Difference between revisions of "Doxorubicin (Adriamycin)"

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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: 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>[[Media:Doxorubicin.pdf | Doxorubicin (Adriamycin) package insert (locally hosted backup)]]</ref>
+
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 or the prescribing information.<ref name="insert"></ref>  
  
==Diseases for which it is used==
+
==Diseases for which it is established ''(work in progress)''==
*[[Acute lymphocytic leukemia]]
 
*[[Aggressive Non-Hodgkin lymphoma]]
 
*[[Basal cell and squamous cell skin cancer]]
 
 
*[[Bladder cancer]]
 
*[[Bladder cancer]]
*[[Bone cancer]]
 
 
*[[Breast cancer]]
 
*[[Breast cancer]]
*[[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)]]
+
*[[Hepatocellular carcinoma]]
*[[Follicular lymphoma]]
+
*Non-Hodgkin lymphoma
*[[Hepatobiliary cancer]]
+
**[[Diffuse large B-cell lymphoma]]
 +
**[[Follicular lymphoma]]
 +
**[[Mantle cell lymphoma]]
 +
**[[Peripheral T-cell lymphoma]]
 +
*[[Osteosarcoma]]
 +
 
 +
==Diseases for which it is used==
 +
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
 +
*[[Adrenocortical carcinoma]]
 +
*[[Adult T-cell leukemia-lymphoma]]
 +
*[[Anaplastic large cell lymphoma]]
 +
*[[B-cell acute lymphoblastic leukemia]]
 +
*[[Burkitt lymphoma]]
 +
*[[Cutaneous basal cell carcinoma]]
 +
*[[Cutaneous squamous cell carcinoma]]
 +
*[[Endometrial cancer]]
 +
*[[Ewing sarcoma]]
 +
*[[Hepatoblastoma]]
 +
*[[High-grade B-cell lymphoma]]
 
*[[HIV-associated lymphoma]]
 
*[[HIV-associated lymphoma]]
*[[Hodgkin lymphoma]]
+
*[[Classical Hodgkin lymphoma]]
 
*[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
 
*[[Hodgkin lymphoma, nodular lymphocyte-predominant]]
*[[Mantle cell lymphoma]]
+
*[[Kaposi sarcoma]]
 +
*[[Malignant pleural mesothelioma]]
 
*[[Marginal zone lymphoma]]
 
*[[Marginal zone lymphoma]]
 +
*[[Mediastinal gray-zone lymphoma]]
 
*[[Multiple myeloma]]
 
*[[Multiple myeloma]]
*[[Neuroendocrine tumors]]
+
*[[Neuroblastoma]]
*[[Renal cancer]]
+
*[[Pancreatic NET]]
*[[Sarcoma]]
+
*[[Post-transplant lymphoproliferative disorder]]
*[[Small cell lung cancer]]
+
*[[Primary mediastinal B-cell lymphoma]]
*[[T-cell lymphoma]]
+
*[[Rhabdomyosarcoma]]
 +
*[[Sarcomatoid renal cell carcinoma]]
 +
*[[Soft tissue sarcoma]]
 
*[[Thymoma]]
 
*[[Thymoma]]
*[[Transplant conditioning regimens]]
+
*[[Transformed lymphoma]]
*[[Uterine cancer]]
+
*[[Urothelial carcinoma]]
 +
*[[Waldenström macroglobulinemia]]
 +
</div>
 +
 
 +
==Diseases for which it was used==
 +
*[[Acute myeloid leukemia - historical|Acute myeloid leukemia]]
 +
*[[Chronic lymphocytic leukemia - historical|Chronic lymphocytic leukemia]]
 +
*[[Gastric cancer - historical|Gastric cancer]]
 +
*[[Non-small cell lung cancer - historical|Non-small cell lung cancer]]
 +
*[[Ovarian cancer - historical|Ovarian cancer]]
 +
*[[Prostate cancer - historical|Prostate cancer]]
 +
*[[Small cell lung cancer - historical|Small cell lung cancer]]
 +
*[[Testicular cancer - historical|Testicular cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
*[http://chemocare.com/chemotherapy/drug-info/doxorubicin.aspx Doxorubicin (Adriamycin) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/doxorubicin.aspx Doxorubicin (Adriamycin) patient drug information (Chemocare)]</ref>
+
*[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
+
* 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, [[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]].
+
* 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)''
 
+
* 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==
{| border="1" style="text-align:center;"
+
*'''Code name:''' FI-106
 +
*'''Generic names:''' ADM, doxorubicin hydrochloride, hydroxydaunorubicin
 +
*'''Brand names:'''
 +
{| class="wikitable" style="text-align:center;"
 
!colspan="8" align="center" style="background-color:#0066FF"| '''Synonyms'''
 
!colspan="8" align="center" style="background-color:#0066FF"| '''Synonyms'''
 
|-
 
|-
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|Adriacept
 
|Adriacept
 
|Adriacin
 
|Adriacin
|Adriamycin HS
+
|Adriamycin
|Adriamycin PFS
+
|Adriamycine
|Adriamycin R-D
 
|Adriamycin R.D.F
 
|Adriamycin RDF
 
|-
 
 
|Adriblastin
 
|Adriblastin
 
|Adriblastina
 
|Adriblastina
|Adriblastina DR
 
|Adriblastina R.D.
 
|Adriblastina R.T.U.
 
|Adriblastina RD
 
|Adriblastina RTU
 
 
|Adriblastine
 
|Adriblastine
 
|-
 
|-
|Adriblastine RTU
 
|Adriblastin PFS
 
|Adriblastin RD
 
 
|Adricept
 
|Adricept
 
|Adricin
 
|Adricin
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|Adrimedac
 
|Adrimedac
 
|Adrosal
 
|Adrosal
|-
 
 
|Antraciclin
 
|Antraciclin
 
|Biorrub
 
|Biorrub
 
|Biorubina
 
|Biorubina
 +
|-
 
|Cadria
 
|Cadria
 
|Carcinocin
 
|Carcinocin
 
|Cloridrato DE
 
|Cloridrato DE
 
|Doxorrubicina Colhidrol
 
|Doxorrubicina Colhidrol
|Daxotel
 
|-
 
 
|Deldoxin
 
|Deldoxin
 
|Dicladox
 
|Dicladox
 
|Dobicin
 
|Dobicin
 
|Dobixin
 
|Dobixin
 +
|-
 
|Doxo
 
|Doxo
 
|Doxobin
 
|Doxobin
 
|Doxo Cell
 
|Doxo Cell
 
|Doxocris
 
|Doxocris
|-
 
 
|Doxokebir
 
|Doxokebir
 
|Doxolem
 
|Doxolem
|Doxolem RU
 
 
|Doxonolver
 
|Doxonolver
 
|Doxor
 
|Doxor
 +
|-
 
|Doxorrubicina
 
|Doxorrubicina
 
|Doxoruben
 
|Doxoruben
 
|Doxorubicina
 
|Doxorubicina
|-
 
|Doxorubicina Asofarma
 
|Doxorubicina Ferrer
 
|Doxorubicina Filaxis
 
|Doxorubicina Gador
 
|Doxorubicina Servycal
 
|Doxorubicina Tedec
 
|Doxorubicin Bigmar
 
|Doxorubicin Comp
 
|-
 
|Doxorubicin DBL
 
 
|Doxorubicine
 
|Doxorubicine
|Doxorubicin Ebewe
 
|Doxorubicine Bristol
 
|Doxorubicine Dakota
 
|Doxorubicine G GAM
 
|Doxorubicine HCl Eurocept
 
|Doxorubicine Hydrochloride
 
|-
 
|Doxorubicine Sandoz HCl
 
|Doxorubicine Teva
 
|Doxorubicin FOT
 
|Doxorubicin Funk
 
|Doxorubicin HCl
 
|Doxorubicin Hydrochloride
 
|Doxorubicin KMP
 
|Doxorubicin Meda
 
|-
 
|Doxorubicin Pharmachemie
 
|Doxorubicin Teva
 
 
|Doxorubicinum
 
|Doxorubicinum
 
|Doxorubin
 
|Doxorubin
 
|Doxotec
 
|Doxotec
 
|Doxtie
 
|Doxtie
 +
|-
 
|Duxocin
 
|Duxocin
 
|Evacet
 
|Evacet
|-
 
 
|Farmiblastina
 
|Farmiblastina
 
|Fauldoxo
 
|Fauldoxo
 
|Flavicina
 
|Flavicina
|hydroxydaunorubicin
+
|Ifadox
|Ifadox,L-Doxorubicin
+
|Kemodoxa
|Lipodox
 
 
|Lyphidox
 
|Lyphidox
|Myocet
 
 
|-
 
|-
 
|Nagun
 
|Nagun
Line 154: Line 146:
 
|Rastocin
 
|Rastocin
 
|Ribodoxo
 
|Ribodoxo
|Ribodoxo-L
 
 
|Roxorin
 
|Roxorin
 
|Rubex
 
|Rubex
|Trav Doxorubicin
 
|Urokit Doxo Cell Loesung
 
 
|Varidoxo
 
|Varidoxo
|-
 
 
|Zodox
 
|Zodox
 
|}
 
|}
Line 166: Line 154:
 
==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:Intra-arterial medications]]
 +
[[Category:Intravenous medications]]
 +
[[Category:Intravesical medications]]
 +
[[Category:Vesicant]]
  
[[Category:Drug index]]
 
[[Category:Chemotherapy]]
 
 
[[Category:Anthracyclines]]
 
[[Category:Anthracyclines]]
[[Category:Topoisomerase inhibitors]]
+
[[Category:Topoisomerase II inhibitors]]
[[Category:Vesicant chemotherapy]]
 
  
[[Category:Acute lymphocytic leukemia medications]]
+
[[Category:Adrenocortical carcinoma medications]]
[[Category:Aggressive Non-Hodgkin lymphoma medications]]
+
[[Category:Adult T-cell leukemia-lymphoma medications]]
[[Category:Basal cell and squamous cell skin cancer medications]]
+
[[Category:Anaplastic large cell lymphoma medications]]
 +
[[Category:B-cell acute lymphoblastic leukemia medications]]
 
[[Category:Bladder cancer medications]]
 
[[Category:Bladder cancer medications]]
[[Category:Bone cancer medications]]
 
 
[[Category:Breast cancer medications]]
 
[[Category:Breast cancer medications]]
[[Category:Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) medications]]
+
[[Category:Burkitt lymphoma medications]]
 +
[[Category:Cutaneous basal cell carcinoma medications]]
 +
[[Category:Cutaneous squamous cell carcinoma medications]]
 +
[[Category:Diffuse large B-cell lymphoma medications]]
 +
[[Category:Endometrial cancer medications]]
 +
[[Category:Ewing sarcoma medications]]  
 
[[Category:Follicular lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
[[Category:Hepatobiliary cancer medications]]
+
[[Category:Hepatoblastoma 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:Malignant pleural mesothelioma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Marginal zone lymphoma medications]]
 
[[Category:Marginal zone lymphoma medications]]
 +
[[Category:Mediastinal gray-zone lymphoma medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
[[Category:Neuroendocrine tumor medications]]
+
[[Category:Neuroblastoma medications]]
[[Category:Renal cancer medications]]
+
[[Category:Osteosarcoma medications]]
[[Category:Sarcoma medications]]
+
[[Category:Pancreatic NET medications]]
[[Category:Small cell lung cancer medications]]
+
[[Category:Peripheral T-cell lymphoma medications]]
[[Category:T-cell lymphoma medications]]
+
[[Category:Post-transplant lymphoproliferative disorder medications]]
 +
[[Category:Primary mediastinal B-cell lymphoma medications]]
 +
[[Category:Rhabdomyosarcoma medications]]
 +
[[Category:Sarcomatoid renal cell carcinoma medications]]
 +
[[Category:Soft tissue sarcoma medications]]
 
[[Category:Thymoma medications]]
 
[[Category:Thymoma medications]]
[[Category:Transplant medications]]
+
[[Category:Transformed lymphoma medications]]
[[Category:Uterine cancer medications]]
+
[[Category:Urothelial carcinoma medications]]
 +
[[Category:Waldenström macroglobulinemia medications]]
 +
 
 +
*[[Category:Acute myeloid leukemia medications (historic)]]
 +
*[[Category:Chronic lymphocytic leukemia medications (historic)]]
 +
*[[Category:Gastric cancer medications (historic)]]
 +
*[[Category:Non-small cell lung cancer medications (historic)]]
 +
*[[Category:Ovarian cancer medications (historic)]]
 +
*[[Category:Prostate cancer medications (historic)]]
 +
*[[Category:Small cell lung cancer medications (historic)]]
 +
*[[Category:Testicular cancer medications (historic)]]
  
[[Category:Drugs FDA approved in 1974]]
+
[[Category:FDA approved in 1974]]
 +
[[Category:EMA approved in 1996]]
 +
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 01:00, 29 June 2024

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 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