Difference between revisions of "BCG vaccine"

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==General information==
 
==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.<ref name="insert">[https://www.fda.gov/media/76396/download Bacillus Calmette-Guérin (BCG) package insert]</ref><ref>[[Media: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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==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Bladder cancer]] (intravesicular use)
 
*[[Bladder cancer]] (intravesicular use)
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 +
==Diseases for which it was used==
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*[[B-cell acute lymphoblastic leukemia - historical|B-cell acute lymphoblastic leukemia]]
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*[[Breast cancer - historical|Breast cancer]]
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*[[Colon cancer - historical|Colon cancer]]
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*[[Diffuse large B-cell lymphoma - historical|Diffuse large B-cell lymphoma]]
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*[[Classical Hodgkin lymphoma - historical|Hodgkin lymphoma]]
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*[[Melanoma - historical|Melanoma]]
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*[[Non-small cell lung cancer - historical|Non-small cell lung cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
*[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a83f0b99-9038-4c5a-aaac-8792b32838fe 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]
*[http://chemocare.com/chemotherapy/drug-info/bcg.aspx Bacillus Calmette-Guérin (BCG) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/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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==History of changes in FDA indication==
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*1990-05-22: Initial approval for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder
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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)''
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==History of changes in EMA indication==
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*1988-03-02: EURD
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 +
==History of changes in Health Canada indication==
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*1994-09-08: Initial notice of compliance
 
==Also known as==
 
==Also known as==
 
*'''Generic name:''' Bacille Calmette–Guérin
 
*'''Generic name:''' Bacille Calmette–Guérin
*'''Brand names:''' TheraCys, TICE BCG
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*'''Brand names:''' ImmuCyst, OncoTice, TheraCys, TICE BCG
  
 
==References==
 
==References==
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[[Category:Bladder cancer medications]]
 
[[Category:Bladder cancer medications]]
  
[[Category:FDA approved drugs]]
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*[[Category:B-cell acute lymphoblastic leukemia medications (historic)]]
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*[[Category:Breast cancer medications (historic)]]
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*[[Category:Colon cancer medications (historic)]]
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*[[Category:Diffuse large B-cell lymphoma medications (historic)]]
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*[[Category:Classical Hodgkin lymphoma medications (historic)]]
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*[[Category:Melanoma medications (historic)]]
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*[[Category:Non-small cell lung cancer medications (historic)]]
 +
 
 +
[[Category:FDA approved in 1990]]
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[[Category:EMA approved in 1988]]
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[[Category:Health Canada approved in 1994]]

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