Oncotice

Package Leaflet: Information for the User

OncoTICE, (BCG ad immunocurationem), BCG for immunotherapy,

2-8 x 10 CFU of live, attenuated BCG (Bacillus Calmette-Guerin) bacteria, TICE strain

TICE, powder for suspension for intravesical use

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is OncoTICE and what is it used for
• 2. Important information before using OncoTICE
• 3. How to use OncoTICE
• 4. Possible side effects
• 5. How to store OncoTICE
• 6. Contents of the package and other information

1. What is OncoTICE and what is it used for

OncoTICE belongs to a group of medicines called immunostimulants. These medicines stimulate the immune system.
OncoTICE is a powder used to prepare a suspension, which after reconstitution is administered into the bladder through a catheter.
OncoTICE is used to treat superficial bladder cancer. It is also used to prevent recurrence of the disease after surgical procedures on the bladder.

2. Important information before using OncoTICE

When not to use OncoTICE

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have a urinary tract infection. In the case of cystitis, before starting treatment with OncoTICE, you should first receive antibiotic treatment. OncoTICE can be used after completing antibiotic treatment.
• If you have blood in your urine.
• If you have active tuberculosis. Your doctor may recommend a skin test (Mantoux test).
• If you are taking anti-tuberculosis medicines.
• If you have impaired immune system function (reduced resistance to infectious diseases), regardless of the cause of this impaired immunity.
• If you have HIV infection.
• During pregnancy or breastfeeding.

Warnings and precautions

Before starting treatment with OncoTICE, discuss it with your doctor.

• Before the first intravesical administration of OncoTICE, your doctor may perform a skin test (Mantoux test) to rule out active tuberculosis.
• In the event of damage to the bladder or ureter during catheterization, treatment with OncoTICE should be postponed until the damaged areas have healed.
• It is very important to rule out HIV infection. A blood test for HIV may be necessary. Your doctor may also ask about risk factors, such as unprotected sex, sharing needles, using drugs, or having a blood transfusion.
• Considering the safety of your partner, it is recommended to avoid sexual intercourse for one week after completing therapy with OncoTICE. If a condom is used, there is no need to avoid sexual intercourse, provided it is used correctly and is not damaged.
• The result of the skin test (Mantoux test) performed after therapy with OncoTICE may be positive.
• If you experience symptoms such as fever and unexplained weight loss, you should contact your doctor, as these symptoms may indicate late onset of BCG infection symptoms. These symptoms may be delayed by months or years after the last dose of OncoTICE.

OncoTICE and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Medicines or treatments listed below may reduce the effectiveness of OncoTICE:

• Antibiotics
• Immunosuppressive medicines
• Medicines that inhibit bone marrow production
• Radiation therapy

In the case of using these medicines or treatments, your doctor may decide to postpone the administration of OncoTICE until the current treatment is completed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
Using OncoTICE is contraindicated during pregnancy and breastfeeding.

Driving and using machines

OncoTICE has no influence or negligible influence on the ability to drive and use machines.

3. How to use OncoTICE

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor.
Your doctor will decide on the dosage of OncoTICE.
OncoTICE is usually administered intravesically once a week for 6 weeks. Then the medicine is used once a week for 3 consecutive weeks in the 3rd, 6th, and 12th month from the start of treatment.
If necessary, the 3-week treatment can be repeated every 6 months.
Method of administration

OncoTICE should be administered into the bladder by a doctor or nurse

The contents of one vial should be reconstituted in 50 ml of saline solution. Before administering the medicine, the bladder should be emptied using a catheter, through which OncoTICE will then be introduced into the bladder. It is essential not to drink any fluids for 4 hours before administration. To achieve optimal treatment results, the OncoTICE suspension should remain in the bladder for 2 hours. The medicine should have adequate contact with the entire surface of the bladder mucosa, so the patient should move around. During this time (2 hours), you should not urinate.
It is essential to urinate in a sitting position for 6 hours after the end of administration and to pour two cups of bleach into the toilet before flushing, waiting 15 minutes before flushing the water.

Using a higher dose of OncoTICE than recommended

Medical personnel prepare the OncoTICE suspension from the contents of one vial, so administering too high a dose of OncoTICE is unlikely. However, if such a situation occurs, the doctor will check for symptoms of BCG infection and, if necessary, prescribe anti-tuberculosis medicines.

Missing a dose of OncoTICE

Not applicable.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people):

• cystitis
• pain during urination, frequent urination, and hematuria. These symptoms usually resolve within 2 days.
• flu-like symptoms, such as fever, fatigue, and malaise. These symptoms usually occur within 4 hours of administration and last for 24 to 48 hours.

Common side effects (may affect up to 1 in 10 people) include:

• joint pain
• arthritis
• muscle pain
• nausea and vomiting
• abdominal pain
• diarrhea
• pneumonia
• anemia
• urinary incontinence
• urinary tract infection
• urgent need to urinate
• abnormal urine test results
• fever with chills

Uncommon side effects (may affect up to 1 in 100 people) include:

• skin rash
• hepatitis with jaundice (yellowing of the skin and/or eyes)
• abnormal liver function test results
• reduced red blood cell or platelet count, which may cause fatigue and/or bruising
• reduced white blood cell count
• pyuria
• urination difficulties
• bladder contraction and obstructed urine flow
• BCG infection in the body (tuberculous infections) with possible late onset of symptoms. Symptoms may be delayed by months or years after the last dose of OncoTICE

Rare side effects (may affect up to 1 in 1,000 people) include:

• cough
• epididymitis

Very rare side effects (may affect up to 1 in 10,000 people) include:

• hair loss
• excessive sweating
• dizziness (feeling of spinning)
• headache
• excessive muscle tension
• abnormal sensation of tingling, burning, prickling, or itching
• conjunctivitis
• loss of appetite
• indigestion and bloating
• disorientation
• drowsiness
• weight loss
• reduced blood pressure
• bronchitis
• shortness of breath
• sore throat
• runny nose
• lymph node swelling
• abnormal kidney function
• granuloma (a nodule in an organ)
• glans penis inflammation
• testicular inflammation
• Reiter's syndrome (inflammation of the eyes, joints, and genitourinary system)
• tuberculous lupus (tuberculosis of the skin)
• prostatitis
• increased prostate-specific antigen (PSA) levels (laboratory test for prostate disorders)
• burning, itching, and pain in the female genital area
• back pain
• chest pain
• fluid retention in the limbs

Side effects with unknown frequency (frequency cannot be estimated from available data):

• vasculitis, including cerebral vasculitis (inflammation of blood vessels)
• endophthalmitis (infectious inflammation of the inner eye)

Other observed side effects include:

• allergic reactions
• BCG bacteremia (sepsis)
• bacterial aneurysm (abnormal dilation of a blood vessel due to bacterial infection)

If you experience significant intensification or prolongation of the above symptoms for more than 48 hours, you should consult your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store OncoTICE

Keep this medicine out of the sight and reach of children.
OncoTICE should be stored in a hospital pharmacy according to the instructions on the packaging.
Store in a refrigerator (2°C - 8°C). Store in the original packaging to protect from light.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What OncoTICE contains

• The active substance of OncoTICE is 2-8 x 10 CFU - live Bacillus Calmette-Guerin (BCG) bacteria, TICE strain. These are attenuated (non-virulent) bacteria.
• The other ingredients are: lactose monohydrate, asparagine monohydrate, citric acid monohydrate, dipotassium phosphate, magnesium sulfate heptahydrate, ammonio ferric citrate, glycerol, ammonium hydroxide, zinc acetate.

What OncoTICE looks like and contents of the package

The package contains 1 or 3 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

MSD Polska Sp. z o.o.
ul. Chłodna 51
00-867 Warsaw
Tel. (+48) 22 54 95 100
[email protected]

Manufacturer

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

Date of last revision of the package leaflet: 07/2023