- KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone, or with lenalidomide plus dexamethasone, or with daratumumab plus dexamethasone, ... Read More Read Less
Please see below for answers to frequently asked questions about KYPROLIS®
Please see the Important Safety Information and full Prescribing Information.
KYPROLIS® (carfilzomib) was studied in 4 phase 3 pivotal trials: CANDOR, ENDEAVOR, ASPIRE, and A.R.R.O.W. CANDOR was a study comparing DKd to Kd twice weekly alone in patients with RMM who received 1 to 3 prior lines of therapy. ENDEAVOR was the largest head-to-head superiority study in RMM comparing 2 proteasome inhibitors (Kd vs Vd) in patients with RMM who received 1 to 3 prior lines of therapy, while ASPIRE was a superiority study comparing KRd to Rd alone in patients with RMM who received 1 to 3 prior lines of therapy. A.R.R.O.W. was a dose frequency study comparing Kd once weekly at 70 mg/m2 vs Kd twice weekly at 27 mg/m2 in patients with RMM who received 2 to 3 prior lines of therapy.1,*
*Kd 27 mg/m2 is not an FDA-approved dose for KYPROLIS®.
For DKd once weekly, KYPROLIS® is administered intravenously as a 30-minute infusion 1 day each week for 3 weeks, followed by a 13-day rest period. Tolerability is evaluated with a starting dose of 20 mg/m2 on Day 1 of Cycle 1; if tolerated, the dose is escalated to 70 mg/m2 on Day 8 of Cycle 1.1
For DKd twice weekly, KYPROLIS® is administered intravenously as a 30-minute infusion 2 days each week for 3 weeks, followed by a 12-day rest period. Tolerability is evaluated with a starting dose of 20 mg/m2 on Days 1 and 2 of Cycle 1; if tolerated, the dose is escalated to 56 mg/m2 on Day 8 of Cycle 1.1
For Kd 70 mg/m2 once weekly, KYPROLIS® is administered intravenously as a 30-minute infusion 1 day each week for 3 weeks, followed by a 13-day rest period. Tolerability is evaluated with a starting dose of 20 mg/m2 on Day 1 of Cycle 1; if tolerated, the dose is escalated to 70 mg/m2 on Day 8 of Cycle 1.1
For Kd 56 mg/m2 twice weekly, KYPROLIS® is administered intravenously as a 30-minute infusion on 2 consecutive days, each week for 3 weeks followed by a 12-day rest period. Starting dose for Kd is 20 mg/m2 in Cycle 1 on Days 1 and 2; if tolerated, the dose is escalated to 56 mg/m2 on Day 8 of Cycle 1.1
For KRd, KYPROLIS® is administered intravenously as a 10-minute infusion on 2 consecutive days, each week for 3 weeks followed by a 12-day rest period. The recommended starting dose for KRd is 20 mg/m2 in Cycle 1 on Days 1 and 2; if tolerated, the dose is escalated to 27 mg/m2 on Day 8 of Cycle 1.1
Please refer to the full Prescribing Information for complete dosing and administration information including reconstitution, dose adjustments, and monitoring requirements.
*Once-weekly dosing was demonstrated in the EQUULEUS study, a phase 1b, open-label, multi-cohort study (N = 85) which evaluated the combination of once weekly KYPROLIS® with IV daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma who received 1 to 3 prior lines of therapy. KYPROLIS® was administered weekly on Days 1, 8, and 15 of each 28-day cycle at a dose of 70 mg/m2 with a priming dose of 20 mg/m2 on Day 1 of Cycle 1. Safety and tolerability of DKd were evaluated as primary endpoints. Results from the EQUULEUS study set a precedent of DKd regimen safety and efficacy for the phase 3 CANDOR study and provided the rationale for the once weekly dosing of DKd.1,2
Once-weekly dosing was demonstrated in the EQUULEUS study, a phase 1b, open-label, multi-cohort study (N = 85) which evaluated the combination of once weekly KYPROLIS® with IV daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma who received 1 to 3 prior lines of therapy. KYPROLIS® was administered weekly on Days 1, 8, and 15 of each 28-day cycle at a dose of 70 mg/m2 with a priming dose of 20 mg/m2 on Day 1 of Cycle 1. Safety and tolerability of DKd were evaluated as primary endpoints. Results from the EQUULEUS study set a precedent of DKd regimen safety and efficacy for the phase 3 CANDOR study and provided the rationale for the once weekly dosing of DKd.1,2
Reconstituted KYPROLIS® (carfilzomib) is stable at room temperature 15°C to 30°C (59°F to 86°F) for 4 hours and when refrigerated 2°C to 8°C (36°F to 46°F) for 24 hours in the vial, syringe, or intravenous bag of 5% Dextrose Injection, USP. Total time from reconstitution to administration should not exceed 24 hours.1
Please refer to the full Prescribing Information for complete information about the stability of KYPROLIS® (carfilzomib).
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CANDOR = A randomized, open-label, phase 3 study comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma; ENDEAVOR = randomized, open label, phase 3 study of carfilzomib plus dexamethasone vs bortezomib plus dexamethasone in patients with relapsed multiple myeloma; ASPIRE = carfilzomib, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone for the treatment of patIents with relapsed multiple myeloma; A.R.R.O.W. = randomized, open-label, phase 3 study in subjects with relapsed and refractory multiple myeloma receiving carfilzomib in combination with dexamethasone, comparing once-weekly versus twice-weekly carfilzomib dosing; DKd = carfilzomib + daratumumab + dexamethasone; Kd = carfilzomib + dexamethasone; Vd = bortezomib + dexamethasone; KRd = carfilzomib + lenalidomide + dexamethasone; Rd = lenalidomide + dexamethasone; IV = intravenous.
Please see accompanying full Prescribing Information.
Please see accompanying full Prescribing Information.
References: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17:27-38. 3. Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372:142-152. 4. Moreau P, Mateos M-V, Berenson JR, et al. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018;19:953-964. 5. Chari A, Martinez-Lopez J, Mateos MV, et al. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019;134:421-431.