every body [10:<30 mL/minute) or end-stage renal disease requiring dialysis. 1 6 13 Common Adverse Effects Fatigue, 1 2 diarrhea, 1 2 pyrexia, 1 2 constipation, 1 2 cough, 1 2 peripheral neuropathy, 1 nasopharyngitis, 1 2 upper respiratory tract infection, 1 loss of appetite, 1 pneumonia, 1 extremity pain, 1 headache, 1 vomiting, 1 weight loss, 1 lymphopenia, 1 cataracts, 1 oropharyngeal pain, 1 lymphopenia, 1 leukopenia, 1 thrombocytopenia, 1 2 hypoalbuminemia, 1 elevated alkaline phosphatase concentrations, 1 hyperglycemia, 1 hypocalcemia, 1 decreased serum bicarbonate concentrations, 1 hyperkalemia. 1 Interactions for Empliciti No formal drug interaction studies to date. 1 Empliciti Pharmacokinetics Absorption Bioavailability AUC is more than dose proportional over the dose range of 0.5 20 mg/kg. 1 6 10 Following administration of elotuzumab 10 mg/kg IV once weekly for two 28-day cycles followed by 10 mg/kg IV every 2 weeks thereafter, plasma concentrations increase for approximately 8 weeks after initiation of elotuzumab and steady-state concentrations are reached by 2 4 weeks following initiation of administration every 2 weeks. 6 Special Populations Mild hepatic impairment: Systemic exposure similar to that in patients with normal hepatic function. 1 6 Moderate to severe hepatic impairment: Pharmacokinetics not studied. 1 Severe renal impairment (Cl cr> <30 mL/minute) or end-stage renal disease requiring dialysis: Systemic exposure similar to that in patients with normal renal function. 1 6 13 Distribution Extent Not known whether distributed into human milk. 1 Elimination Within about 3 months (geometric mean: 82.4 days) following discontinuance of combination therapy with elotuzumab, lenalidomide, and dexamethasone, elotuzumab concentrations are predicted to decline by approximately 97% from peak steady-state values. 1 17 Special Populations Age (over range of 25 88 years), gender, race, baseline LDH concentrations, and albumin concentrations do not substantially affect pharmacokinetics. 1 6 17 Stability Storage Parenteral Powder for Injection Unreconstituted drug: 2 8 C in original carton to protect from light; do not freeze. 1 Diluted infusion solution: 2 8 C for up to 24 hours (including infusion time) and protected from light; 8 hours of the total 24 hours may be at 20 25 C under room light. 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility Compatible Dextrose 5% in water Sodium chloride 0.9% Actions An IgG 1 kappa immunoglobulin that binds specifically to signaling lymphocytic activation molecule (SLAM) family member 7 (SLAMF7) (expressed on the surface of normal and malignant plasma cells and natural killer [NK] cells) and directly activates NK cells via the SLAMF7 pathway, 1 9 11 16 triggering a host immune response causing lysis of myeloma cells. 1 11 12 16 Mechanism of cell lysis is thought to involve antibody-dependent cell-mediated cytotoxicity (ADCC). 1 11 12 16 Concomitant use of elotuzumab and lenalidomide enhances activation of NK cells compared with either drug alone. 1 12 Increased antitumor activity with elotuzumab in combination with lenalidomide demonstrated in vitro and in vivo. 1 12 Advice to Patients Risk of infusion-related reactions; importance of reporting signs and symptoms of such reactions (e.g., fever, chills, rash, breathing difficulty) that occur during or 24 hours after an infusion of the drug. 1 Importance of taking premedications as directed to minimize risk of infusion-related reactions. 1 Risk of fetal harm when used in combination with lenalidomide. 1 Importance of advising women of childbearing potential and men who are partners of such women to take precautions to avoid fetal exposure to lenalidomide. 1 Importance of women informing a clinician immediately if they are or plan to become pregnant. 1 Importance of advising women to avoid breast-feeding while receiving elotuzumab. 1 Importance of women informing a clinician if they plan to breast-feed. 1 Risk of infection. 1 Importance of reporting signs or symptoms of infection (e.g., cough, fever, flu-like symptoms, shortness of breath, painful rash, burning on urination). 1 Risk of developing a second primary malignancy. 1 Risk of hepatotoxicity and importance of periodic liver function test monitoring. 1 Importance of reporting any manifestations of hepatotoxicity (e.g., jaundice, weakness, loss of appetite, fatigue, confusion, abdominal swelling, unusually colored stool). 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Distribution of elotuzumab is restricted. 4 (See Restricted Distribution Program under Dosage and Administration.) Elotuzumab Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV infusion 300 mg Empliciti Bristol-Myers Squibb 400 mg Empliciti Bristol-Myers Squibb AHFS DI Essentials. Copyright 2017, Selected Revisions May 15, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Bristol-Myers Squibb. Empliciti (elotuzumab) for injection prescribing information. Princeton, NJ; 2015 Nov. 2. Lonial S, Dimopoulos M, Palumbo A et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med . 2015; 373:621-31. [PubMed 26035255] 3. Food and Drug Administration. Search orphan drug designations and approvals. From FDA website. Accessed 2016 Jun 10. 4. Bristol-Myers Squibb. How to order empliciti. From Bristol-Myers Squibb for US Healthcare Professionals website. Accessed 2016 Jun 8. 5. Celgene. Revlimid (lenalidomide) capsules prescribing information. Summit, NJ; 2015 Feb. 6. Food and Drug Administration. Center for Drug Evaluation and Research. Application number 761035Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website. 7. Food and Drug Administration. Center for Drug Evaluation and Research. Application number 761035Orig1s000: Chemistry review(s). From FDA website. 8. Lonial S, Vij R, Harousseau JL et al. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J Clin Oncol . 2012; 30:1953-9. [PubMed 22547589] 9. Guo H, Cruz-Munoz ME, Wu N et al. Immune cell inhibition by SLAMF7 is mediated by a mechanism requiring src kinases, CD45, and SHIP-1 that is defective in multiple myeloma cells. Mol Cell Biol . 2015; 35:41-51. [PubMed 25312647] 10. Zonder JA, Mohrbacher AF, Singhal S et al. A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma. Blood . 2012; 120:552-9. [PubMed 22184404] 11. Collins SM, Bakan CE, Swartzel GD et al. Elotuzumab directly enhances NK cell cytotoxicity against myeloma via CS1 ligation: evidence for augmented NK cell function complementing ADCC. Cancer Immunol Immunother . 2013; 62:1841-9. [PubMed 24162108] 12. Balasa B, Yun R, Belmar NA et al. Elotuzumab enhances natural killer cell activation and myeloma cell killing through interleukin-2 and TNF-α pathways. Cancer Immunol Immunother . 2015; 64:61-73. [PubMed 25287778] 13. Berdeja J, Jagannath S, Zonder J et al. Pharmacokinetics and safety of elotuzumab combined with lenalidomide and dexamethasone in patients with multiple myeloma and various levels of renal impairment: results of a phase Ib study. Clin Lymphoma Myeloma Leuk . 2016; 16:129-38. [PubMed 26795075] 14. Richardson PG, Jagannath S, Moreau P et al. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b-2 dose-escalation study. Lancet Haematol . 2015; 2:e516-27. [PubMed 26686406] 15. Afifi S, Michael A, Lesokhin A. Immunotherapy: A new approach to treating multiple myeloma with daratumumab and elotuzumab. Ann Pharmacother . 2016; 50:555-68. [PubMed 27083916] 16. Lonial S, Kaufman J, Laubach J et al. Elotuzumab: a novel anti-CS1 monoclonal antibody for the treatment of multiple myeloma. Expert Opin Biol Ther . 2013; 13:1731-40. [PubMed 24151843] 17. Gibiansky L, Passey C, Roy A et al. Model-based pharmacokinetic analysis of elotuzumab in patients with relapsed/refractory multiple myeloma. J Pharmacokinet Pharmacodyn . 2016; 43:243-57. [PubMed 26993283] Next Interactions Print this page Add to My Med List More about Empliciti (elotuzumab) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous antineoplastics Consumer resources Empliciti Empliciti (Advanced Reading) Professional resources Empliciti (FDA) Elotuzumab (AHFS Monograph) Related treatment guides Multiple Myeloma> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Bristol-Myers Squibb Company AbbVie Inc. Drug Class Miscellaneous antineoplastics Related Drugs Multiple Myeloma dexamethasone , Decadron , Revlimid , cyclophosphamide , Cytoxan , Adriamycin , doxorubicin , Velcade , Doxil , vincristine , lenalidomide , Pomalyst , thalidomide , bortezomib , carfilzomib , Ninlaro , Kyprolis , melphalan , daratumumab , Thalomid , Dexasone , pomalidomide , carmustine , ixazomib , More... Empliciti Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } expenses
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