Overview
11 DESCRIPTION Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7) protein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer (NK) cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage. Elotuzumab directly activates NK cells through the SLAMF7 pathway. Elotuzumab also targets SLAMF7 on myeloma cells and interacts with Fc receptors on effector cells to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Indications
- 1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Common Doses
- 10 mg
- 20 mg
- 28 mg
- 8 mg
Dosage
2 DOSAGE AND ADMINISTRATION • With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. (2.1) • With pomalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity. (2.2) • Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen. (2.3) 2.
Contraindications
- 4 CONTRAINDICATIONS None. None (4)
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other sections of the label: • Infusion reaction [see Warnings and Precautions (5.1) ] . • Infections [see Warnings and Precautions (5.2) ] . • Second Primary Malignancies [ see Warnings and Precautions (5.3) ] . • Hepatotoxicity [see Warnings and Precautions (5.4) ] . • Interference with determination of complete response [see Warnings and Precautions (5.5) ] .
Interactions
- 7 DRUG INTERACTIONS 7.1 Drug Interactions For important drug interactions involving lenalidomide, pomalidomide and dexamethasone, refer to their respective prescribing information. 7.2 Laboratory Test Interference EMPLICITI may be detected in the SPEP and serum immunofixation assays of myeloma patients and could interfere with correct response classification. A small peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation may potentially be attributed to EMPLICITI, particularly in patients whose endogenous myeloma protein is IgA, IgM, IgD, or lambda light chain restricted.