Difference between revisions of "Doxorubicin (Adriamycin)"

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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)''
 
* 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 meta-analysis)''
 
* 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 meta-analysis)''
 +
==History of changes in EMA indication==
 +
*1996-06-21: EURD
 
==History of changes in PMDA indication==
 
==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]].
 
*2014-12-18: Revised indication and a new dosage for the relief of symptoms of [[:Category:Lymphomas|malignant lymphoma]].
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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 13:17, 13 June 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. ↑ 1.0 1.1 1.2 Doxorubicin (Adriamycin) package insert
  2. ↑ Doxorubicin (Adriamycin) package insert (locally hosted backup)
  3. ↑ Doxorubicin (Adriamycin) patient drug information (Chemocare)
  4. ↑ Doxorubicin (Adriamycin) patient drug information (UpToDate)
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