Difference between revisions of "Ofatumumab (Arzerra)"
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==General information== | ==General information== | ||
Class/mechanism: Anti-CD20 monoclonal antibody that binds to small and large extracellular loops of the CD20 | 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 | 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).<ref name="insert">[http://us.gsk.com/products/assets/us_arzerra.pdf Ofatumumab (Arzerra) package insert]</ref><ref>[ | + | immune effector functions and B-cell lysis, which is hypothesized to involve complement-dependent cytotoxicity (CDC) and/or antibody-dependent cell mediated cytotoxicity (ADCC).<ref name="insert">[http://us.gsk.com/products/assets/us_arzerra.pdf Ofatumumab (Arzerra) package insert]</ref><ref>[[Media:Ofatumumab.pdf | Ofatumumab (Arzerra) package insert (locally hosted backup)]]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
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==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: | + | *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 (CLL) and Small lymphocytic lymphoma (SLL)|chronic lymphocytic leukemia (CLL)]], for whom [[Fludarabine (Fludara)|fludarabine]]-based therapy is considered inappropriate. |
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| + | ==Also known as== | ||
| + | HuMax-CD20. | ||
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 04:58, 18 April 2014
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]
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
- Aggressive Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)
- Follicular lymphoma
Patient drug information
- Ofatumumab (Arzerra) patient drug information (Chemocare)[3]
- Ofatumumab (Arzerra) patient drug information (UpToDate)[4]
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.
Also known as
HuMax-CD20.