Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Posology The dose is calculated using the patient’s baseline body surface area (BSA). 2 m2. Dose adjustments do not need to be made for weight changes of less than or equal to 20%.
Kyprolis in combination with lenalidomide and dexamethasone When combined with lenalidomide and dexamethasone, Kyprolis is administered intravenously as a 10 minute infusion, on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28) as shown in table 1.
Each 28-day period is considered one treatment cycle. Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. If tolerated, the dose should be increased on day 8 of cycle 1 to 27 mg/m2 (maximum dose 60 mg).
From cycle 13, the day 8 and 9 doses of Kyprolis are omitted. Treatment may be continued until disease progression or until unacceptable toxicity occurs. 1). In combination with Kyprolis, lenalidomide is administered as 25 mg orally on days 1-21 and dexamethasone is administered as 40 mg orally or intravenously on days 1, 8, 15, and 22 of the 28-day cycles.
Appropriate dose reduction for the starting dose of lenalidomide should be considered according to the recommendations in the current lenalidomide summary of product characteristics, for example for patients with baseline renal impairment.
Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis. Table 1. Kyprolis in combination with lenalidomide and dexamethasone Cycle 1 Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Days 23-28 Kyprolis (mg/m2)a 20 20 - 27 27 - 27 27 - - - Dexamethasone (mg) 40 - - 40 - - 40 - - 40 - Lenalidomide 25 mg daily - - Cycles 2-12 Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Days 23-28 Kyprolis (mg/m2)a 27 27 - 27 27 - 27 27 - - - Dexamethasone (mg) 40 - - 40 - - 40 - - 40 - Lenalidomide 25 mg daily - - Cycles 13 on Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Days 23-28 Kyprolis (mg/m2)a 27 27 - - - - 27 27 - - - Dexamethasone (mg) 40 - - 40 - - 40 - - 40 - Lenalidomide 25 mg daily - - a.
Infusion time is 10 minutes and remains consistent throughout the regimen Kyprolis in combination with dexamethasone When combined with dexamethasone, Kyprolis is administered intravenously as a 30 minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 2.
Each 28-day period is considered one treatment cycle. Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg).
Treatment may be continued until disease progression or until unacceptable toxicity occurs. When Kyprolis is combined with dexamethasone alone, dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycles.
Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis. Table 2. Kyprolis in combination with dexamethasone alone Cycle 1 Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Day 23 Days 24-28 Kyprolis (mg/m2)a 20 20 - 56 56 - 56 56 - - - - Dexamethason e (mg) 20 20 - 20 20 - 20 20 - 20 20 - Cycle 2 and all subsequent cycles Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Day 23 Days 24-28 Kyprolis (mg/m2)a 56 56 - 56 56 - 56 56 - - - - Dexamethason e (mg) 20 20 - 20 20 - 20 20 - 20 20 - a.
Infusion time is 30 minutes and remains consistent throughout the regimen Kyprolis in combination with daratumumab and dexamethasone When combined with daratumumab and dexamethasone, Kyprolis is administered intravenously as a 30-minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 3.
Each 28-day period is considered one treatment cycle. Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg).
Treatment may be continued until disease progression or until unacceptable toxicity occurs. Dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15 and 16 and 40 mg orally or intravenously on day 22 of each 28 day cycle.
For patients > 75 years of age, administer 20 mg of dexamethasone orally or intravenously weekly after the first week. Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis. Daratumumab can be administered intravenously or subcutaneously.
If given intravenously, daratumumab is given at a dose of 16 mg/kg actual body weight; with a split dose of 8 mg/kg in cycle 1 on days 1 and 2. Afterwards, daratumumab is administered as 16 mg/kg once weekly on days 8, 15 and 22 of cycle 1 and days 1, 8, 15 and 22 of cycle 2, then every 2 weeks for 4 cycles (cycles 3 to 6) and then every 4 weeks for the remaining cycles or until disease progression.
Alternatively, daratumumab can be given subcutaneously at a dose of 1800 mg on days 1, 8, 15 and 22 of cycle 1 and days 1, 8, 15 and 22 of cycle 2, then every 2 weeks for 4 cycles (cycles 3 to 6) and then every 4 weeks for the […]