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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

Learn about ONCOTICE® (2-8 x 108 CFU Tice BCG)

Prescribing Information

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Indication1

  • ONCOTICE is indicated for treatment of primary or concurrent carcinoma-in-situ of the urinary bladder and for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (Stage Ta (grade 2 or 3) or T1 (grade 1, 2 or 3)) after
    transurethral resection
  • ONCOTICE is only recommended for stage Ta grade 1 papillary tumours, when there is judged to be a high risk of tumour recurrence

Reconstitution and instillation of ONCOTICE

The animated video is intended to give guidance on the reconstitution and instillation of ONCOTICE into
the bladder.

Prescribing Information

ONCOTICE Selected Safety Information

For complete information on the prescribing and safety information relating to use of ONCOTICE please refer to the Summary of Product Characteristics.

Contraindications

  • Gross haemoturia, impaired immune response (irrespective of cause); positive Tuberculin test if there is supplementary medical evidence for an active tuberculosis infection. During treatment with anti-tuberculosis drugs like streptomycin, para-amino-salicyclic acid (PAS), isoniazid (INH), rifampicin and ethambutol
  • Urinary tract infections; interrupt therapy until bacterial culture from urine becomes negative and therapy with antibiotics and/or urinary antiseptics is stopped
  • Positive HIV serology
  • Pregnancy and lactation

Precautions

A Tuberculin test (PPD) should be performed before first instillation. Traumatic catheterisation or other injuries to the urethra or bladder mucosa can promote systemic BCG infection.

Side effects – refer to SmPC for complete information on side effects

Very common side effects include but not limited to cystitis or bladder irritation such as dysuria, pollakiuria and haematuria. Malaise, a low to medium grade fever and/or flu-like symptoms which may accompany the localised irritative toxicities that often reflect hypersensitivity reactions have been commonly observed. Fatigue.

Related content

 

Reference

  1. ONCOTICE Summary of Product Characteristics.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-XTB-00047 | Date of Preparation: September 2020