Difference between revisions of "Daratumumab (Darzalex)"
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==General information== | ==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.<ref name=insert>[ | + | 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.<ref name=insert>[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]</ref><ref>[[Media:Daratumumab.pdf|Daratumumab (Darzalex) package insert (locally hosted backup)]]</ref><ref>[http://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=583564 Daratumumab page at NCI Drug Dictionary]</ref><ref>[http://www.darzalex.com/ Darzalex manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf Daratumumab (Darzalex) package insert]<ref name="insert"></ref> |
*[http://www.chemocare.com/chemotherapy/drug-info/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]</ref> | *[http://www.chemocare.com/chemotherapy/drug-info/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/daratumumab.aspx Daratumumab (Darzalex) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/daratumumab-patient-drug-information Daratumumab (Darzalex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/daratumumab-patient-drug-information Daratumumab (Darzalex) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/daratumumab-patient-drug-information Daratumumab (Darzalex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/daratumumab-patient-drug-information Daratumumab (Darzalex) patient drug information (UpToDate)]</ref> | ||
Revision as of 15:30, 11 September 2019
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
- Daratumumab (Darzalex) package insert[1]
- Daratumumab (Darzalex) patient drug information (Chemocare)[5]
- Daratumumab (Darzalex) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 11/16/2015: Granted accelerated approval 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]
- 11/21/2016: Approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. (Label extended to second-line setting)
- 6/27/2019: Approved in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. (Label extended to first-line setting)
Also known as
- Code name: JNJ-54767414
- Brand names: Darzalex, HuMax-CD38
References
- ↑ 1.0 1.1 1.2 1.3 Daratumumab (Darzalex) package insert
- ↑ Daratumumab (Darzalex) package insert (locally hosted backup)
- ↑ Daratumumab page at NCI Drug Dictionary
- ↑ Darzalex manufacturer's website
- ↑ Daratumumab (Darzalex) patient drug information (Chemocare)
- ↑ Daratumumab (Darzalex) patient drug information (UpToDate)