Elotuzumab

What it is and how it works

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.

Mechanism class: SLAMF7-directed Antibody Interactions

Indications

• 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. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • 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.

Dosage and administration (summary)

• 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. • 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. • Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen.

Contraindications

None. None

Warnings and precautions

• Infusion reactions: Premedication is required. Interrupt EMPLICITI for Grade 2 or higher and permanently discontinue for severe infusion reaction. ( 2.3 , 2.4 , 5.1) • Infections: Monitor for fever and other signs of infection and treat promptly. • Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI. • Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected.

Pregnancy

Pregnancy Risk Summary There are no available data on EMPLICITI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with elotuzumab. EMPLICITI is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone.

Storage and supply

(elotuzumab) is white to off-white lyophilized powder available as follows: Carton Content NDC One 300 mg single-dose vial 0003-2291-11 One 400 mg single-dose vial 0003-4522-11 Store EMPLICITI under refrigeration at 2°C to 8°C (36°F-46°F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze or shake.

Source: Elotuzumab (Empliciti) — US FDA prescribing information, 2022-03-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.