Oncotice

Bacillus Calmette and Guerin (BCG, strain Tice)
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Oncotice. It does not contain all the information that is known about Oncotice. 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 OncoTICE is used for

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.

Before you are given OncoTICE

Do not take OncoTICE if:
you have a urinary tract infection. If you have cystitis, you will receive a course of antibiotics before treatment with OncoTICE starts. The treatment with antibiotics needs to be finished before treatment with OncoTICE is commenced.
you have blood in your urine
you have active tuberculosis.
Your doctor will probably do a skin reaction test (Mantoux) to assist in making this diagnosis.
you are being treated with anti-tuberculosis drugs.
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
Take special care with OncoTICE in the following situations:
Before the first intravesical instillation of OncoTICE, your doctor will probably perform a skin reaction test (Mantoux) to investigate if you have an active tuberculosis infection.
When the bladder wall or ureter is damaged during catheterisation, treatment should 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 doctor may also ask if there are any risk factors, such as unsafe sex, use of dirty needles if you are a drug user and 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.
OncoTICE should not be administered to children.

Taking other medicines

Tell your doctor if you are taking any other medication.
The following medicines/therapies can reduce the effects of OncoTICE:
Antibiotics
Treatment for tuberculosis
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 doctor will postpone treatment with OncoTICE.

How OncoTICE is given

OncoTICE will be introduced into the bladder by a doctor or nurse.
The contents of one vial will be dissolved in 50mL of saline solution. A sterile tube 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.
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.
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 doctor 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 doctor will decide on the duration and frequency of treatment for you.

If you are given too much (overdose)

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.

While you are using OncoTICE

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.

Side effects

OncoTICE is generally well tolerated.
If you do experience unusual symptoms or feel unwell after receiving this medication please inform your doctor.
After treatment with OncoTICE you may suffer from one or more of the common (in more than 10% patients) side effects:
Bladder infection
Painful urination, urinary frequency, urgency and blood in the urine. In general these symptoms disappear within two days.
Flu-like symptoms such as fever and a feeling of discomfort. These symptoms usually occur as soon as 4 hours after treatment and last for 24 to 48 hours.
The following side effects occur less frequently (1% -10% of patients):
Painful joints
Arthritis
Muscular pain
Nausea and vomiting
Abdominal pain
Diarrhoea
Airway infection
Anaemia
Loss of urine
A large amount of blood in urine
Feverish shivers
Uncommon side effects (0.1% - 1% of patients):
Skin rash
Hepatitis associated with jaundice (yellow colouration of the skin or eyes)
Pus in the urine
Decreased amount of red blood cells or platelets possibly associated with symptoms such as fatigue and/or bruises
Difficult urination
BCG infection in the blood
Rare side effects (0.01% - 0.1% of patients):
Cough
Inflammation of the epididymis
The following side effects occur very rarely (less than 0.01% patients):
Hair loss
Increased perspiration
Dizziness
Headache
Increased muscle tension
Abnormal sensation such as prickling or itching
Conjunctivitis
Loss of appetite
Confusion
Weight loss
Low blood pressure
Bronchitis
Tightness of the chest
Sore throat
Cold in the nose
Swelling of lymph glands
Insufficient function of the kidney
Inflammation of the glands
Inflammation of the testicles
Inflammation of the prostate
Back pain
Chest pain
Fluid retention in the limbs

After using OncoTICE

Storage

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.

Product description

Ingredients

OncoTICE is a freeze dried preparation containing two hundred million - eight hundred million Colony Forming Units of Calmette and Guerin (BCG strain Tice) in sealed glass vials. In addition to the active ingredient, BCG, OncoTICE contains the following additives: lactose, asparagine, citric acid monohydrate, potassium phosphate (dibasic), magnesium sulphate, ferric ammonium citrate, glycerol, zinc formate and ammonium hydroxide.

Supplier

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A
26 Talavera Road
Macquarie Park NSW 2113
Australia
 
Vials: AUST R 59912
 
This leaflet was revised November 2014.