12.5 mg powder for solution for intravesical use
BCG for immunotherapy
What OncoTICE is and what it is used for
OncoTICE belongs to a group of medicines called immunostimulatory medicines. These drugs stimulate certain parts of the immune system.
OncoTICE is used to treat superficial bladder cancer. It is also used to prevent the recurrence of the disease after surgery on the bladder.
What you need to know before you receive OncoTICE
You can not get 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 weakened immune system (reduced immunity to infectious diseases) no matter what it is caused by.
- if you are HIV positive.
- if you have active tuberculosis.
- if you have an ongoing urinary tract infection.
- if you have blood in your urine.
- if you are being treated with tuberculosis drugs .
- if you are pregnant or breastfeeding.
You can not get OncoTICE if any of the above conditions apply to you. If you are not sure, talk to your doctor before taking OncoTICE.
Warnings and cautions
Talk to your doctor or nurse before using OncoTICE.
- To protect your partner from the transmission of the BCG bacterium, you should refrain from intercourse or use a condom for up to a week after the OncoTICE treatment. If you use a condom, you may have intercourse, provided the condom is used correctly and does not break.
- Before the first treatment with OncoTICE, your doctor will probably perform a Tuberculin (PPD) test to see if you have active tuberculosis .
- If a Tuberculin (PPD) test is performed after treatment with OncoTICE, the result may be positive.
- If the bladder wall or urethra is damaged during instillation one, the treatment needs to be postponed until the injury has healed.
- It is important that you do not have HIV infection . It may be necessary to take a blood test for HIV testing. Your doctor may also ask if there are any risk factors, such as unprotected sex, use of unclean needles if you are using drugs or blood transfusions .
- In connection with the treatment, you may experience a general feeling of illness with fever and / or flu-like symptoms such as chills and muscle pain, which may be due to a local hypersensitivity reaction . These symptoms usually develop within 4 hours of receiving OncoTICE and usually disappear after 1-2 days of treatment with antipyretics.
- Contact your doctor or healthcare provider if you have a fever over 39 degrees that does not go away within 12 hours of receiving OncoTICE despite treatment with antipyretics. These may be early symptoms of BCG infection in the blood.
- Symptoms of BCG infection may be delayed by months or years after the last dose of one with OncoTICE. If you get symptoms such as fever and weight loss for no known reason, consult a doctor as it may be a sign of a BCG infection flaring up.
Other medicines and OncoTICE
Tell your doctor if you are taking, have recently taken, or might take any other medicines. The following medicines or treatments may impair the effect of OncoTICE:
- antibiotics (drugs that reduce the number of bacteria in the body)
- immunosuppressive drugs (which inhibit the body’s immune system)
- bone marrow inhibitors (which inhibit the production of cells in the bone marrow )
- radiation therapy (a form of treatment that is common in cancer).
If you are taking any of these medicines or are receiving any of the above treatments, your doctor will probably postpone treatment with OncoTICE until you stop taking the medicine or stop taking the treatment.
Pregnancy and breastfeeding
OncoTICE should not be used during pregnancy.
OncoTICE should not be used by breastfeeding mothers.
Driving and using machines
OncoTICE is not expected to affect your ability to drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to get OncoTICE
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Dose one is determined by the doctor.
The usual treatment schedule is one treatment once a week for 6 weeks, followed by one treatment per week for 3 consecutive weeks at months 3, 6, and 12 after the start of treatment. If necessary, the 3-week treatment will be repeated every 6 months thereafter.
| OncoTICE should be inserted into the bladder by a doctor or nurse. |
The contents of a vial will be mixed in 50 ml of saline solution. First, your bladder will be emptied using a catheter, which is then used to inject OncoTICE into the bladder. You mustn’t drink any liquid for 4 hours before starting treatment. OncoTICE must be kept in the bladder for 2 hours to achieve the best results from the treatment. The drug should come in contact with the entire surface of the bladder. Therefore, you will be asked to change position, or if you are bedridden, you will be turned from supine to abdominal position and vice versa every 15 minutes. You mustn’t urinate before the end of the two-hour treatment.
You must urinate while sitting for the first 6 hours after the end of treatment.
Pour 500 ml of bleach (type sodium hypochlorite into water) into the toilet seat before each flush. The measure is to protect the next user of the toilet and to prevent contamination from entering the sewer system. The bleach and urine should be left in the toilet for 15 minutes before rinsing.
If you take more OncoTICE than you should
The OncoTICE solution is prepared by healthcare professionals from the contents of a vial and therefore it is unlikely that you can get too much OncoTICE. Should this happen in any case, your doctor will carefully check if you have any symptoms of BCG infection. If necessary, you will be given tuberculosis medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or healthcare provider if you have a fever over 39 degrees that does not go away within 12 hours of receiving OncoTICE despite treatment with antipyretics. These may be early symptoms of BCG infection in the blood.
Very common (may affect more than 1 user in 10)
- cystitis ( inflammation of the bladder), difficulty urinating, abnormally frequent urination, blood in the urine. As a rule, these symptoms disappear within two days.
- flu-like symptoms such as fever, fatigue and general malaise. These symptoms usually appear as soon as four hours after treatment and last for about 24-48 hours.
Common (may affect up to 1 in 10 people)
- urinary tract infection
- anemia
- pneumonia
- abdominal pain, nausea, vomiting, diarrhea
- joint pain, joint inflammation, muscle pain
- urinary incontinence, urinary incontinence, abnormal urinary values
- overindulge
Uncommon (may affect up to 1 in 100 people)
- BCG infection in the body (tuberculous infections ), which can also flare up late. Symptoms may be delayed and appear months to years after the last dose .
- lack of blood cells and platelets; this can cause symptoms such as fatigue and / or bruising
- yellowing of the skin or eyes, which may be a sign of hepatitis
- rash
- redness
- bladder constriction, urinary incontinence, inability to urinate, blocked urine flow
- increase in liver enzymes
Rare (may affect up to 1 in 1,000 people)
- cough
- inflammation of the epididymis
Very rare (may affect up to 1 in 10,000 people)
- sore throat
- testicular inflammation
- Reiter’s syndrome ( inflammation of eyes, joints, urethra)
- cutaneous tuberculosis (Lupus vulgaris)
- swollen lymph nodes
- loss of appetite
- confusion
- dizziness
- sensory disturbances (decreased or increased sensation, abnormal sensations such as tingling, burning, ant crawling or itching )
- drowsiness
- headache
- increased muscle tension
- nerve pain
- inflammation of the conjunctiva of the eye ( conjunctivitis )
- low blood pressure
- bronchitis , difficulty breathing, runny nose
- digestive disorder, flatulence
- hair loss
- increased sweating
- back pain
- acute renal failure
- inflammation of the glans and foreskin of men, prostate inflammation
- discomfort such as burning, itching and tenderness in the abdomen in women
- chest pain
- fluid accumulation in arms and legs
- granuloma (lump in any organ)
- weight loss
- increase in PSA (prostate -specific antigen ) in laboratory tests
Has been reported (occurs in an unknown number of users):
- inflammation of blood vessels including blood vessels in the brain ( vasculitis )
- inflammation of the eye ( infectious endophthalmitis )
- allergic reactions
- BCG infection in the blood ( sepsis )
- abnormal dilation of the blood vessels ( arteries ) due to bacterial infection (infected aneurysm )
If any of the side effects gets serious, or if you notice more than 48 hours, talk to your doctor.
How to store OncoTICE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP” and on the label after “EXP”.
Store at 2ºC-8ºC.
Store in the outer carton. Sensitive to light.
A reconstituted solution should be used immediately.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is live attenuated modified bacteria from Mycobacterium bovis BCG (Bacillus Calmette Guérin), strain Tice. One vial contains approximately 5 x 10 8 colony forming units (CFUs).
- The other ingredients are lactose monohydrate 150 mg, L-aspartic monohydrate, citric acid monohydrate, potassium dihydrogen phosphate, magnesium sulphate, iron ammonium citrate, glycerol , zinc formate and ammonium hydroxide.
What the medicine looks like and contents of the pack
OncoTICE is a white to off-white lyophilized powder for solution for intravesical use.
OncoTICE is supplied in glass bottles containing 12.5 mg of powder equivalent to approximately 5 x 10 8 CFU Tice BCG.
Each carton contains 3 vials.
Marketing Authorisation Holder
Merck Sharp & Dohme BV
Box 581
2003 PC Haarlem
Netherlands
Manufacturer
NV Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
MSD
Box 45192
104 30 Stockholm
Tel: 077-570 04 88