Difference between revisions of "Busulfan (Myleran)"
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==Patient drug information== | ==Patient drug information== | ||
*[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bf456fc7-3a79-47f7-8acc-600b5e2f0dc2 Busulfan (Myleran) package insert]<ref name="insert"></ref> | *[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bf456fc7-3a79-47f7-8acc-600b5e2f0dc2 Busulfan (Myleran) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/busulfan.aspx Busulfan (Myleran) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/busulfan.aspx Busulfan (Myleran) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/busulfan-patient-drug-information Busulfan (Myleran) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/busulfan-patient-drug-information Busulfan (Myleran) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/busulfan-patient-drug-information Busulfan (Myleran) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/busulfan-patient-drug-information Busulfan (Myleran) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 1954-06-26: Initial FDA approval |
| − | * | + | *2003-01-23 (oldest label available at Drugs @ FDA): indicated for the palliative treatment of [[Chronic myeloid leukemia|chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia]]. ''(No supporting studies are cited)'' |
| − | + | ==History of changes in EMA indication== | |
| + | *2003-07-09: EURD | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2020-03-25: New indication and a new dosage for the conditioning treatment of malignant lymphoma in patients prior to autologous hematopoietic stem-cell transplantation. | ||
==Also known as== | ==Also known as== | ||
*'''Brand names:''' Busilvex, Busulfex, Myleran | *'''Brand names:''' Busilvex, Busulfex, Myleran | ||
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[[Category:Oral medications]] | [[Category:Oral medications]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | [[Category: | + | [[Category:Alkyl sulfonates]] |
[[Category:Irritant]] | [[Category:Irritant]] | ||
| Line 64: | Line 67: | ||
[[Category:FDA approved in 1954]] | [[Category:FDA approved in 1954]] | ||
| + | [[Category:EMA approved in 2003]] | ||
Latest revision as of 16:41, 13 September 2023
General information
Class/mechanism: Bifunctional alkylating agent which produces guanine-adenine intrastrand crosslinks, inducing apoptosis.[1][2][3][4]
Route: IV, PO
Extravasation: irritant
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 used
- Acute myeloid leukemia
- Acute promyelocytic leukemia
- Chronic lymphocytic leukemia
- Chronic myeloid leukemia
- Ewing sarcoma
- Non-Hodgkin lymphoma
- Myelodysplastic syndrome
- Neuroblastoma
Diseases for which it was used
Patient drug information
- Busulfan (Myleran) package insert[1]
- Busulfan (Myleran) patient drug information (Chemocare)[5]
- Busulfan (Myleran) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 1954-06-26: Initial FDA approval
- 2003-01-23 (oldest label available at Drugs @ FDA): indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. (No supporting studies are cited)
History of changes in EMA indication
- 2003-07-09: EURD
History of changes in PMDA indication
- 2020-03-25: New indication and a new dosage for the conditioning treatment of malignant lymphoma in patients prior to autologous hematopoietic stem-cell transplantation.
Also known as
- Brand names: Busilvex, Busulfex, Myleran
References
- ↑ 1.0 1.1 1.2 Busulfan (Myleran) package insert
- ↑ Busulfan (Myleran) package insert (locally hosted backup)
- ↑ Busulfan (Busulfex) package insert
- ↑ Busulfan (Busulfex) package insert (locally hosted backup)
- ↑ Busulfan (Myleran) patient drug information (Chemocare)
- ↑ Busulfan (Myleran) patient drug information (UpToDate)
Categories:
- Drugs
- Oral medications
- Intravenous medications
- Alkyl sulfonates
- Irritant
- Acute myeloid leukemia medications
- Acute promyelocytic leukemia medications
- Anaplastic large cell lymphoma medications
- Chronic lymphocytic leukemia medications
- Chronic myeloid leukemia medications
- CNS lymphoma medications
- Diffuse large B-cell lymphoma medications
- Ewing sarcoma medications
- Mantle cell lymphoma medications
- Myelodysplastic syndrome medications
- Neuroblastoma medications
- NK- and T-cell lymphoma medications
- Peripheral T-cell lymphoma medications
- Primary mediastinal B-cell lymphoma medications
- Multiple myeloma medications (historic)
- FDA approved in 1954
- EMA approved in 2003