Intravesical Immunotherapy
Pregnancy: OncoTICE instillation for carcinoma of the bladder is contraindicated during pregnancy and lactation (see section 4.3).
Bacillus Calmette-Guerin (BCG)
Brand names: ImmuCyst, OncoTICE
Bacillus Calmette-Guerin (BCG) is a live attenuated strain of Mycobacterium bovis instilled into the bladder as immunotherapy for non-muscle-invasive bladder cancer.
Adult dose
Dose: Primary or concurrent carcinoma-in-situ of the urinary bladder, and prevention of recurrence of high-grade and/or relapsing superficial papillary transitional cell carcinoma (stage Ta grade 2 or 3, or T1 grade 1, 2 or 3) after transurethral resection: the contents of ONE vial of OncoTICE (BCG 12.5 mg per vial, containing 2-8 x 10^8 CFU Tice BCG), reconstituted and diluted as the SPC directs to a 50 ml suspension in saline (0.4-1.6 x 10^7 CFU/ml), instilled into the bladder
Route: Intravesical instillation only: catheter passed via the urethra, bladder drained completely, 50 ml suspension instilled (by gravity flow if no closed-system transfer device is available), catheter removed, suspension retained in the bladder for 2 hours, then voided in a sitting position. Not for intravenous, subcutaneous or intramuscular administration.
Frequency: Induction: one instillation weekly for the first 6 weeks (when used as adjuvant after TUR, start between 10 and 15 days after the TUR, and not until mucosal lesions have healed; delay if gross haematuria or major bladder irritability). Maintenance: weekly instillation for 3 consecutive weeks at months 3, 6 and 12 after initiation of treatment; the need for maintenance every 6 months beyond the first year is evaluated on tumour classification and clinical response.
SOURCE: UK SPC via MHRA Products — OncoTICE (PL530950003), Merck Sharp & Dohme (UK) Limited. This replaces the earlier US-label (TICE BCG) card; the UK schedule differs (for example, the UK maintenance schedule is 3 weekly instillations at months 3, 6 and 12). SCOPE: this card covers OncoTICE only; ImmuCyst, also named on this page, is NOT covered. Not the intradermal BCG vaccine, which is a different product. INDICATION LIMIT: the SPC recommends OncoTICE for stage Ta grade 1 papillary tumours only when there is judged to be a high risk of tumour recurrence. The SPC prints no separate maximum dose. PATIENT PREPARATION: the patient must not ingest any fluid from 4 hours before instillation until bladder evacuation is permitted (2 hours after instillation). During the 2-hour retention the patient should not be immobilised; a bed-ridden patient should be turned from back to abdomen and vice versa every 15 minutes so the whole bladder mucosa is in contact with the suspension. AFTER TREATMENT: urine should be voided in a sitting position for 6 hours after treatment, with two cups of household bleach added to the toilet before flushing, and the bleach and urine left to stand for 15 minutes before flushing. To protect the partner, advise refraining from intercourse within one week after instillation or using a condom. PREPARATION: reconstitution and dilution instructions are in SPC section 6.6, which was not retrieved here — follow the SPC; prepare under aseptic conditions; spillage of suspension should be covered with paper towels soaked in tuberculocidal disinfectant such as household bleach for at least 10 minutes and all waste disposed of as biohazard material. PAEDIATRIC: SPC states 'No data are available'; no paediatric dose is given. Some sections of the product information we used were incomplete — check the full SPC.
Dose adjustments
Renal
Not stated — no renal-impairment dosing statement appears in the SPC text that was retrieved.
Hepatic
Not stated — no hepatic-impairment dosing statement appears in the SPC text that was retrieved.
Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.
Contraindications
- Urinary tract infections — therapy should be interrupted until the urine culture becomes negative and antibiotic and/or urinary antiseptic therapy has stopped
- Gross haematuria — stop or postpone OncoTICE until the haematuria has been successfully treated or has resolved
- Positive tuberculin test — instillations are contraindicated only if there is supplementary medical evidence of active tuberculous infection
- Treatment with anti-tuberculosis drugs such as streptomycin, para-amino-salicylic acid (PAS), isoniazid (INH), rifampicin and ethambutol
- Impaired immune response, whether congenital or caused by disease, drugs or other therapy
- Positive HIV serology
- Pregnancy and lactation
Side effects
- Local bladder irritative symptoms in approximately 90% of patients; pollakiuria and dysuria are reported very frequently; in most cases the symptoms disappear within two days after instillation and the cystitis does not require treatment
- Cystitis symptoms may be more pronounced and prolonged during maintenance treatment; for severe symptoms the SPC states that isoniazid (300 mg daily) and analgesics can be given until the symptoms disappear
- Toxicity and side-effects appear to be directly related to the cumulative CFU count of BCG administered with the various instillations
- Post-marketing reactions listed in the SPC table include cystitis, dysuria, pollakiuria, haematuria, influenza-like illness, pyrexia, malaise, fatigue, urinary tract infection, anaemia, pneumonitis, abdominal pain, nausea, vomiting, diarrhoea, arthralgia, arthritis, myalgia and urinary incontinence (the frequency band for each term could not be read reliably from the PDF text)
- Also listed: tuberculous infections, pancytopenia, thrombocytopenia, hepatitis, raised hepatic enzymes, epididymitis and orchitis (frequency bands not reliably readable from the PDF text)
- Traumatic catheterisation or other injury to the urethra or bladder mucosa can promote systemic BCG infection
- OncoTICE may sensitise patients to tuberculin, resulting in a positive reaction to PPD
- This side-effect list may be incomplete — check the full SPC.
Interactions
- Antibiotics: Tice BCG is sensitive to most antibiotics, in particular the anti-tuberculosis drugs streptomycin, PAS, isoniazid, rifampicin and ethambutol, so anti-tumour activity may be influenced; if a patient is on an antibiotic, postpone the instillation until the end of antibiotic treatment
- Immunosuppressants and/or bone marrow depressants and/or radiation may interfere with the development of the immune response and the anti-tumour efficacy and should not be used in combination with OncoTICE
Monitoring
- Tuberculin test (PPD) before the first intravesical instillation
- Monitor for symptoms of systemic BCG infection and signs of toxicity after each intravesical treatment
- Patients known to be at risk of HIV infection should be adequately screened before starting therapy
- Delay administration after traumatic catheterisation or other urethral or bladder mucosal injury until the damage has healed
- Accidental exposure (self-inoculation, open wound, inhalation or ingestion of the suspension): PPD skin testing is advised at the time of the accident and six weeks later
- Reconstitution and administration under aseptic conditions; handle spillage and waste as biohazard material
Clinical monograph
How it works
Intravesical BCG triggers a local immune response, attracting immune cells and provoking an inflammatory reaction within the bladder wall that has antitumour activity against superficial urothelial cancer.
Prescribing in practice
- It is a live organism that can cause local and disseminated BCG infection (BCGosis); traumatic catheterisation, active urinary infection or gross haematuria are contraindications to instillation.
- Should not be used in immunocompromised patients owing to the risk of serious systemic infection.
- Prepare and handle with appropriate precautions and avoid instillation soon after bladder biopsy or resection until the urothelium has healed.
Monitoring
Monitor for persistent fever, systemic symptoms or worsening urinary symptoms suggesting BCG infection, and review urine and cystoscopic findings.
Counselling the patient
- Expect transient bladder irritation and mild flu-like symptoms after instillation.
- Seek urgent medical advice for a high or persistent fever, rigors or symptoms lasting beyond a couple of days.
Evidence & guidelines
Intravesical BCG is established standard care for high-risk non-muscle-invasive bladder cancer in NICE guidance and international urology guidelines.
Reference: NICE NG2 (Bladder Cancer); EAU Bladder Cancer Guidelines 2024; SWOG S8507 Trial; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
Calculators
