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. | + | 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> | ||
| + | |||
| + | ==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== | ||
| Line 12: | Line 23: | ||
*[[Anaplastic large cell lymphoma]] | *[[Anaplastic large cell lymphoma]] | ||
*[[B-cell acute lymphoblastic leukemia]] | *[[B-cell acute lymphoblastic leukemia]] | ||
| + | *[[Burkitt lymphoma]] | ||
*[[Cutaneous basal cell carcinoma]] | *[[Cutaneous basal cell carcinoma]] | ||
| − | *[[ | + | *[[Cutaneous squamous cell carcinoma]] |
| − | *[[ | + | *[[Endometrial cancer]] |
| − | |||
| − | |||
| − | |||
*[[Ewing sarcoma]] | *[[Ewing sarcoma]] | ||
| − | |||
*[[Hepatoblastoma]] | *[[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]] | ||
*[[Kaposi sarcoma]] | *[[Kaposi sarcoma]] | ||
| − | *[[ | + | *[[Malignant pleural mesothelioma]] |
*[[Marginal zone lymphoma]] | *[[Marginal zone lymphoma]] | ||
*[[Mediastinal gray-zone lymphoma]] | *[[Mediastinal gray-zone lymphoma]] | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
| − | *[[ | + | *[[Neuroblastoma]] |
*[[Pancreatic NET]] | *[[Pancreatic NET]] | ||
| − | |||
*[[Post-transplant lymphoproliferative disorder]] | *[[Post-transplant lymphoproliferative disorder]] | ||
*[[Primary mediastinal B-cell lymphoma]] | *[[Primary mediastinal B-cell lymphoma]] | ||
| Line 38: | Line 45: | ||
*[[Sarcomatoid renal cell carcinoma]] | *[[Sarcomatoid renal cell carcinoma]] | ||
*[[Soft tissue sarcoma]] | *[[Soft tissue sarcoma]] | ||
| − | |||
| − | |||
*[[Thymoma]] | *[[Thymoma]] | ||
*[[Transformed lymphoma]] | *[[Transformed lymphoma]] | ||
| − | *[[ | + | *[[Urothelial carcinoma]] |
| − | |||
*[[Waldenström macroglobulinemia]] | *[[Waldenström macroglobulinemia]] | ||
</div> | </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== | ||
| − | *[ | + | *[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== | ||
| − | * | + | * 1974-08-07: Initial FDA approval |
| − | * | + | * 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== | ||
*'''Code name:''' FI-106 | *'''Code name:''' FI-106 | ||
| Line 84: | Line 103: | ||
|Cloridrato DE | |Cloridrato DE | ||
|Doxorrubicina Colhidrol | |Doxorrubicina Colhidrol | ||
| − | |||
|Deldoxin | |Deldoxin | ||
|Dicladox | |Dicladox | ||
|Dobicin | |Dobicin | ||
| + | |Dobixin | ||
|- | |- | ||
| − | |||
|Doxo | |Doxo | ||
|Doxobin | |Doxobin | ||
| Line 97: | Line 115: | ||
|Doxolem | |Doxolem | ||
|Doxonolver | |Doxonolver | ||
| + | |Doxor | ||
|- | |- | ||
| − | |||
|Doxorrubicina | |Doxorrubicina | ||
|Doxoruben | |Doxoruben | ||
| Line 106: | Line 124: | ||
|Doxorubin | |Doxorubin | ||
|Doxotec | |Doxotec | ||
| + | |Doxtie | ||
|- | |- | ||
| − | |||
|Duxocin | |Duxocin | ||
|Evacet | |Evacet | ||
| Line 115: | Line 133: | ||
|Ifadox | |Ifadox | ||
|Kemodoxa | |Kemodoxa | ||
| + | |Lyphidox | ||
|- | |- | ||
| − | |||
| − | |||
|Nagun | |Nagun | ||
|Neoxane | |Neoxane | ||
| Line 124: | Line 141: | ||
|Onkodox | |Onkodox | ||
|Onkostatil | |Onkostatil | ||
| − | |||
|Pallagicin | |Pallagicin | ||
|Ranxas | |Ranxas | ||
| + | |- | ||
|Rastocin | |Rastocin | ||
|Ribodoxo | |Ribodoxo | ||
| Line 137: | 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:Drugs]] | ||
| Line 145: | Line 163: | ||
[[Category:Anthracyclines]] | [[Category:Anthracyclines]] | ||
| − | [[Category:Topoisomerase inhibitors]] | + | [[Category:Topoisomerase II inhibitors]] |
[[Category:Adrenocortical carcinoma medications]] | [[Category:Adrenocortical carcinoma medications]] | ||
| Line 151: | Line 169: | ||
[[Category:Anaplastic large cell lymphoma medications]] | [[Category:Anaplastic large cell lymphoma medications]] | ||
[[Category:B-cell acute lymphoblastic leukemia medications]] | [[Category:B-cell acute lymphoblastic leukemia medications]] | ||
| − | |||
[[Category:Bladder cancer medications]] | [[Category:Bladder cancer medications]] | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
[[Category:Burkitt lymphoma medications]] | [[Category:Burkitt lymphoma medications]] | ||
| − | [[Category: | + | [[Category:Cutaneous basal cell carcinoma medications]] |
| + | [[Category:Cutaneous squamous cell carcinoma medications]] | ||
[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:Endometrial cancer medications]] | ||
[[Category:Ewing sarcoma medications]] | [[Category:Ewing sarcoma medications]] | ||
[[Category:Follicular lymphoma medications]] | [[Category:Follicular lymphoma medications]] | ||
[[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: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:Mediastinal gray-zone lymphoma medications]] | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| + | [[Category:Neuroblastoma medications]] | ||
[[Category:Osteosarcoma medications]] | [[Category:Osteosarcoma medications]] | ||
[[Category:Pancreatic NET medications]] | [[Category:Pancreatic NET medications]] | ||
| Line 176: | Line 199: | ||
[[Category:Sarcomatoid renal cell carcinoma medications]] | [[Category:Sarcomatoid renal cell carcinoma medications]] | ||
[[Category:Soft tissue sarcoma medications]] | [[Category:Soft tissue sarcoma medications]] | ||
| − | |||
| − | |||
[[Category:Thymoma medications]] | [[Category:Thymoma medications]] | ||
[[Category:Transformed lymphoma medications]] | [[Category:Transformed lymphoma medications]] | ||
| + | [[Category:Urothelial carcinoma medications]] | ||
| + | [[Category:Waldenström macroglobulinemia medications]] | ||
| − | [[Category: | + | *[[Category:Acute myeloid leukemia medications (historic)]] |
| − | [[Category: | + | *[[Category:Chronic lymphocytic leukemia medications (historic)]] |
| − | [[Category: | + | *[[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: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)
- Bladder cancer
- Breast cancer
- Hepatocellular carcinoma
- Non-Hodgkin lymphoma
- Osteosarcoma
Diseases for which it is used
- 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
- Classical Hodgkin lymphoma
- Hodgkin lymphoma, nodular lymphocyte-predominant
- Kaposi sarcoma
- Malignant pleural mesothelioma
- Marginal zone lymphoma
- Mediastinal gray-zone lymphoma
- Multiple myeloma
- Neuroblastoma
- Pancreatic NET
- Post-transplant lymphoproliferative disorder
- Primary mediastinal B-cell lymphoma
- Rhabdomyosarcoma
- Sarcomatoid renal cell carcinoma
- Soft tissue sarcoma
- Thymoma
- Transformed lymphoma
- Urothelial carcinoma
- Waldenström macroglobulinemia
Diseases for which it was used
- Acute myeloid leukemia
- Chronic lymphocytic leukemia
- Gastric cancer
- Non-small cell lung cancer
- Ovarian cancer
- Prostate cancer
- Small cell lung cancer
- Testicular cancer
Patient drug information
- Doxorubicin (Adriamycin) patient drug information (Chemocare)[3]
- Doxorubicin (Adriamycin) package insert page 1[1]
- Doxorubicin (Adriamycin) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 1974-08-07: Initial FDA approval
- 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 lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the 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. (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 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
- 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
Categories:
- Drugs
- Intra-arterial medications
- Intravenous medications
- Intravesical medications
- Vesicant
- Anthracyclines
- Topoisomerase II inhibitors
- Adrenocortical carcinoma medications
- Adult T-cell leukemia-lymphoma medications
- Anaplastic large cell lymphoma medications
- B-cell acute lymphoblastic leukemia medications
- Bladder cancer medications
- Breast cancer medications
- Burkitt lymphoma medications
- Cutaneous basal cell carcinoma medications
- Cutaneous squamous cell carcinoma medications
- Diffuse large B-cell lymphoma medications
- Endometrial cancer medications
- Ewing sarcoma medications
- Follicular lymphoma medications
- Hepatoblastoma medications
- Hepatocellular carcinoma medications
- High-grade B-cell lymphoma medications
- HIV-associated lymphoma medications
- Classical Hodgkin lymphoma medications
- Hodgkin lymphoma, nodular lymphocyte-predominant medications
- Kaposi sarcoma medications
- Malignant pleural mesothelioma medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- Mediastinal gray-zone lymphoma medications
- Multiple myeloma medications
- Neuroblastoma medications
- Osteosarcoma medications
- Pancreatic NET medications
- Peripheral T-cell lymphoma medications
- Post-transplant lymphoproliferative disorder medications
- Primary mediastinal B-cell lymphoma medications
- Rhabdomyosarcoma medications
- Sarcomatoid renal cell carcinoma medications
- Soft tissue sarcoma medications
- Thymoma medications
- Transformed lymphoma medications
- Urothelial carcinoma medications
- Waldenström macroglobulinemia medications
- Acute myeloid leukemia medications (historic)
- Chronic lymphocytic leukemia medications (historic)
- Gastric cancer medications (historic)
- Non-small cell lung cancer medications (historic)
- Ovarian cancer medications (historic)
- Prostate cancer medications (historic)
- Small cell lung cancer medications (historic)
- Testicular cancer medications (historic)
- FDA approved in 1974
- EMA approved in 1996
- WHO Essential Cancer Medicine