Bacillus Calmette-Guérin (BCG)

General information

Class/mechanism: Live mycobacteria which promote a local acute inflammatory and sub-acute granulomatous reaction with macrophage and leukocyte infiltration in the urothelium and lamina propria of the urinary bladder. This results in a likely T-lymphocyte dependent anti-tumor effect.^[1]^[2]
Route: Intravesicular
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Bladder cancer (intravesicular use)

Diseases for which it was used

Patient drug information

History of changes in FDA indication

1990-05-22: Initial approval for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder
1990-05-22: Initial approval for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). (Based on SWOG 8216 & SWOG 8507)

History of changes in EMA indication

EURD: 1988-03-02

History of changes in Health Canada indication

1994-09-08: Initial notice of compliance

Also known as

Generic name: Bacille Calmette–Guérin
Brand names: TheraCys, TICE BCG

References

[insert-1] 1.0 ^1.1 Bacillus Calmette-Guérin (BCG) package insert

[2] Bacillus Calmette-Guérin (BCG) package insert (locally hosted backup)

[3] Bacillus Calmette-Guérin (BCG) patient information (Chemocare)

[4] Patient information about bladder cancer treatment, including BCG (UpToDate)

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