function of the kidney
Granuloma (nodule in an organ)
Inflammation of the glans
Inflammation of the testicles
Reiter's syndrome (inflammation of the eyes, joints and genitourinary system)
Lupus vulgaris (tuberculosis of the skin)
Inflammation of the prostate
Elevation of Prostatic specific antigen (PSA) (prostate laboratory test)
Burning, itching and soreness in the female genital area
Back pain
Chest pain
Fluid retention in the limbs
|
Speak to your healthcare provider if you have any of these side effects.
|
Other side effects
|
Other observed side effects
|
What to do
|
|
Allergic reactions
BCG infection in the blood (sepsis)
Abnormal arterial dilation for bacterial infection (infective aneurysm)
Inflammation of the blood vessels
|
Speak to your healthcare provider if you have any of these side effects.
|
|
Side effects (Unknown frequency)
|
What to do
|
|
Osteomyelitis (infection of bone)
Intervertebral discitis (infection in the spinal disc)
A serious and potentially life-threatening condition where the immune system becomes
overactive and produces too many infection fighting cells, which can cause inflammation
and damage to body’s own tissues and organs (hemophagocytic lymphohistiocytosis).
Symptoms may include fever that doesn’t go away, feeling very tired or weak, looking
pale, feeling lightheaded or short of breath, or easy bruising
|
Speak to your doctor healthcare provider if you have any of these side effects.
|
In case you develop these symptoms or any new or worsening symptoms, you are advised
to contact your healthcare provider, immediately.
Tell your healthcare provider 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 healthcare provider before you decide to stop taking
any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What OncoTICE contains
|
Active ingredient
(main ingredient)
|
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)
|
|
Other ingredients
(inactive ingredients)
|
lactose monohydrate asparagine
citric acid monohydrate
dibasic potassium phosphate magnesium sulfate heptahydrate
ferric ammonium citrate glycerol
zinc formate dihydrate
strong ammonia solution.
|
Do not take this medicine if you are allergic to any of these ingredients.
What OncoTICE looks like
OncoTICE is a freeze-dried preparation containing two hundred million - eight hundred
million Colony Forming Units of Mycobacterium bovis (Bacillus Calmette and Guerin
(BCG) strain) in sealed glass vials (Aust R 59912).
Who distributes OncoTICE
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A 26 Talavera Road
Macquarie Park NSW 2113 Australia
This leaflet was prepared in October 2025.
RCN000028118-AU
Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.