Difference between revisions of "Elotuzumab (Empliciti)"

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m (Jwarner moved page Elotuzumab (HuLuc63) to Elotuzumab (Empliciti): FDA approval)
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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 package insert.
 
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 package insert.
  
==Preliminary data==
+
==Diseases for which it is used==
===[[Multiple myeloma]]===
+
*[[Multiple myeloma]]
# Lonial S, Vij R, Harousseau JL, Facon T, Moreau P, Mazumder A, Kaufman JL, Leleu X, Tsao LC, Westland C, Singhal AK, Jagannath S. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J Clin Oncol. 2012 Jun 1;30(16):1953-9. Epub 2012 Apr 30. [http://www.ncbi.nlm.nih.gov/pubmed/22547589 PubMed]
 
# '''Abstract:''' Richardson, Paul G., Jagannath, Sundar, Moreau, Philippe, Jakubowiak, Andrzej, Raab, Marc S, Facon, Thierry, Vij, Ravi, White, Darrell J., Reece, Donna, Benboubker, Lotfi, Zonder, Jeffrey A., Deng, Wei, Kroog, Glenn, Singhal, Anil K, Lonial, Sagar. A Phase 2 Study of Elotuzumab (Elo) in Combination with Lenalidomide and Low-Dose Dexamethasone (Ld) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results. ASH Annual Meeting Abstracts 2012 120: 202
 
# Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. Epub 2015 Jun 2. [http://www.nejm.org/doi/full/10.1056/NEJMoa1505654 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/26035255 PubMed]
 
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==Dexamethasone, Elotuzumab & Lenalidomide {{#subobject:b79daa |Regimen=1}}==
 
  
===Regimen, Richardson et al. 2012 {{#subobject:f2d044 |Variant=1}}===
 
<span
 
style="background:#EEEE00;
 
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border-style:solid;">Phase II</span>
 
 
''Note: the dose of elotuzumab reported here is that used in the ongoing phase III trials.''
 
 
*[[Dexamethasone (Decadron)]] 40 mg PO once per week or 28 mg PO plus 8 mg IV on [[Elotuzumab (HuLuc63)]] dosing days
 
*[[Elotuzumab (HuLuc63)]] 20 mg/kg IV once on days 1, 8, 15, 22 of cycles 1 & 2, then once on days 1 & 15 of subsequent cycles
 
*[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21
 
 
'''28-day cycles'''
 
 
===References===
 
# '''Abstract:''' Richardson, Paul G., Jagannath, Sundar, Moreau, Philippe, Jakubowiak, Andrzej, Raab, Marc S, Facon, Thierry, Vij, Ravi, White, Darrell J., Reece, Donna, Benboubker, Lotfi, Zonder, Jeffrey A., Deng, Wei, Kroog, Glenn, Singhal, Anil K, Lonial, Sagar. A Phase 2 Study of Elotuzumab (Elo) in Combination with Lenalidomide and Low-Dose Dexamethasone (Ld) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results. ASH Annual Meeting Abstracts 2012 120: 202
 
-->
 
 
==Patient drug information==
 
==Patient drug information==
 
No information available.
 
No information available.
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
 
* 5/19/2014: Granted FDA [http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm Breakthrough Therapy designation] "for use in combination with [[Lenalidomide (Revlimid) | lenalidomide]] and [[Dexamethasone (Decadron) | dexamethasone]] for the treatment of [[Multiple myeloma | multiple myeloma]] in patients who have received one or more prior therapies."
 
* 5/19/2014: Granted FDA [http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm Breakthrough Therapy designation] "for use in combination with [[Lenalidomide (Revlimid) | lenalidomide]] and [[Dexamethasone (Decadron) | dexamethasone]] for the treatment of [[Multiple myeloma | multiple myeloma]] in patients who have received one or more prior therapies."
 +
* 11/30/2015: FDA approved "in combination with [[Lenalidomide (Revlimid) | lenalidomide]] and [[Dexamethasone (Decadron) | dexamethasone] for the treatment of patients with [[Multiple myeloma | multiple myeloma]] who have received one to three prior therapies."
  
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==Also known as==
 +
HuLuc63
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
  
[[Category:Investigational]]
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[[Category:Drugs FDA approved in 2015]]

Revision as of 02:01, 1 December 2015

0 regimens on this page
0 variants on this page

General information

Class/mechanism from NCI Drug Dictionary: A humanized monoclonal antibody directed against the human CS1 (CD2 subset 1, CRACC, SLAMF7) antigen with potential antineoplastic activity. Elotuzumab binds to the CS1 antigen, which may trigger antibody-dependent cellular cytotoxicity (ADCC) in cells expressing CS1.[1]
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 package insert.

Diseases for which it is used

Patient drug information

No information available.

History of changes in FDA indication

Also known as

HuLuc63

References