Difference between revisions of "Ofatumumab (Arzerra)"
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[Chronic lymphocytic leukemia | + | *[[Chronic lymphocytic leukemia]] |
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
*[[Follicular lymphoma]] | *[[Follicular lymphoma]] | ||
| Line 22: | Line 22: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*10/26/2009: Granted FDA accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to [[Fludarabine (Fludara)]] and [[Alemtuzumab (Campath)]] | *10/26/2009: Granted FDA accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to [[Fludarabine (Fludara)]] and [[Alemtuzumab (Campath)]] | ||
| − | *4/17/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm393823.htm FDA approved] in combination with [[Chlorambucil (Leukeran)]], for the treatment of previously untreated patients with [[Chronic lymphocytic leukemia | + | *4/17/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm393823.htm FDA approved] in combination with [[Chlorambucil (Leukeran)]], for the treatment of previously untreated patients with [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL)]], for whom [[Fludarabine (Fludara)|fludarabine]]-based therapy is considered inappropriate. |
| − | *1/19/2016: Approval expanded "for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive [[Chronic lymphocytic leukemia | + | *1/19/2016: Approval expanded "for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL)]]." |
==Also known as== | ==Also known as== | ||
Revision as of 18:29, 31 July 2019
General information
Class/mechanism: Anti-CD20 monoclonal antibody that binds to small and large extracellular loops of the CD20
molecule which is expressed on B-cells. The Fc domain of ofatumumab has been observed in vitro to mediate
immune effector functions and B-cell lysis, which is hypothesized to involve complement-dependent cytotoxicity (CDC) and/or antibody-dependent cell mediated cytotoxicity (ADCC).[1][2][3]
Route: IV
Extravasation: no information
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 used
- Chronic lymphocytic leukemia
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Hodgkin lymphoma
- Waldenström macroglobulinemia
Patient drug information
- Ofatumumab (Arzerra) patient drug information (Chemocare)[4]
- Patient counseling information can be found in the Ofatumumab (Arzerra) package insert[1]
- Ofatumumab (Arzerra) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 10/26/2009: Granted FDA accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to Fludarabine (Fludara) and Alemtuzumab (Campath)
- 4/17/2014: FDA approved in combination with Chlorambucil (Leukeran), for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.
- 1/19/2016: Approval expanded "for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL)."
Also known as
- Code name: HuMax-CD20
- Brand name: Arzerra