Difference between revisions of "Nelarabine (Arranon)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Purine analog, antimetabolite. Nelarabine is metabolized to the cytotoxic deoxyguanosine | + | Class/mechanism: Purine analog, antimetabolite. Nelarabine is metabolized to the cytotoxic deoxyguanosine analog, 9-β-Darabinofuranosylguanine (ara-G), which is eventually converted to ara-GTP. ara-GTP is incorporated into DNA and leads to inhibition of DNA synthesis and cell death.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf Nelarabine (Arranon) package insert]</ref><ref>[[:File:Nelarabine.pdf|Nelarabine (Arranon) package insert (locally hosted backup)]]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: [[neutral]] | <br>Extravasation: [[neutral]] | ||
| − | 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 | + | 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, or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 10 | + | * 2005-10-28: Accelerated approval for the treatment of patients with [[T-cell acute lymphoblastic leukemia | T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]] whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ''(Based on Berg et al. 2005 and CALGB 19801)'' |
| − | ** | + | **2019-07-31: Converted to regular approval for the treatment of patients with [[T-cell acute lymphoblastic leukemia |T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]] in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ''(Based on COG AALL0434)'' |
| − | + | ==History of changes in EMA indication== | |
| + | *2007-08-22: Initial authorization as Atriance | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2007-09-22: Initial notice of compliance with conditions for use in the treatment of patients with [[T-cell acute lymphoblastic leukemia |T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]] whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. | ||
| + | *2020-01-22: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2007-10-19: Initial approval for the treatment of relapsed or refractory [[T-cell acute lymphoblastic leukemia |T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' 506U78 | *'''Code name:''' 506U78 | ||
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[[Category:Antimetabolites]] | [[Category:Antimetabolites]] | ||
| − | [[Category:Purine | + | [[Category:Purine analogs]] |
[[Category:T-cell acute lymphoblastic leukemia medications]] | [[Category:T-cell acute lymphoblastic leukemia medications]] | ||
[[Category:FDA approved in 2005]] | [[Category:FDA approved in 2005]] | ||
| + | [[Category:EMA approved in 2007]] | ||
| + | [[Category:Health Canada approved in 2007]] | ||
| + | [[Category:PMDA approved in 2007]] | ||
Latest revision as of 00:14, 6 July 2024
General information
Class/mechanism: Purine analog, antimetabolite. Nelarabine is metabolized to the cytotoxic deoxyguanosine analog, 9-β-Darabinofuranosylguanine (ara-G), which is eventually converted to ara-GTP. ara-GTP is incorporated into DNA and leads to inhibition of DNA synthesis and cell death.[1][2]
Route: IV
Extravasation: neutral
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, or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Nelarabine (Arranon) package insert PDF pages 17-19[1]
- Nelarabine (Arranon) patient drug information (Chemocare)[3]
- Nelarabine (Arranon) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2005-10-28: Accelerated approval for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (Based on Berg et al. 2005 and CALGB 19801)
- 2019-07-31: Converted to regular approval for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (Based on COG AALL0434)
History of changes in EMA indication
- 2007-08-22: Initial authorization as Atriance
History of changes in Health Canada indication
- 2007-09-22: Initial notice of compliance with conditions for use in the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
- 2020-01-22: Conditions were met
History of changes in PMDA indication
- 2007-10-19: Initial approval for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Also known as
- Code name: 506U78
- Brand names: Arranon, Atriance