Difference between revisions of "Epirubicin (Ellence)"

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==General information==
 
==General information==
−
Class/mechanism: Anthracycline; binds and intercalates DNA, which triggers DNA cleavage by topoisomerase II; inhibits DNA/RNA synthesis. Inhibits DNA helicase activity, preventing enzymatic separation of double-stranded DNA.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf Epirubicin (Ellence) package insert]</ref><ref>[[Media:Epirubicin.pdf | Epirubicin (Ellence) package insert (locally hosted backup)]]</ref>
+
Class/mechanism: Anthracycline; binds and intercalates DNA, which triggers DNA cleavage by topoisomerase II; inhibits DNA/RNA synthesis. Inhibits DNA helicase activity, preventing enzymatic separation of double-stranded DNA.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf Epirubicin (Ellence) package insert]</ref><ref>[[:File:Epirubicin.pdf | Epirubicin (Ellence) 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 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>  
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[Aggressive Non-Hodgkin lymphoma]]
+
*[[Bladder cancer]]
−
*[[Bone cancer]]
 
 
*[[Breast cancer]]
 
*[[Breast cancer]]
 +
*[[Cholangiocarcinoma]]
 +
*[[Diffuse large B-cell lymphoma]]
 
*[[Esophageal cancer]]
 
*[[Esophageal cancer]]
 +
**[[Esophageal adenocarcinoma]]
 +
*[[Gallbladder cancer]]
 
*[[Gastric cancer]]
 
*[[Gastric cancer]]
−
*[[Hepatobiliary cancer]]
+
*[[Hepatocellular carcinoma]]
−
*[[Sarcoma]]
+
*[[Classical Hodgkin lymphoma]]
 +
*[[Nasopharyngeal carcinoma]]
 +
*[[Osteosarcoma]]
 +
*[[Small cell lung cancer]]
 +
*[[Soft tissue sarcoma]]
 
*[[Testicular cancer]]
 
*[[Testicular cancer]]
 +
 +
==Diseases for which it was used==
 +
*[[Ovarian cancer - historical|Ovarian cancer]]
 +
*[[Pancreatic cancer - historical|Pancreatic cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
−
*[http://chemocare.com/chemotherapy/drug-info/epirubicin.aspx Epirubicin (Ellence) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/epirubicin.aspx Epirubicin (Ellence) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/epirubicin.aspx Epirubicin (Ellence) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/epirubicin.aspx Epirubicin (Ellence) patient drug information (Chemocare)]</ref>
 
*Brief patient counseling information can be found on [http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf#page=15 pages 15-16 of the Epirubicin (Ellence) package insert]<ref name="insert"></ref>
 
*Brief patient counseling information can be found on [http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf#page=15 pages 15-16 of the Epirubicin (Ellence) package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/epirubicin-patient-drug-information Epirubicin (Ellence) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/epirubicin-patient-drug-information Epirubicin (Ellence) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/epirubicin-patient-drug-information Epirubicin (Ellence) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/epirubicin-patient-drug-information Epirubicin (Ellence) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 9/15/1999: Initial FDA approval "as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary [[Breast cancer | breast cancer]]."
+
* 1999-09-15: Initial approval as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary [[breast cancer]]. ''(Based on FASG 05 & NCIC-CTG MA.5)''
−
 
+
==History of changes in EMA indication==
 +
''The approval of this drug pre-dates the EMA.''
 +
*1982-06-28: EURD
 
==Also known as==
 
==Also known as==
−
{| border="1" style="text-align:center;"
+
*'''Generic name:''' 4-epi-doxorubicin, epidoxorubicin
−
!colspan="8" align="center" style="background-color:#0066FF"| '''Synonyms'''
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*'''Brand names:''' Alrubicin, Anthracin, Binarin, Bioepicyna, Crisabon, E.P.R Elvetium, Ellence, Epidoxo, Epifil, Epilem, Epirubicine, Epizin, Epricin, Eracin, Famorubicin, Farmorubicin, Farmorubicina, Farmorubicine, Pharmorubicin, Riboepi, Rubifarm
−
|-
 
−
|Alrubicin
 
−
|Anthracin
 
−
|Binarin
 
−
|Bioepicyna
 
−
|Crisabon
 
−
|-
 
−
|E.P.R Elvetium
 
−
|Ellence
 
−
|EPI
 
−
|EPI Cell
 
−
|Epidoxo
 
−
|-
 
−
|Epifil
 
−
|Epilem
 
−
|Epirubicin
 
−
|Epirubicina Microsules
 
−
|Epirubicine
 
−
|-
 
−
|Epirubicin Ebewe
 
−
|Epirubicine HCl PCH
 
−
|Epirubicin Hexal
 
−
|Epirubicin Hydrochloride
 
−
|Epizin
 
−
|-
 
−
|Epricin
 
−
|Eracin
 
−
|Famorubicin
 
−
|Farmorubicin
 
−
|Farmorubicin-RTU
 
−
|-
 
−
|Farmorubicina
 
−
|Farmorubicina CS
 
−
|Farmorubicina PFS / RTU
 
−
|Farmorubicin CS
 
−
|Farmorubicin DR
 
−
|-
 
−
|Farmorubicine
 
−
|Farmorubicine R.T.U.
 
−
|Farmorubicine RTU
 
−
|Farmorubicin HL
 
−
|Farmorubicin PFS
 
−
|-
 
−
|Farmorubicin RD
 
−
|Farmorubicin Solution
 
−
|Pharmorubicin CS
 
−
|Riboepi
 
−
|Rubifarm
 
−
|-
 
−
|Trav Epirubicin
 
−
|Vero Epirubicin
 
−
|}
 
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
−
[[Category:Chemotherapy]]
+
[[Category:Intravenous medications]]
−
[[Category:Vesicant chemotherapy]]
+
[[Category:Vesicant]]
 +
 
 
[[Category:Anthracyclines]]
 
[[Category:Anthracyclines]]
−
[[Category:Topoisomerase inhibitors]]
+
[[Category:Topoisomerase II inhibitors]]
−
[[Category:DNA synthesis inhibitors]]
+
[[Category:Human DNA synthesis inhibitors]]
  
−
[[Category:Aggressive Non-Hodgkin lymphoma medications]]
+
[[Category:Bladder cancer medications]]
−
[[Category:Bone cancer medications]]  
 
 
[[Category:Breast cancer medications]]
 
[[Category:Breast cancer medications]]
 +
[[Category:Cholangiocarcinoma medications]]
 +
[[Category:Diffuse large B-cell lymphoma medications]]
 +
[[Category:Esophageal adenocarcinoma medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Esophageal cancer medications]]
 +
[[Category:Gallbladder cancer medications]]
 
[[Category:Gastric cancer medications]]
 
[[Category:Gastric cancer medications]]
−
[[Category:Hepatobiliary cancer medications]]
+
[[Category:Hepatocellular carcinoma medications]]
−
[[Category:Sarcoma medications]]  
+
[[Category:Classical Hodgkin lymphoma medications]]
 +
[[Category:Nasopharyngeal carcinoma medications]]
 +
[[Category:Osteosarcoma medications]]
 +
[[Category:Small cell lung cancer medications]]
 +
[[Category:Soft tissue sarcoma medications]]  
 
[[Category:Testicular cancer medications]]
 
[[Category:Testicular cancer medications]]
  
−
[[Category:Drugs FDA approved in 1999]]
+
[[Category:Ovarian cancer medications (historic)]]
 +
[[Category:Pancreatic cancer medications (historic)]]
 +
 
 +
[[Category:FDA approved in 1999]]
 +
[[Category:EMA approved in 1982]]

Revision as of 14:13, 29 December 2023

General information

Class/mechanism: Anthracycline; binds and intercalates DNA, which triggers DNA cleavage by topoisomerase II; inhibits DNA/RNA synthesis. Inhibits DNA helicase activity, preventing enzymatic separation of double-stranded DNA.[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 such as Micromedex, Lexicomp, 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

  • 1999-09-15: Initial approval as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. (Based on FASG 05 & NCIC-CTG MA.5)

History of changes in EMA indication

The approval of this drug pre-dates the EMA.

  • 1982-06-28: EURD

Also known as

  • Generic name: 4-epi-doxorubicin, epidoxorubicin
  • Brand names: Alrubicin, Anthracin, Binarin, Bioepicyna, Crisabon, E.P.R Elvetium, Ellence, Epidoxo, Epifil, Epilem, Epirubicine, Epizin, Epricin, Eracin, Famorubicin, Farmorubicin, Farmorubicina, Farmorubicine, Pharmorubicin, Riboepi, Rubifarm

References

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