Difference between revisions of "Dactinomycin (Cosmegen)"

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m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information")
 
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==General information==
 
==General information==
−
Class/mechanism: Antibiotic oncologic, intercalates between guanine and cytosine DNA base pairs, inhibiting DNA and RNA synthesis.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf Dactinomycin (Cosmegen) package insert]</ref><ref>[[:File:Dactinomycin.pdf | Dactinomycin (Cosmegen) package insert (locally hosted backup)]]</ref>
+
Class/mechanism: Antibiotic oncologic, intercalates between guanine and cytosine DNA base pairs, inhibiting DNA and RNA synthesis.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf Dactinomycin (Cosmegen) package insert]</ref><ref>[[:File:Dactinomycin.pdf | Dactinomycin (Cosmegen) package insert (locally hosted backup)]]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: [[vesicant]]
 
<br>Extravasation: [[vesicant]]
  
−
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
+
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 or the prescribing information.<ref name="insert"></ref>  
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
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==Patient drug information==
 
==Patient drug information==
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*[https://chemocare.com/chemotherapy/drug-info/dactinomycin.aspx Dactinomycin (Cosmegen) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/dactinomycin.aspx Dactinomycin (Cosmegen) patient drug information (Chemocare)]</ref>
+
*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf Dactinomycin (Cosmegen) package insert]<ref name="insert"></ref>
 +
*[https://chemocare.com/druginfo/dactinomycin.aspx Dactinomycin (Cosmegen) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/dactinomycin.aspx Dactinomycin (Cosmegen) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/dactinomycin-patient-drug-information Dactinomycin (Cosmegen) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/dactinomycin-patient-drug-information Dactinomycin (Cosmegen) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/dactinomycin-patient-drug-information Dactinomycin (Cosmegen) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/dactinomycin-patient-drug-information Dactinomycin (Cosmegen) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 12/10/1964: Initial FDA approval
+
*1964-12-10: Initial FDA approval
−
* 3/13/2009 (earliest label available at Drugs@FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of [[Wilms tumor]]. ''(Based on NWTS-1, NWTS-2, NWTS-3, NWTS-4)''
+
*2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of [[Wilms tumor]]. ''(Based on NWTS-1, NWTS-2, NWTS-3, NWTS-4)''
−
* 3/13/2009 (earliest label available at Drugs@FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of childhood [[rhabdomyosarcoma]]. ''(Based on IRS-III)''
+
* 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of childhood [[rhabdomyosarcoma]]. ''(Based on IRS-III)''
−
* 3/13/2009 (earliest label available at Drugs@FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of [[Ewing sarcoma]]. ''(Based on ET-1)''
+
* 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of [[Ewing sarcoma]]. ''(Based on ET-1)''
−
* 3/13/2009 (earliest label available at Drugs@FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of metastatic, nonseminomatous [[testicular cancer]]. ''(Based on Bosl et al. 1986 & Vugrin et al. 1981)''
+
* 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of metastatic, nonseminomatous [[testicular cancer]]. ''(Based on Bosl et al. 1986 & Vugrin et al. 1981)''
−
* 3/13/2009 (earliest label available at Drugs@FDA): Approved as a single agent, or as part of a combination chemotherapy regimen, for the treatment of [[gestational trophoblastic neoplasia]]. ''(Based on Osathanondh et al. 1975 & Newlands et al. 1991)''
+
* 2009-03-13 (oldest label available at Drugs @ FDA): Approved as a single agent, or as part of a combination chemotherapy regimen, for the treatment of [[gestational trophoblastic neoplasia]]. ''(Based on Osathanondh et al. 1975 & Newlands et al. 1991)''
−
* 3/13/2009 (earliest label available at Drugs@FDA): Approved as a component of regional perfusion for the palliative and/or adjunctive treatment of locally recurrent or locoregional [[:Category:Malignant solid neoplasm|solid malignancies]].
+
* 2009-03-13 (oldest label available at Drugs @ FDA): Approved as a component of regional perfusion for the palliative and/or adjunctive treatment of locally recurrent or locoregional [[:Category:Malignant solid neoplasm|solid malignancies]].
−
 
+
==History of changes in EMA indication==
 +
*1963-07-01: EURD
 
==Also known as==
 
==Also known as==
 
*'''Generic names:''' AC-DE, actinomycin D
 
*'''Generic names:''' AC-DE, actinomycin D
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[[Category:FDA approved in 1964]]
 
[[Category:FDA approved in 1964]]
 +
[[Category:EMA approved in 1963]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 00:57, 29 June 2024

General information

Class/mechanism: Antibiotic oncologic, intercalates between guanine and cytosine DNA base pairs, inhibiting DNA and RNA synthesis.[1][2]
Route: IV
Extravasation: vesicant

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 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

  • 1964-12-10: Initial FDA approval
  • 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of Wilms tumor. (Based on NWTS-1, NWTS-2, NWTS-3, NWTS-4)
  • 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of childhood rhabdomyosarcoma. (Based on IRS-III)
  • 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of Ewing sarcoma. (Based on ET-1)
  • 2009-03-13 (oldest label available at Drugs @ FDA): Approved as part of a combination chemotherapy and/or multi-modality treatment regimen for the treatment of metastatic, nonseminomatous testicular cancer. (Based on Bosl et al. 1986 & Vugrin et al. 1981)
  • 2009-03-13 (oldest label available at Drugs @ FDA): Approved as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia. (Based on Osathanondh et al. 1975 & Newlands et al. 1991)
  • 2009-03-13 (oldest label available at Drugs @ FDA): Approved as a component of regional perfusion for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

History of changes in EMA indication

  • 1963-07-01: EURD

Also known as

  • Generic names: AC-DE, actinomycin D
  • Brand names: Cosmegen, Dacmozen, Lyovac

References

  1. ↑ 1.0 1.1 1.2 Dactinomycin (Cosmegen) package insert
  2. ↑ Dactinomycin (Cosmegen) package insert (locally hosted backup)
  3. ↑ Dactinomycin (Cosmegen) patient drug information (Chemocare)
  4. ↑ Dactinomycin (Cosmegen) patient drug information (UpToDate)
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