Oncotice

OncoTICE is a medicine used to treat bladder cancer or prevent it from returning.

Form
jauhe suspensiota varten, virtsarakkoon
Strength
2-8 x 10exp8
Active Ingredient
Bacillus Calmette Guerin bacteria, live, attenuated
Manufacturer
Merck Sharp & Dohme B.V.

How to Use

Dosage

The contents of one diluted vial are administered into the bladder per treatment.

Method

The medicine is given into the bladder through a catheter once a week for the first six weeks. The medicine must stay in the bladder for two hours, and the patient should be turned often during this time to ensure the medicine covers the entire inner surface of the bladder.

Important

After the initial treatment, the medicine is continued once a week for three weeks during the third, sixth, and twelfth months from the start of treatment. After this, the need for further treatment is assessed every six months.

Possible Side Effects

COMMON
  • Urinary tract infection
  • Anemia (low red blood cell count)
  • Lung inflammation
  • Stomach pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Joint pain
  • Joint inflammation
  • Muscle pain
  • Bladder inflammation (cystitis)
  • Pain when urinating
  • Frequent urge to urinate
  • Blood in urine
  • Loss of bladder control (urinary incontinence)
  • Urgent need to urinate
  • Abnormal urine test results
  • Flu-like symptoms
  • Fever
  • General feeling of being unwell
  • Tiredness
RARE
  • Widespread BCG infection (like tuberculosis)
  • Sore throat (pharyngitis)
  • Testicle inflammation
  • Reiter's syndrome (joint pain, eye inflammation, urinary problems)
  • Lupus vulgaris (skin infection)
  • Severe infection (sepsis)
  • Infected blood vessel bulge (aneurysm)
  • Low counts of all blood cells
  • Low platelet count (platelets help blood clot)
  • Swollen lymph nodes
  • Allergic reaction
  • Loss of appetite
  • Feeling confused
  • Dizziness or spinning sensation
  • Abnormal or unpleasant sensation
  • Increased sensitivity to touch
  • Tingling or numbness
  • Feeling sleepy
  • Headache
  • Muscle stiffness or increased muscle tone
  • Nerve pain
  • Eye inflammation (pink eye)
  • Severe eye infection
  • Low blood pressure
  • Blood vessel inflammation
  • Cough
  • Bronchitis (inflammation of airways)
  • Shortness of breath
  • Runny nose
  • Indigestion
  • Gas or bloating
  • Liver inflammation (hepatitis)
  • Skin rashes or eruptions
  • Back pain
  • Bladder muscle contraction
  • Pus in urine
  • Inability to empty bladder completely (urinary retention)
  • Blockage of tubes from kidney to bladder
  • Sudden kidney failure
  • Testicle tube inflammation (epididymitis)
  • Foreskin and glans inflammation
  • Prostate inflammation
  • Discomfort in external genital area (for men and women)
  • Shivering or chills
  • Chest pain
  • Swelling in arms or legs
  • Small clumps of immune cells (granuloma)
  • Higher levels of liver enzymes in blood tests
  • Increased PSA (Prostate-Specific Antigen)
  • Weight loss
  • Hair loss
  • Increased sweating

Important Warnings

  • Do not use if you have a urinary tract infection. Treatment will be stopped until the infection is gone.
  • Do not use if you have a lot of blood in your urine. Treatment will be stopped until the bleeding has stopped or been treated.
  • Do not use if you have active tuberculosis.
  • Do not use if you are taking certain tuberculosis medicines (like streptomycin, isoniazid, rifampicin, etambutol).
  • Do not use if your immune system is weak.
Show 6 more warnings
  • Do not use if you have HIV infection, are pregnant, or breastfeeding.
  • If the lining of your bladder is damaged, for example from a catheter, the medicine should not be given until the lining has healed.
  • This medicine must not be injected into a vein, under the skin, or into a muscle.
  • You should avoid sex or use a condom for one week after treatment.
  • If the medicine spills, clean the area carefully with a disinfectant that kills tuberculosis bacteria.
  • If the medicine accidentally gets on your skin, in a wound, or if you breathe it in or swallow it, contact a doctor immediately.