Superficial transitional cell carcinoma (TCC) of the urinary bladder
The induction treatment comprises 6 weekly intravesical treatments, each treatment dose comprising one 81 mg vial. After a 6-week pause, another dose should be given intravesically once weekly for 1 to 3 weeks. Three weekly doses is to be given to patients who still have evidence of bladder cancer. Maintenance therapy: 1 to 3 weekly treatments at 6 months following the initiation of treatment, and then every 6 months thereafter until 36 months.
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When administered intravesical-ly as BCG promotes a local acute inflammatory and sub-acute granulomatous reaction with histi-ocytic and leukocytic infiltration in the urothelium and lamina propria of the urinary bladder. The local inflammatory effects are associated with an elimination or reduction of superficial cancerous lesions of the urinary bladder. The antitumor effect appears to be T-lymphocyte-dependent. The exact mechanism by which this is accomplished is unknown, but may involve expression of HLA-DR antigens on bladder urothelium and specific immunity to cells ex-pressing both HLA-DR and BCG antigens on their cell surfaces.
It contains viable attenuated myco-bacteria hence it should be handled with care.
Patients on immunosuppressive therapy; active tuberculosis; previous evidence of a systemic BCG reaction; fever of unknown origin; presence of bacterial UTI; Patients who have had a trans-urethral resection or traumatic bladder catheterization
Local reactions such as transient dysuria and urinary frequency; hematuria; pneumonitis; hepatitis; symptomatic granulomatous prostatitis, epididymo-orchitis, ureteral obstruction, or renal abscess
Drug interactions: Drug combinations containing bone marrow depressants and/or immunosuppressants and/or radiation may impair the response to this drug or increase the risk of disseminated BCG reaction.