Oncotice

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)

Consumer Medicine Information

This information has been provided to help understand how this product works and to answer some common questions about OncoTICE. If you need more information, please ask your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given OncoTICE against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet.

You may need to read it again.

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.

Do not take OncoTICE if:

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 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 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 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.

If a skin test (Mantoux test) is performed after treatment with OncoTICE, it may be positive.

Driving and using machines: There is no warning that your ability to drive or operate machines will be affected.

OncoTICE should not be administered to children.

Tell your doctor if you are taking any other medication.

The following medicines/therapies can reduce the effects of OncoTICE:

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 doctor will postpone treatment with OncoTICE.

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.

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.

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.

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 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 a malaise (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

Lung inflammation

Anaemia

Loss of urine

Urinary tract infection

Urge to urinate

Abnormal urine lab test

Feverish shivers

 

Uncommon side effects (0.1% – 1% of patients):

Skin rash

Hepatitis associated with jaundice (yellow colouration of the skin or eyes)

Abnormal liver function test

Pus in the urine

Decreased amount of red blood cells or platelets possibly associated with symptoms such as fatigue and/or bruises

Decrease of white blood cells

Difficult urination

Bladder constriction and blocked urine flow

Tuberculous infections

 

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 (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

 

Other observed side effects are

Allergic reactions

BCG infection in the blood (sepsis)

Abnormal arterial dilation for bacterial infection (infective aneurysm)

Inflammation of the blood vessels

In case your symptoms are severe or last longer than 48 hours, you are advised to contact your doctor. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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.

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. In addition to the active ingredient, BCG, OncoTICE contains the following additives: lactose monohydrate, asparagine, citric acid monohydrate, dibasic potassium phosphate, magnesium sulfate heptahydrate, ferric ammonium citrate, glycerol, zinc formate dihydrate and strong ammonia solution.

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 on

10 May 2019