Therapeutic Elotuzumab antibody from the original Empliciti® commercial drug

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Molecular Class
Drug Brand
Product Concentration
Quantity per vial
Storage Temperature
Expiry Date
Monoclonal Antibody
25 mg/mL
6 mg
2-8°C / -80°C
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Empliciti® / Elotuzumab Reference Product

Drug nameEmpliciti®
API typeElotuzumab is produced in NS0 cells by recombinant DNA technology.
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies.
ATC code
Target of antibody
General functionElotuzumab is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
In combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the signaling lymphocyte activation molecule family member 7 (SLAMF7) protein. SLAMF7 is highly expressed on multiple myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on natural killer cells (NK), normal plasma cells, and other immune cells including some T cell subsets, monocytes, B cells, macrophages, and pDCs (plasmacytoid dendritic cells), but is not detected on normal solid tissues or haematopoietic stem cells.
Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors enhancing anti-myeloma activity in vitro. Elotuzumab also targets SLAMF7 on myeloma cells and through interactions with Fc receptors on specific immune cells, promotes the killing of myeloma cells through NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and
macrophage-mediated antibody-dependant cellular phagocytosis (ADCP). In nonclinical models,
elotuzumab has demonstrated synergistic activity when combined with lenalidomide, pomalidomide or bortezomib.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)
Original license holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Marketing authorisation numbers
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Name of the manufacturer of the biological active substance
Bristol-Myers Squibb Company
6000 Thompson Road, East Syracuse
New York 13057
United States
Name and address of the manufacturer(s) responsible for batch releaseCATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale Casilina, 41
03012 ANAGNI (FR)
Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
Sodium citrate
Citric acid monohydrate
Polysorbate 80 (E433)
Evidentic Support
+49 (0) 30 959 99 8831

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