Elotuzumab

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.

• • 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.ICD-10: C90.00

• None.contraindicated

• 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) 2.1 Recommended Dosing when EMPLICITI Is Used in Combination with Lenalidomide and Dexamethasone The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle) and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone as described below. Continue treatment until disease progression or unacceptable toxicity. Refer to the dexamethasone and lenalidomide prescribing information for additional information. Administer premedications before each dose of EMPLICITI [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] . Administer dexamethasone as follows: • On days that EMPLICITI is administered, give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI. • On days that EMPLICITI is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally. The recommended dosing is presented in Table 1.

• 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. (5.2) • Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI. (5.3) • Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected. (5.4) • Interference with determination of complete response: EMPLICITI can interfere with assays used to monitor M-protein. This interference can impact the determination of complete response. (5.5) 5.1 Infusion Reactions EMPLICITI can cause infusion reactions. Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial and 3.3% in the ELOQUENT-3 trial. In the ELOQUENT-2 trial, all reports of infusion reaction were Grade 3 or lower. In the ELOQUENT-2 trial, Grade 3 infusion reactions occurred in 1% of patients. The most common symptoms of an infusion reaction included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the ELOQUENT-2 trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose.

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) ] . Most common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia. (6.1) • with pomalidomide and dexamethasone are constipation and hyperglycemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. EMPLICITI in Combination with Lenalidomide and Dexamethasone [ELOQUENT-2] The safety data described in this section are based on the ELOQUENT-2 study, a randomized, open-label clinical trial in patients with previously treated multiple myeloma. In ELOQUENT-2, EMPLICITI 10 mg/kg was administered with lenalidomide and dexamethasone [see Clinical Studies (14) ] .

Pregnancy: Embryo-fetal toxicity in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. (8.1) 8.1 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. Lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. Refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. Lenalidomide and pomalidomide are only available through a REMS program. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of EMPLICITI in human milk, the effects on the breastfed child, or the effects on milk production.

Metabolism

Elotuzumab exhibits nonlinear pharmacokinetics (PK) resulting in greater than proportional increases in area under the concentration-time curve (AUC) indicative of target-mediated clearance. The administration of the recommended 10 mg/kg EMPLICITI regimen with lenalidomide and dexamethasone is predicted to result in geometric mean (CV%) steady-state trough concentrations of 194 μg/mL (52%).

The dose of EMPLICITI at which severe toxicity occurs is not known. EMPLICITI does not appear to be removed by dialysis as determined in a study of patients with renal impairment. In case of overdosage, monitor patients closely for signs or symptoms of adverse reactions and institute appropriate symptomatic treatment.

• Nov 30, 2015BLABLA761035Bristol Myers Squibb

1. 1Plasma Cell Myeloma55911%
2. 2Pneumonia3046.0%
3. 3Death2985.8%
4. 4Malignant Neoplasm Progression2454.8%
5. 5Fatigue2344.6%
6. 6Diarrhoea2294.5%
7. 7Pyrexia2214.3%
8. 8Drug Ineffective1983.9%
9. 9Neutropenia1923.8%
10. 10Anaemia1723.4%
11. 11Thrombocytopenia1442.8%
12. 12Platelet Count Decreased1342.6%
13. 13Off Label Use1292.5%
14. 14Sepsis1152.3%
15. 15Neuropathy Peripheral1122.2%

The 10 most recently updated of 74 ClinicalTrials.gov registrations naming Elotuzumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
  Recruiting · Phase 3 · Interventional · 380 enrolled · AbbVie
  NCT06158841updated 2026-06-12
• Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosis
  Active not recruiting · Phase 2 · Interventional · 15 enrolled · M.D. Anderson Cancer Center
  NCT04517851updated 2026-06-11
• MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
  Recruiting · Phase 3 · Interventional · 492 enrolled · Pfizer
  NCT06152575updated 2026-06-05
• A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
  Recruiting · Phase 3 · Interventional · 795 enrolled · Janssen Research & Development, LLC
  NCT06208150updated 2026-06-05
• Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
  Recruiting · Phase 3 · Interventional · 380 enrolled · Hoffmann-La Roche
  NCT07555938updated 2026-05-27
• Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies
  Active not recruiting · Phase 1 · Interventional · 12 enrolled · Abdullah Khan
  NCT05981209updated 2026-05-13
• Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · Yale University
  NCT05002816updated 2026-05-13
• Selinexor and Backbone Treatments of Multiple Myeloma Patients
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 300 enrolled · Karyopharm Therapeutics Inc
  NCT02343042updated 2026-05-04
• S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
  Completed · Phase 1 · Phase 2 · Interventional · 142 enrolled · SWOG Cancer Research Network
  NCT01668719updated 2026-04-28
• Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
  Active not recruiting · Phase 2 · Interventional · 113 enrolled · M.D. Anderson Cancer Center
  NCT02420860updated 2026-04-15

Frequently asked questions

How does Elotuzumab work?

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.

What is Elotuzumab used for?

According to FDA labeling, Elotuzumab carries indications including: • 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Elotuzumab?

Elotuzumab is classified as Other monoclonal antibodies and antibody drug conjugates, SLAMF7-directed Immunostimulatory Antibody, SLAMF7-directed Antibody Interactions, Increased Immunologic Activity, Increased Lymphocyte Activation.

What are the brand names for Elotuzumab?

Elotuzumab is marketed under brand names including Empliciti.

What are the contraindications for Elotuzumab?

Elotuzumab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.