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 | + | 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 | ||
| − | 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 | + | 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, [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://reference.medscape.com/drug/tice-bcg-vaccine-tice-strain-343147 Medscape], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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*[[Colon cancer - historical|Colon cancer]] | *[[Colon cancer - historical|Colon cancer]] | ||
*[[Diffuse large B-cell lymphoma - historical|Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma - historical|Diffuse large B-cell lymphoma]] | ||
| − | *[[Hodgkin lymphoma - historical|Hodgkin lymphoma]] | + | *[[Classical Hodgkin lymphoma - historical|Hodgkin lymphoma]] |
*[[Melanoma - historical|Melanoma]] | *[[Melanoma - historical|Melanoma]] | ||
*[[Non-small cell lung cancer - historical|Non-small cell lung cancer]] | *[[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=c9b74876-e665-442b-87ad-b7333bc9a67a | + | *[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9b74876-e665-442b-87ad-b7333bc9a67a BCG vaccine package insert] |
| − | *[https://chemocare.com/ | + | *[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 treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder | *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 [[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== | ||
| + | *1988-03-02: EURD | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *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 | + | *'''Brand names:''' ImmuCyst, OncoTice, TheraCys, TICE BCG |
==References== | ==References== | ||
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*[[Category:Non-small cell lung cancer medications (historic)]] | *[[Category:Non-small cell lung cancer medications (historic)]] | ||
| − | [[Category:FDA approved | + | [[Category:FDA approved in 1990]] |
| + | [[Category:EMA approved in 1988]] | ||
| + | [[Category:Health Canada approved in 1994]] | ||
Latest revision as of 01:52, 29 June 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, UpToDate Lexidrug, 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
- 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
- BCG vaccine package insert
- BCG vaccine patient drug information (Chemocare)[3]
- Patient information about bladder cancer treatment, including BCG (UpToDate)[4]
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
Categories:
- Drugs
- Intravesical medications
- Immunotherapeutic
- T-cell activators
- Bladder cancer medications
- B-cell acute lymphoblastic leukemia medications (historic)
- Breast cancer medications (historic)
- Colon cancer medications (historic)
- Diffuse large B-cell lymphoma medications (historic)
- Classical Hodgkin lymphoma medications (historic)
- Melanoma medications (historic)
- Non-small cell lung cancer medications (historic)
- FDA approved in 1990
- EMA approved in 1988
- Health Canada approved in 1994