Difference between revisions of "Daratumumab (Darzalex)"
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==Patient drug information== | ==Patient drug information== | ||
*[http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036s000lbl.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref> | *[http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036s000lbl.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref> | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
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==Also known as== | ==Also known as== | ||
| − | HuMax-CD38, JNJ-54767414 | + | HuMax-CD38, JNJ-54767414, DARA |
==References== | ==References== | ||
Revision as of 23:03, 16 November 2015
General information
Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. Daratumumab binds to CD38 and causes apoptosis in CD38-expressing cells via Fc mediated cross-linking, complement-dependent cytotoxicity (CDC), antibody-dependent cell mediated cytotoxicity (ADCC), and antibody dependent cellular phagocytosis (ADCP). CD38 is present on the cell surface of multiple myeloma (MM), plasma leukemia, and natural killer (NK) cells.[1][2][3][4]
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
Patient drug information
History of changes in FDA indication
- 11/16/2015: FDA approved "for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent."[1]
Also known as
HuMax-CD38, JNJ-54767414, DARA