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Therapeutic Elotuzumab antibody from the original Empliciti® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
SLAMF7 |
Monoclonal Antibody |
Empliciti® |
25 mg/mL |
– |
6 mg |
-80 °C |
09/2022 |
243,00 € |
||
SLAMF7 |
Monoclonal Antibody |
Empliciti® |
25 mg/mL |
– |
6 mg |
-80°C |
02/2024 |
243,00 € |
| Drug name | Empliciti® |
| INN | Elotuzumab |
| API type | Elotuzumab is produced in NS0 cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies. |
| ATC code | L01XC23 |
| Target of antibody | SLAMF7 |
| General function | Elotuzumab 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 Ireland |
| Marketing authorisation numbers | EU/1/16/1088/001 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| 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 release | CATALENT ANAGNI S.R.L. Loc. Fontana del Ceraso snc Strada Provinciale Casilina, 41 03012 ANAGNI (FR) Italy and Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15, D15 H6EF Ireland |
| Max shelf life | 36 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sucrose Sodium citrate Citric acid monohydrate Polysorbate 80 (E433) |
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