Elotuzumab

Therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. ALTERNATIVE REGIMEN - with pomalidomide and dexamethasone: elotuzumab 10 mg/kg IV weekly on days 1, 8, 15 and 22 of each 28-day cycle for the first two cycles, then 20 mg/kg on day 1 of each cycle thereafter; for the 20 mg/kg dose the infusion starts at 3 mL/min then 4 mL/min after 30 minutes (5 mL/min from dose 2 onwards), and patients already escalated to 5 mL/min at 10 mg/kg must drop back to 3 mL/min at the first 20 mg/kg infusion. MANDATORY PREMEDICATION 45-90 minutes before every elotuzumab infusion: dexamethasone 8 mg intravenous; an H1 blocker - diphenhydramine 25-50 mg orally or intravenously or equivalent; an H2 blocker - ranitidine 50 mg intravenously or 150 mg orally or equivalent; and paracetamol 650-1000 mg orally. Companion dosing in the lenalidomide regimen: lenalidomide 25 mg orally once daily on days 1-21 of each 28-day cycle, given at least 2 hours after the elotuzumab infusion when on the same day; dexamethasone 28 mg orally 3-24 hours before elotuzumab plus 8 mg intravenously 45-90 minutes before it on days 1, 8, 15 and 22, and 40 mg orally on days when elotuzumab is not given but dexamethasone is scheduled (days 8 and 22 from cycle 3). Companion dosing in the pomalidomide regimen: pomalidomide 4 mg orally once daily on days 1-21, at least 2 hours after the elotuzumab infusion on the same day; dexamethasone on elotuzumab days is 28 mg orally (patients 75 years or younger) or 8 mg orally (patients over 75) plus 8 mg intravenously, and on non-elotuzumab dexamethasone days (days 8, 15 and 22 from cycle 3) is 40 mg orally (75 or younger) or 20 mg orally (over 75). Infusion-related reactions: interrupt for any reaction of Grade 2 or higher, restart at 0.5 mL/min on resolution to Grade 1 or less and escalate by 0.5 mL/min every 30 minutes as tolerated; monitor vital signs every 30 minutes for 2 hours after the infusion ends; if the reaction recurs stop and do not restart that day; reactions of Grade 3 or higher may require permanent discontinuation and emergency treatment. If one medicine in the regimen is delayed, interrupted or discontinued the others may continue, but if dexamethasone is delayed or discontinued the decision to give elotuzumab should be based on clinical judgement (hypersensitivity risk). Hepatic impairment: no adjustment in mild impairment; not studied in moderate or severe impairment. Elderly: no adjustment over 65 years, very limited data at 85 years and over. Paediatric: there is no relevant use of elotuzumab in the paediatric population for multiple myeloma.