Difference between revisions of "BCG vaccine"

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m (Text replacement - "chemocare.com/chemotherapy/drug-info" to "chemocare.com/druginfo")
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==General information==
 
==General information==
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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.<ref name="insert">[https://www.fda.gov/media/76396/download Bacillus Calmette-Guérin (BCG) package insert]</ref><ref>[[:File:Bacilluscalmetteguerin.pdf | Bacillus Calmette-Guérin (BCG) package insert (locally hosted backup)]]</ref>
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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.<ref name="insert">[https://www.fda.gov/media/76396/download BCG vaccine package insert]</ref><ref>[[:File:Bacilluscalmetteguerin.pdf | BCG vaccine package insert (locally hosted backup)]]</ref>
 
<br>Route: Intravesicular
 
<br>Route: Intravesicular
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
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==Patient drug information==
 
==Patient drug information==
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*[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9b74876-e665-442b-87ad-b7333bc9a67a Bacillus Calmette-Guérin (BCG) package insert]
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*[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9b74876-e665-442b-87ad-b7333bc9a67a BCG vaccine package insert]
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*[https://chemocare.com/druginfo/bcg.aspx Bacillus Calmette-Guérin (BCG) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/bcg.aspx Bacillus Calmette-Guérin (BCG) patient information (Chemocare)]</ref>
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*[https://chemocare.com/druginfo/bcg.aspx BCG vaccine patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/bcg.aspx BCG vaccine patient information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/patient-information-bladder-cancer-treatment-non-muscle-invasive-superficial-cancer Patient information about bladder cancer treatment, including BCG (UpToDate)]<ref>[http://www.uptodate.com/contents/patient-information-bladder-cancer-treatment-non-muscle-invasive-superficial-cancer Patient information about bladder cancer treatment, including BCG (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/patient-information-bladder-cancer-treatment-non-muscle-invasive-superficial-cancer Patient information about bladder cancer treatment, including BCG (UpToDate)]<ref>[http://www.uptodate.com/contents/patient-information-bladder-cancer-treatment-non-muscle-invasive-superficial-cancer Patient information about bladder cancer treatment, including BCG (UpToDate)]</ref>
  
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*1990-05-22: Initial approval for the prophylaxis of primary or recurrent stage Ta and/or T1 [[bladder cancer|papillary tumors]] following transurethral resection (TUR). ''(Based on SWOG 8216 & SWOG 8507)''
 
*1990-05-22: Initial approval for the prophylaxis of primary or recurrent stage Ta and/or T1 [[bladder cancer|papillary tumors]] following transurethral resection (TUR). ''(Based on SWOG 8216 & SWOG 8507)''
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
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*EURD: 1988-03-02
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*1988-03-02: EURD
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==History of changes in Health Canada indication==
 
==History of changes in Health Canada indication==
 
*1994-09-08: Initial notice of compliance
 
*1994-09-08: Initial notice of compliance
 
==Also known as==
 
==Also known as==
 
*'''Generic name:''' Bacille Calmette–Guérin
 
*'''Generic name:''' Bacille Calmette–Guérin
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*'''Brand names:''' TheraCys, TICE BCG
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*'''Brand names:''' ImmuCyst, OncoTice, TheraCys, TICE BCG
  
 
==References==
 
==References==

Revision as of 01:39, 30 March 2024

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

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

  • 1988-03-02: EURD

History of changes in Health Canada indication

  • 1994-09-08: Initial notice of compliance

Also known as

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

References

  1. ↑ 1.0 1.1 BCG vaccine package insert
  2. ↑ BCG vaccine package insert (locally hosted backup)
  3. ↑ BCG vaccine patient information (Chemocare)
  4. ↑ Patient information about bladder cancer treatment, including BCG (UpToDate)
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