Elotuzumab therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. 4): Dexamethasone 8 mg intravenous H1 blocker: diphenhydramine (25-50 mg orally or intravenous) or equivalent H1 blocker.
H2 blocker: ranitidine (50 mg intravenous or 150 mg orally) or equivalent H2 blocker. Paracetamol (650-1000 mg orally). Management of IRRs If a ≥ Grade 2 IRR occurs during Empliciti administration, the infusion must be interrupted. 5 mL/min every 30 minutes as tolerated to the rate at which the IRR occurred.
If there is no recurrence of the IRR, the escalation can be resumed (see Tables 3 and 4). In patients who experience an IRR, vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion. 4). Very severe IRRs (≥ Grade 3) may require permanent discontinuation of Empliciti therapy and emergency treatment.
Posology for administration with lenalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 1 for the dosing schedule. Treatment should continue until disease progression or unacceptable toxicity. The recommended dose of Empliciti is 10 mg/kg body weight (bw) administered intravenously every week, on days 1, 8, 15, and 22 for the first two treatment cycles and every 2 weeks thereafter on days 1 and 15.
The recommended dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
The administration of dexamethasone is as follows:
On days that Empliciti is administered, dexamethasone should be given as 28 mg orally once daily between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti on days 1, 8, 15, and 22 of repeated 28-day cycles.
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), dexamethasone should be given 40 mg orally.
Table 1:
Recommended dosing schedule of Empliciti in combination with lenalidomide and dexamethasone Cycle 28-Day Cycles 1 & 2 28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22 Premedication Empliciti (mg/kg bw) intravenously 10 10 10 10 10 10 Lenalidomide (25 mg) orally Days 1-21 Days 1-21 Dexamethasone (mg) orally 28 28 28 28 28 40 28 40 Day of Cycle 1 8 15 22 1 8 15 22 For additional information concerning lenalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Posology for administration with pomalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 2 for the dosing schedule. Treatment should continue until disease progression or unacceptable toxicity. The recommended dose of Empliciti is 10 mg/kg bw administered intravenously every week on days 1, 8, 15, and 22 of each treatment cycle for the first two cycles and then 20 mg/kg bw administered on day 1 of each treatment cycle thereafter.
The recommended dose of pomalidomide is 4 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day. Administration of dexamethasone for adults ≤ 75 years old and for > 75 years old On days that Empliciti is administered, patients ≤ 75 years old give dexamethasone 28 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti and for patients > 75 years old give dexamethasone 8 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, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients ≤ 75 years old and 20 mg orally to patients > 75 years old.
Table 2:
Recommended dosing schedule of Empliciti in combination with pomalidomide and dexamethasone Cycle 28-Day Cycles 1 and 2 28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22 Premedication Empliciti (mg/kg bw) intravenously 10 10 10 10 20 Cycle 28-Day Cycles 1 and 2 28-Day Cycles 3+ Pomalidomide (4 mg) orally Days 1-21 Days 1-21 Dexamethasone (mg) intravenously 8 8 8 8 8 Dexamethasone (mg) orally ≤ 75 years old 28 28 28 28 28 40 40 40 Dexamethasone (mg) orally > 75 years old 8 8 8 8 8 20 20 20 Day of Cycle 1 8 15 22 1 8 15 22 For additional information concerning pomalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
See Method of administration below for instruction on infusion rates. Dose delay, interruption, or discontinuation If the dose of one medicine in the regimen is delayed, interrupted, or discontinued, the treatment with the other medicinal products may continue as scheduled.
g. 4). 2). Data on the efficacy and safety of Empliciti in patients ≥ 85 years of age are very limited. The dose for dexamethasone in combination with pomalidomide is adjusted according to age. See Administration of dexamethasone for adults ≤ 75 years old and for > 75 years old above.
Renal impairment No dose adjustment of Empliciti is required for patients with mild (creatinine clearance (CrCl) = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl < 30 mL/min) renal […]