BCG vaccine

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.
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.

Diseases for which it is used

• Bladder cancer (intravesicular use)

Diseases for which it was used

• B-cell acute lymphoblastic leukemia
• Breast cancer
• Colon cancer
• Diffuse large B-cell lymphoma
• Hodgkin lymphoma
• Melanoma
• Non-small cell lung cancer

Patient drug information

• Bacillus Calmette-Guérin (BCG) package insert
• Bacillus Calmette-Guérin (BCG) patient drug information (Chemocare)
• Patient information about bladder cancer treatment, including BCG (UpToDate)

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