Difference between revisions of "Doxorubicin (Adriamycin)"

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==General information==
 
==General information==
Class/mechanism: Anthracycline; binds and intercalates into DNA, inhibiting nucleotide replication and DNA/RNA polymerase activity. Intercalation of DNA triggers DNA cleavage via topoisomerase II. Toxic effects on organs may be related to cell membrane lipid binding activities; enzymatic electron reduction of doxorubicin creates reactive species, e.g. hydroxyl free radicals OH-, which has been implicated in cardiotoxicity by means of Cu (II) and Fe (III) reduction.<ref name="insert">[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Ben+Venue_Bedford+Labs/55390-237-01+ADR+50MG/5539023701 Doxorubicin (Adriamycin) package insert]</ref><ref>[[:File:Doxorubicin.pdf | Doxorubicin (Adriamycin) package insert (locally hosted backup)]]</ref>
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Class/mechanism: Anthracycline; binds and intercalates into DNA, inhibiting nucleotide replication and DNA/RNA polymerase activity. Intercalation of DNA triggers DNA cleavage via topoisomerase II. Toxic effects on organs may be related to cell membrane lipid binding activities; enzymatic electron reduction of doxorubicin creates reactive species, e.g. hydroxyl free radicals OH-, which has been implicated in cardiotoxicity by means of Cu (II) and Fe (III) reduction.<ref name="insert">[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Ben+Venue_Bedford+Labs/55390-237-01+ADR+50MG/5539023701 Doxorubicin (Adriamycin) package insert]</ref><ref>[[:File:Doxorubicin.pdf | Doxorubicin (Adriamycin) 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>  
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 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[Bladder cancer]]
 +
*[[Breast cancer]]
 +
*[[Hepatocellular carcinoma]]
 +
*Non-Hodgkin lymphoma
 +
**[[Diffuse large B-cell lymphoma]]
 +
**[[Follicular lymphoma]]
 +
**[[Mantle cell lymphoma]]
 +
**[[Peripheral T-cell lymphoma]]
 +
*[[Osteosarcoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
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*[[Anaplastic large cell lymphoma]]
 
*[[Anaplastic large cell lymphoma]]
 
*[[B-cell acute lymphoblastic leukemia]]
 
*[[B-cell acute lymphoblastic leukemia]]
*[[Bladder cancer]]
 
*[[Breast cancer]]
 
 
*[[Burkitt lymphoma]]
 
*[[Burkitt lymphoma]]
 
*[[Cutaneous basal cell carcinoma]]
 
*[[Cutaneous basal cell carcinoma]]
 
*[[Cutaneous squamous cell carcinoma]]
 
*[[Cutaneous squamous cell carcinoma]]
*[[Diffuse large B-cell lymphoma]]
 
 
*[[Endometrial cancer]]
 
*[[Endometrial cancer]]
 
*[[Ewing sarcoma]]
 
*[[Ewing sarcoma]]
*[[Follicular lymphoma]]
 
 
*[[Hepatoblastoma]]
 
*[[Hepatoblastoma]]
*[[Hepatocellular carcinoma]]
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*[[High-grade B-cell lymphoma]]
 
*[[HIV-associated lymphoma]]
 
*[[HIV-associated lymphoma]]
*[[Hodgkin lymphoma]]
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*[[Classical Hodgkin lymphoma]]
 
*[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
 
*[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
 
*[[Kaposi sarcoma]]
 
*[[Kaposi sarcoma]]
 
*[[Malignant pleural mesothelioma]]
 
*[[Malignant pleural mesothelioma]]
*[[Mantle cell lymphoma]]
 
 
*[[Marginal zone lymphoma]]
 
*[[Marginal zone lymphoma]]
 
*[[Mediastinal gray-zone lymphoma]]
 
*[[Mediastinal gray-zone lymphoma]]
 
*[[Multiple myeloma]]
 
*[[Multiple myeloma]]
 
*[[Neuroblastoma]]
 
*[[Neuroblastoma]]
*[[Osteosarcoma]]
 
 
*[[Pancreatic NET]]
 
*[[Pancreatic NET]]
*[[Peripheral T-cell lymphoma]]
 
 
*[[Post-transplant lymphoproliferative disorder]]
 
*[[Post-transplant lymphoproliferative disorder]]
 
*[[Primary mediastinal B-cell lymphoma]]
 
*[[Primary mediastinal B-cell lymphoma]]
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*[[Thymoma]]
 
*[[Thymoma]]
 
*[[Transformed lymphoma]]
 
*[[Transformed lymphoma]]
*[[Transplant conditioning regimens]]
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*[[Urothelial carcinoma]]
 
*[[Waldenström macroglobulinemia]]
 
*[[Waldenström macroglobulinemia]]
 
</div>
 
</div>
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==Patient drug information==
 
==Patient drug information==
*[https://chemocare.com/chemotherapy/drug-info/doxorubicin.aspx Doxorubicin (Adriamycin) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/doxorubicin.aspx Doxorubicin (Adriamycin) patient drug information (Chemocare)]</ref>
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*[https://chemocare.com/druginfo/doxorubicin.aspx Doxorubicin (Adriamycin) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/doxorubicin.aspx Doxorubicin (Adriamycin) patient drug information (Chemocare)]</ref>
 
*[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Ben+Venue_Bedford+Labs/55390-237-01+ADR+50MG/5539023701 Doxorubicin (Adriamycin) package insert page 1]<ref name="insert"></ref>  
 
*[http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Ben+Venue_Bedford+Labs/55390-237-01+ADR+50MG/5539023701 Doxorubicin (Adriamycin) package insert page 1]<ref name="insert"></ref>  
 
*[http://www.uptodate.com/contents/doxorubicin-patient-drug-information Doxorubicin (Adriamycin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/doxorubicin-patient-drug-information Doxorubicin (Adriamycin) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/doxorubicin-patient-drug-information Doxorubicin (Adriamycin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/doxorubicin-patient-drug-information Doxorubicin (Adriamycin) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
* 8/7/1974: Initial FDA approval
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* 1974-08-07: Initial FDA approval
* 5/8/2003: Earliest date with label information at Drugs @ FDA: "Doxorubicin has been used successfully to produce regression in disseminated neoplastic conditions such as [[Acute lymphocytic leukemia | acute lymphoblastic leukemia]], [[Acute myeloid leukemia | acute myeloblastic leukemia]], Wilms’ tumor, neuroblastoma, [[Soft tissue sarcoma | soft tissue and bone sarcomas]], [[Breast cancer | breast carcinoma]], [[Ovarian cancer | ovarian carcinoma]], [[Bladder cancer | transitional cell bladder carcinoma]], [[Thyroid cancer | thyroid carcinoma]], [[Gastric cancer | gastric carcinoma]], [[Hodgkin lymphoma | Hodgkin’s disease]], malignant lymphoma and bronchogenic carcinoma in which the [[Small cell lung cancer | small cell histologic type]] is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary [[Breast cancer | breast cancer]].
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* 2003-05-08: Earliest date with label information at Drugs @ FDA: "Doxorubicin has been used successfully to produce regression in disseminated neoplastic conditions such as [[Acute lymphocytic leukemia | acute lymphoblastic leukemia]], [[Acute myeloid leukemia | acute myeloblastic leukemia]], Wilms’ tumor, neuroblastoma, [[Soft tissue sarcoma | soft tissue and bone sarcomas]], [[Breast cancer | breast carcinoma]], [[Ovarian cancer | ovarian carcinoma]], [[Bladder cancer | transitional cell bladder carcinoma]], [[Thyroid cancer | thyroid carcinoma]], [[Gastric cancer | gastric carcinoma]], [[Classical Hodgkin lymphoma | Hodgkin’s disease]], malignant lymphoma and bronchogenic carcinoma in which the [[Small cell lung cancer | small cell histologic type]] is the most responsive compared to other cell types. ''(No supporting studies are cited)''
 
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* Uncertain date: Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary [[Breast cancer | breast cancer]]. ''(Based on EBCTCG 1998 meta-analysis)''
 +
==History of changes in EMA indication==
 +
*1996-06-21: EURD
 +
==History of changes in PMDA indication==
 +
*2014-12-18: Revised indication and a new dosage for the relief of symptoms of [[:Category:Lymphomas|malignant lymphoma]].
 
==Also known as==
 
==Also known as==
 
*'''Code name:''' FI-106
 
*'''Code name:''' FI-106
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|Ifadox
 
|Ifadox
 
|Kemodoxa
 
|Kemodoxa
|Lipodox
+
|Lyphidox
 
|-
 
|-
|Lyphidox
 
 
|Nagun
 
|Nagun
 
|Neoxane
 
|Neoxane
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|Onkostatil
 
|Onkostatil
 
|Pallagicin
 
|Pallagicin
 +
|Ranxas
 
|-
 
|-
|Ranxas
 
 
|Rastocin
 
|Rastocin
 
|Ribodoxo
 
|Ribodoxo
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==References==
 
==References==
 
<references/>
 
<references/>
 +
#Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42. [https://doi.org/10.1016/S0140-6736(98)03301-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9752815/ PubMed]
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
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[[Category:Anthracyclines]]
 
[[Category:Anthracyclines]]
[[Category:Topoisomerase inhibitors]]
+
[[Category:Topoisomerase II inhibitors]]
  
 
[[Category:Adrenocortical carcinoma medications]]
 
[[Category:Adrenocortical carcinoma medications]]
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[[Category:Hepatoblastoma medications]]
 
[[Category:Hepatoblastoma medications]]
 
[[Category:Hepatocellular carcinoma medications]]
 
[[Category:Hepatocellular carcinoma medications]]
 +
[[Category:High-grade B-cell lymphoma medications]]
 
[[Category:HIV-associated lymphoma medications]]
 
[[Category:HIV-associated lymphoma medications]]
[[Category:Hodgkin lymphoma medications]]
+
[[Category:Classical Hodgkin lymphoma medications]]
 
[[Category:Hodgkin lymphoma, nodular lymphocyte-predominant medications]]
 
[[Category:Hodgkin lymphoma, nodular lymphocyte-predominant medications]]
 
[[Category:Kaposi sarcoma medications]]
 
[[Category:Kaposi sarcoma medications]]
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[[Category:Thymoma medications]]
 
[[Category:Thymoma medications]]
 
[[Category:Transformed lymphoma medications]]
 
[[Category:Transformed lymphoma medications]]
 +
[[Category:Urothelial carcinoma medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
  
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[[Category:FDA approved in 1974]]
 
[[Category:FDA approved in 1974]]
 +
[[Category:EMA approved in 1996]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Revision as of 21:57, 20 December 2023

General information

Class/mechanism: Anthracycline; binds and intercalates into DNA, inhibiting nucleotide replication and DNA/RNA polymerase activity. Intercalation of DNA triggers DNA cleavage via topoisomerase II. Toxic effects on organs may be related to cell membrane lipid binding activities; enzymatic electron reduction of doxorubicin creates reactive species, e.g. hydroxyl free radicals OH-, which has been implicated in cardiotoxicity by means of Cu (II) and Fe (III) reduction.[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 established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 1996-06-21: EURD

History of changes in PMDA indication

  • 2014-12-18: Revised indication and a new dosage for the relief of symptoms of malignant lymphoma.

Also known as

  • Code name: FI-106
  • Generic names: ADM, doxorubicin hydrochloride, hydroxydaunorubicin
  • Brand names:
Synonyms
Adriablastina Adriacept Adriacin Adriamycin Adriamycine Adriblastin Adriblastina Adriblastine
Adricept Adricin Adrim Adrimedac Adrosal Antraciclin Biorrub Biorubina
Cadria Carcinocin Cloridrato DE Doxorrubicina Colhidrol Deldoxin Dicladox Dobicin Dobixin
Doxo Doxobin Doxo Cell Doxocris Doxokebir Doxolem Doxonolver Doxor
Doxorrubicina Doxoruben Doxorubicina Doxorubicine Doxorubicinum Doxorubin Doxotec Doxtie
Duxocin Evacet Farmiblastina Fauldoxo Flavicina Ifadox Kemodoxa Lyphidox
Nagun Neoxane Nuaze Oncodria Onkodox Onkostatil Pallagicin Ranxas
Rastocin Ribodoxo Roxorin Rubex Varidoxo Zodox

References

  1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42. link to original article PubMed