Intravesical Immunotherapy Pregnancy: US label: animal reproduction studies have not been conducted with TICE BCG; it is not known whether it can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. 'TICE BCG should not be given to a pregnant woman except when clearly needed. Women should be advised not to become pregnant while on therapy.'

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.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1 vial of TICE BCG suspended in 50 mL preservative-free saline (0.9% Sodium Chloride Injection USP), instilled into the bladder

Route: Intravesical instillation by gravity flow via urinary catheter; the catheter is removed after instillation and the suspension is retained in the bladder for 2 hours, then voided. 'Do not inject subcutaneously or intravenously.'

Frequency: One intravesical instillation per week for 6 weeks. 'This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Thereafter, intravesical TICE BCG administration should continue at approximately monthly intervals for at least 6 to 12 months.'

SOURCE MISMATCH — READ FIRST: the eMC record fetched in this bundle is 'BCG Vaccine AJV', an INTRADERMAL TUBERCULOSIS VACCINE (§4.2: 0.1 mL intradermally for adults and children aged 12 months and over; 0.05 mL for infants under 12 months). That is a different product, route and indication from intravesical BCG immunotherapy for bladder cancer and it was NOT used for the dose above — the vaccine posology must never be applied to this urology page. The dose above is taken from the US labelling for TICE BCG (Merck Sharp & Dohme LLC, label date 2026-02-20), whose indication does match this page: 'intravesical treatment of carcinoma in situ and ... prophylaxis of recurrent papillary tumors'. A UK intravesical BCG SPC should be obtained and the regimen re-verified before publication. TIMING: 'Allow 7 to 14 days to elapse after bladder biopsy before TICE BCG is administered.' PATIENT PREPARATION: 'Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to TICE BCG administration.' Patients unable to retain the suspension for 2 hours should be allowed to void sooner if necessary; while retained, the patient should ideally be repositioned left side, right side, back and abdomen every 15 minutes to maximise bladder surface exposure. PREPARATION: resuspend 1 vial in 1 mL sterile preservative-free saline at 4–25°C, swirl gently (avoid forceful agitation, which clumps the mycobacteria), then dilute to a final volume of 50 mL; do NOT filter the vial contents; bacteriostatic solutions must be avoided; keep the reconstituted suspension refrigerated (2–8°C), protected from direct sunlight, and use within 2 hours; discard the unused portion. Handle all equipment and receptacles as biohazardous; do not prepare parenteral drugs in the area used for BCG. 'There are no data to support the interchangeability of BCG LIVE products.' PAEDIATRIC (US §8.4): 'Safety and effectiveness of TICE BCG for the treatment of superficial bladder cancer in pediatric patients have not been established' — verify any under-18 use against a children's formulary. The US adverse-reactions section was truncated at the source-fetch limit.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Immunosuppressed patients — congenital or acquired immune deficiency, whether from concurrent disease (e.g. AIDS, leukaemia, lymphoma), cancer therapy (cytotoxic drugs, radiation) or immunosuppressive therapy (e.g. corticosteroids)
Patients at increased risk of BCG infection — postpone treatment until resolution of a concurrent febrile illness, urinary tract infection or gross haematuria; 7 to 14 days should elapse after biopsy, TUR or traumatic catheterisation
Active tuberculosis — do not administer; active tuberculosis should be ruled out in PPD-positive individuals before starting treatment
(From the UK BCG Vaccine AJV SPC §4.3, for the intradermal vaccine product and listed here only as cross-reference: hypersensitivity to the active substance or excipients; acute severe febrile illness or generalised infected skin conditions; systemic corticosteroids or other immunosuppressive treatment including radiotherapy; malignant conditions; primary or secondary immunodeficiency; HIV infection; patients receiving anti-tuberculosis drugs)

Side effects

Symptoms of bladder irritability in approximately 60% of patients, typically beginning 4 to 6 hours after instillation and lasting 24 to 72 hours; usually seen after the third instillation and tending to increase in severity with each administration
'Flu-like' symptoms — malaise, fever and chills — which may accompany the localised irritative toxicities and often reflect hypersensitivity reactions treatable symptomatically
Adverse reactions tend to be progressive in frequency and severity with subsequent instillations; delay or postponement of subsequent treatment may or may not reduce severity
Serious infectious complications of intravesical BCG have been reported, although uncommon
There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative toxicity of TICE BCG

Interactions

Immunosuppressants and/or bone marrow depressants and/or radiation — interfere with the development of the immune response and should not be used in combination with TICE BCG
Antimicrobial therapy for other infections may interfere with the effectiveness of TICE BCG
Antituberculosis drugs (e.g. isoniazid) should not be used to prevent or treat the local, irritative toxicities of TICE BCG — there are no data suggesting the acute local urinary tract toxicity is due to mycobacterial infection

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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways