Bacillus Calmette-Guerin (BCG), Live Intravesical — Drug Monograph
Brand names: TICE BCG, TheraCys
Drug class: Other
Mechanism of Action
Live attenuated strain of Mycobacterium bovis instilled into the bladder. It provokes a robust local immune/inflammatory response — attachment to the urothelium, uptake by tumor and immune cells, and recruitment of T cells, macrophages, and cytokines — resulting in a nonspecific immunotherapeutic antitumor effect against non-muscle-invasive bladder cancer. Precise mechanism is not fully defined but is immune-mediated rather than directly cytotoxic.
FDA Indications
- Non-muscle-invasive bladder cancer — treatment and prophylaxis of carcinoma in situ (CIS) and prophylaxis of primary or recurrent stage Ta/T1 papillary tumors following transurethral resection (TURBT)
Common Side Effects
- Dysuria
- Urinary frequency/urgency
- Hematuria
- Cystitis
- Malaise/fatigue
- Low-grade fever
- Flu-like symptoms
Clinical Pearl
Intravesical BCG remains the standard of care for high-risk non-muscle-invasive bladder cancer and CIS. Never instill after traumatic catheterization or with gross hematuria — systemic absorption can cause life-threatening BCG sepsis. Suspected disseminated BCG infection is treated with multidrug antituberculous therapy (BCG is inherently resistant to pyrazinamide).