Difference between revisions of "Daratumumab and hyaluronidase (Darzalex Faspro)"
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(Created page with "==General information== Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. Daratumumab binds to CD38 and causes apoptosis in CD38-expressing cells via Fc media...") |
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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. | + | 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+Faspro-pi.pdf Daratumumab and hyaluronidase (Darzalex Faspro) package insert]</ref><ref>[[Media:Daratumumab_hyaluronidase-fihj.pdf | Daratumumab and hyaluronidase (Darzalex Faspro) package insert (locally hosted backup)]]</ref><ref>[https://www.darzalex.com/ Darzalex Faspro manufacturer's website]</ref> |
<br>Route: SC | <br>Route: SC | ||
| − | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf Daratumumab and hyaluronidase (Darzalex Faspro) package insert]<ref name="insert"></ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *5/1/2020: | + | *5/1/2020: [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma FDA approved] for adult patients with newly diagnosed or relapsed/refractory [[multiple myeloma]], as follows: |
**in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, | **in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, | ||
**in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, | **in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, | ||
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*'''Generic name:''' daratumumab and hyaluronidase-fihj | *'''Generic name:''' daratumumab and hyaluronidase-fihj | ||
*'''Brand name:''' Darzalex Faspro | *'''Brand name:''' Darzalex Faspro | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
Revision as of 20:00, 6 May 2020
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]
Route: SC
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
- 5/1/2020: FDA approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma, as follows:
- in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant,
- in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy,
- in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy,
- as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Also known as
- Generic name: daratumumab and hyaluronidase-fihj
- Brand name: Darzalex Faspro