Difference between revisions of "Cyclophosphamide (Cytoxan)"
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*1959-11-16: initial FDA approval | *1959-11-16: initial FDA approval | ||
*2012-03-31 (oldest label available at Drugs @ FDA): Approved for [[:Category:Lymphomas|malignant lymphomas]] (Stages III and IV of the Ann Arbor staging system), [[Classical Hodgkin lymphoma|Hodgkin’s disease]], lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, [[Diffuse large B-cell lymphoma|histiocytic lymphoma]], [[Burkitt lymphoma]]; [[multiple myeloma]], leukemias: [[Chronic lymphocytic leukemia]], [[Chronic myeloid leukemia|chronic granulocytic leukemia]] (it is usually ineffective in acute blastic crisis), [[Acute myeloid leukemia|acute myelogenous and monocytic leukemia]], [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic (stem-cell) leukemia]] in children (cyclophosphamide given during remission is effective in prolonging its duration); [[Cutaneous T-cell lymphoma|mycosis fungoides]] (advanced disease); [[neuroblastoma]] (disseminated disease); [[Ovarian cancer|adenocarcinoma of ovary]]; [[retinoblastoma]]; [[Breast cancer|carcinoma of the breast]] ''(No supporting studies are cited)'' | *2012-03-31 (oldest label available at Drugs @ FDA): Approved for [[:Category:Lymphomas|malignant lymphomas]] (Stages III and IV of the Ann Arbor staging system), [[Classical Hodgkin lymphoma|Hodgkin’s disease]], lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, [[Diffuse large B-cell lymphoma|histiocytic lymphoma]], [[Burkitt lymphoma]]; [[multiple myeloma]], leukemias: [[Chronic lymphocytic leukemia]], [[Chronic myeloid leukemia|chronic granulocytic leukemia]] (it is usually ineffective in acute blastic crisis), [[Acute myeloid leukemia|acute myelogenous and monocytic leukemia]], [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic (stem-cell) leukemia]] in children (cyclophosphamide given during remission is effective in prolonging its duration); [[Cutaneous T-cell lymphoma|mycosis fungoides]] (advanced disease); [[neuroblastoma]] (disseminated disease); [[Ovarian cancer|adenocarcinoma of ovary]]; [[retinoblastoma]]; [[Breast cancer|carcinoma of the breast]] ''(No supporting studies are cited)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *1958-10-13: EURD | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2013-03-25: New additional indication and a new dosage for the treatment of [[pheochromocytoma]]. | *2013-03-25: New additional indication and a new dosage for the treatment of [[pheochromocytoma]]. | ||
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[[Category:FDA approved in 1959]] | [[Category:FDA approved in 1959]] | ||
| + | [[Category:EMA approved in 1958]] | ||
[[Category:PMDA approved drugs]] | [[Category:PMDA approved drugs]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 12:32, 13 June 2023
General information
Class/mechanism: Alkylating agent; transformed primarily in the liver to active metabolites which alkylate and crosslink DNA.[1][2]
Route: IV, PO
Extravasation: irritant or neutral, depending on reference; n/a
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, Medscape,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established (work in progress)
- Non-Hodgkin lymphoma
Diseases for which it is used
- Acquired coagulopathy
- Acute myeloid leukemia
- Adult T-cell leukemia-lymphoma
- Anaplastic glioma
- Anaplastic large cell lymphoma
- B-cell acute lymphoblastic leukemia
- Bladder cancer
- Breast cancer
- Burkitt lymphoma
- Central nervous system (CNS) cancer
- Chronic lymphocytic leukemia
- Chronic myeloid leukemia
- CNS lymphoma
- Diffuse large B-cell lymphoma
- Ewing sarcoma
- Gestational trophoblastic neoplasia
- Glioblastoma
- HIV-associated lymphoma
- Classical Hodgkin lymphoma
- Hodgkin lymphoma, nodular lymphocyte-predominant
- Large granular lymphocytic leukemia
- Light-chain (AL) amyloidosis
- Marginal zone lymphoma
- Mediastinal gray-zone lymphoma
- Medulloblastoma
- Multiple myeloma
- Neuroblastoma
- Osteosarcoma
- Pheochromocytoma
- Plasma cell leukemia
- Post-transplant lymphoproliferative disorder
- Primary mediastinal B-cell lymphoma
- Prostate cancer
- Rhabdomyosarcoma
- T-cell acute lymphoblastic leukemia
- Thymoma
- Transformed lymphoma
- Waldenström macroglobulinemia
Diseases for which it was used
- Non-small cell lung cancer
- Ovarian cancer
- Renal cell carcinoma
- Small cell lung cancer
- Testicular cancer
Patient drug information
- Cyclophosphamide (Cytoxan) package insert[1]
- Cyclophosphamide (Cytoxan) patient drug information (Chemocare)[3]
- Cyclophosphamide (Cytoxan) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 1959-11-16: initial FDA approval
- 2012-03-31 (oldest label available at Drugs @ FDA): Approved for malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt lymphoma; multiple myeloma, leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia in children (cyclophosphamide given during remission is effective in prolonging its duration); mycosis fungoides (advanced disease); neuroblastoma (disseminated disease); adenocarcinoma of ovary; retinoblastoma; carcinoma of the breast (No supporting studies are cited)
History of changes in EMA indication
- 1958-10-13: EURD
History of changes in PMDA indication
- 2013-03-25: New additional indication and a new dosage for the treatment of pheochromocytoma.
- 2015-06-26: revised indication and a new dosage for the relief of symptoms of malignant lymphoma.
- 2019-03-26: New indication for the treatment prior to tumor-specific T-cell infusion therapy.
- 2021-08-21: New indication and a new dosage for the treatment of systemic AL amyloidosis.
Also known as
- Code names: Asta B 518, B-518, WR-138719
- Generic names: CP monohydrate, CPM, cyclophosphamid monohydrate, cyclophosphamide monohydrate
- Brand names:
| Synonyms | |||||||
|---|---|---|---|---|---|---|---|
| Alkyloxan | Biodoxan | Carloxan | Ciclofosfamida | Ciclokebir | Cicloxal | Clafen | Claphene |
| Cyclam | Cycloblastin | Cycloblastine | CYCLO-cell | Cycloferon | Cyclomide | Cyclophar | Cyclophospham |
| Cyclophosphamid | Cyclophosphane | Cyclostin | Cyclostine | Cyclotox | Cycloxan | Cycram | Cydoxan |
| Cyklofosfamid | Cyphos | Cytophosphan | Cytoxan | Cytoxan Lyophilized | Endoxan | Endoxan-N | Endoxana |
| Enduxan | Formitex | Fosfaseron | Genoxal | Genuxal | Hidrofosmin | Ledoxan | Ledoxina |
| Mitoxan | Neophos | Neosar | Oncomide | Oncophos | Procytox | Revimmune | Sendoxan |
| Siklofos | Syklofosfamid | Tymtran | Zuviphos | Zycram | Zytoxan | ||
References
Categories:
- Drugs
- Intravenous medications
- Oral medications
- Irritant
- Neutral
- Alkylating agents
- Nitrogen mustards
- Immunosuppressants
- Acquired coagulopathy medications
- Acute myeloid leukemia medications
- Adult T-cell leukemia-lymphoma medications
- Anaplastic glioma medications
- Anaplastic large cell lymphoma medications
- B-cell acute lymphoblastic leukemia medications
- Bladder cancer medications
- Breast cancer medications
- Burkitt lymphoma medications
- CNS lymphoma medications
- Chronic lymphocytic leukemia medications
- Chronic myeloid leukemia medications
- Diffuse large B-cell lymphoma medications
- Ewing sarcoma medications
- Follicular lymphoma medications
- Gestational trophoblastic neoplasia medications
- Glioblastoma medications
- HIV-associated lymphoma medications
- Classical Hodgkin lymphoma medications
- Hodgkin lymphoma, nodular lymphocyte-predominant medications
- Large granular lymphocytic leukemia medications
- Light-chain (AL) amyloidosis medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- Mediastinal gray-zone lymphoma medications
- Medulloblastoma medications
- Multiple myeloma medications
- Neuroblastoma medications
- Osteosarcoma medications
- Peripheral T-cell lymphoma medications
- Pheochromocytoma medications
- Plasma cell leukemia medications
- Post-transplant lymphoproliferative disorder medications
- Primary mediastinal B-cell lymphoma medications
- Prostate cancer medications
- Rhabdomyosarcoma medications
- T-cell acute lymphoblastic leukemia medications
- Thymoma medications
- Transformed lymphoma medications
- Waldenström macroglobulinemia medications
- Non-small cell lung cancer medications (historic)
- Ovarian cancer medications (historic)
- Renal cell carcinoma medications (historic)
- Small cell lung cancer medications (historic)
- Testicular cancer medications (historic)
- FDA approved in 1959
- EMA approved in 1958
- PMDA approved drugs
- WHO Essential Cancer Medicine