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CLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory PATIENT COVERAGE & COST INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 KD ONCE WEEKLY DOSING KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory WWW.KYPROLIS-HCP.COM Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
KD TWICE WEEKLY SAFETY PROFILE 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.
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractoryCLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory PATIENT COVERAGE & COST INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 KD ONCE WEEKLY DOSING KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory WWW.KYPROLIS-HCP.COM Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
KD TWICE WEEKLY SAFETY PROFILE 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.
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory WWW.KYPROLIS-HCP.COM Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
KD VS VD STUDY RESULTS & EFFICACY Post hoc analysis: Demonstration of PFS by frailty status was not a study objective. This study was not powered to evaluate PFS efficacy within this subgroup. † Overall median follow-up for patients in the Kd vs Vd study was approximately 37 months. 1 Kd = KYPROLIS ® +dexamethasone; mPFS = median progression-free survival; Vd = Velcade (bortezomib)+dexamethasone; ECOG PS = Eastern KD ONCE WEEKLY RESULTS & EFFICACY Kd 70 mg/m 2 once weekly vs Kd 27 mg/m 2 twice weekly study: A phase 3, randomized, multicenter, open-label study (N = 478) in patients with relapsed and refractory multiple myeloma who had received 2 to 3 lines of therapy, KYPROLIS ® and dexamethasone 70 mg/m 2 once weekly (n = 240) versus KYPROLIS ® and dexamethasone 27 mg/m 2 twice weekly (n = 238). The primary endpoint was PFS. STUDY RESULTS FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE *ORR was defined as proportion of patients with PR or better. 4 MRD-negative CR (at the 10-5 level) is defined as achievement of CR per the IMWG-URC and MRD-negative status as assessed by the next generation sequencing assay (ClonoSEQ) at the 12 months landmark (from 8 months to 13 months window). 3 ‡ Based on sensitivity limits of detecting < 1 in 10 4 to 10 6 cells for MRD-negative CR KD ONCE WEEKLY CLINICAL STUDY DESIGN 1. KYPROLIS ® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. 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. COMBINATION DOSING FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE *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 aKRD SAFETY PROFILE
Deaths due to adverse reactions within 30 days of the last dose of any therapy in the KRd arm occurred in 12% of patients compared with 11% of patients in the Rd arm 1; The causes of death in patients in the 2 arms (KRd vs Rd) included (n, %): infection (12, 3% vs 11, 3%), cardiac (10, 3% vs 9, 2%), and other adverse reactions (23, 6% vs 22, 6%) 1 Dose reductions due to adverse reactions: In STUDY DESIGN FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE 1. KYPROLIS ® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Dimopoulos M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. MULTIPLE MYELOMA DISEASE TRAJECTORY KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd.CLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractoryDOSE MODIFICATIONS
Step 1. Remove vial from refrigerator just prior to use. 1 Step 2. Calculate the dose (mg/m 2) and number of vials of KYPROLIS ® required using the patient’s body surface area (BSA) at baseline. Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2.Dose adjustments do not need to be made for weight changes of less than or equal to 20%. 1 KD ONCE WEEKLY CLINICAL STUDY DESIGN 1. KYPROLIS ® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. 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. KD VS VD CLINICAL STUDY DESIGN KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KD TWICE WEEKLY SAFETY PROFILE 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.
STUDY RESULTS FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE *ORR was defined as proportion of patients with PR or better. 4 MRD-negative CR (at the 10-5 level) is defined as achievement of CR per the IMWG-URC and MRD-negative status as assessed by the next generation sequencing assay (ClonoSEQ) at the 12 months landmark (from 8 months to 13 months window). 3 ‡ Based on sensitivity limits of detecting < 1 in 10 4 to 10 6 cells for MRD-negative CR KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd.CLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractoryDOSE MODIFICATIONS
Step 1. Remove vial from refrigerator just prior to use. 1 Step 2. Calculate the dose (mg/m 2) and number of vials of KYPROLIS ® required using the patient’s body surface area (BSA) at baseline. Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2.Dose adjustments do not need to be made for weight changes of less than or equal to 20%. 1 KD ONCE WEEKLY CLINICAL STUDY DESIGN 1. KYPROLIS ® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. 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. KD VS VD CLINICAL STUDY DESIGN KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KD TWICE WEEKLY SAFETY PROFILE 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.
STUDY RESULTS FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE *ORR was defined as proportion of patients with PR or better. 4 MRD-negative CR (at the 10-5 level) is defined as achievement of CR per the IMWG-URC and MRD-negative status as assessed by the next generation sequencing assay (ClonoSEQ) at the 12 months landmark (from 8 months to 13 months window). 3 ‡ Based on sensitivity limits of detecting < 1 in 10 4 to 10 6 cells for MRD-negative CR KD ONCE WEEKLY DOSING Adequate hydration is required prior to dosing in Cycle 1, especially in patients at high risk of tumor lysis syndrome or renal toxicity. The recommended hydration includes both oral fluids (30 mL per kg at least 48 hours before Cycle 1, Day 1) and IV fluids (250 mL to KD ONCE WEEKLY RESULTS & EFFICACY Kd 70 mg/m 2 once weekly vs Kd 27 mg/m 2 twice weekly study: A phase 3, randomized, multicenter, open-label study (N = 478) in patients with relapsed and refractory multiple myeloma who had received 2 to 3 lines of therapy, KYPROLIS ® and dexamethasone 70 mg/m 2 once weekly (n = 240) versus KYPROLIS ® and dexamethasone 27 mg/m 2 twice weekly (n = 238). The primary endpoint was PFS. PATIENT COVERAGE & COST INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Symptomatic ischemia. DKd = KYPROLIS ® +Darzalex ® (daratumumab) and dexamethasone; Kd = KYPROLIS ® +dexamethasone; IV = intravenous; PO = per os (by mouth); MRD = minimal residual disease; CR = complete response; PR = partial response; ECOG PS = Eastern Cooperative Oncology Group Performance Status; CrCl = creatinine clearance; LVEF =left
RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult p KD VS VD STUDY RESULTS & EFFICACY Post hoc analysis: Demonstration of PFS by frailty status was not a study objective. This study was not powered to evaluate PFS efficacy within this subgroup. † Overall median follow-up for patients in the Kd vs Vd study was approximately 37 months. 1 Kd = KYPROLIS ® +dexamethasone; mPFS = median progression-free survival; Vd = Velcade (bortezomib)+dexamethasone; ECOG PS = Eastern KRD VS RD STUDY RESULTS & EFFICACY Post hoc analysis: Demonstration of PFS by frailty status was not a study objective. This study was not powered to evaluate PFS efficacy within this subgroup. † Overall median follow-up for patients in the KRd vs Rd study was approximately 67 months. 1 KRd = KYPROLIS ® +lenalidomide and dexamethasone; mPFS = median progression-free survival; Rd = lenalidomide+dexamethasone; ECOG PS STUDY DESIGN FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE 1. KYPROLIS ® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Dimopoulos M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study.KRD SAFETY PROFILE
Deaths due to adverse reactions within 30 days of the last dose of any therapy in the KRd arm occurred in 12% of patients compared with 11% of patients in the Rd arm 1; The causes of death in patients in the 2 arms (KRd vs Rd) included (n, %): infection (12, 3% vs 11, 3%), cardiac (10, 3% vs 9, 2%), and other adverse reactions (23, 6% vs 22, 6%) 1 Dose reductions due to adverse reactions: In KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory WWW.KYPROLIS-HCP.COM Kd once-weekly dosing schedule 1. Administer a priming dose of KYPROLIS ® (20 mg/m 2) on Day 1 of Cycle 1 as a 30-minute intravenous infusion to evaluate tolerability to treatment with KYPROLIS ®. Target the therapeutic dose of KYPROLIS ® (70 mg/m 2) starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1. WWW.KYPROLIS-HCP.COM Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
HCP FAQS | KYPROLIS® (CARFILZOMIB) 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 RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 KD TWICE WEEKLY SAFETY PROFILE 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.
KD VS VD STUDY RESULTS & EFFICACY Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory WWW.KYPROLIS-HCP.COM Kd once-weekly dosing schedule 1. Administer a priming dose of KYPROLIS ® (20 mg/m 2) on Day 1 of Cycle 1 as a 30-minute intravenous infusion to evaluate tolerability to treatment with KYPROLIS ®. Target the therapeutic dose of KYPROLIS ® (70 mg/m 2) starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1. WWW.KYPROLIS-HCP.COM Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
HCP FAQS | KYPROLIS® (CARFILZOMIB) 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 RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 KD TWICE WEEKLY SAFETY PROFILE 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.
KD VS VD STUDY RESULTS & EFFICACY Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
MULTIPLE MYELOMA DISEASE TRAJECTORY KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 PATIENT COVERAGE & COST INFORMATION Patient Coverage & Cost Information | KYPROLIS® (carfilzomib) Indications. KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to threelines
DOSE MODIFICATIONS
Step 1. Remove vial from refrigerator just prior to use. 1 Step 2. Calculate the dose (mg/m 2) and number of vials of KYPROLIS ® required using the patient’s body surface area (BSA) at baseline. Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2.Dose adjustments do not need to be made for weight changes of less than or equal to 20%. 1 KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS® (carfilzomib) for Relapsed/Refractory Multiple DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult p KD VS VD STUDY RESULTS & EFFICACY Post hoc analysis: Demonstration of PFS by frailty status was not a study objective. This study was not powered to evaluate PFS efficacy within this subgroup. † Overall median follow-up for patients in the Kd vs Vd study was approximately 37 months. 1 Kd = KYPROLIS ® +dexamethasone; mPFS = median progression-free survival; Vd = Velcade (bortezomib)+dexamethasone; ECOG PS = Eastern STUDY DESIGN FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE 1. KYPROLIS ® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Dimopoulos M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. STUDY RESULTS FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE *ORR was defined as proportion of patients with PR or better. 4 MRD-negative CR (at the 10-5 level) is defined as achievement of CR per the IMWG-URC and MRD-negative status as assessed by the next generation sequencing assay (ClonoSEQ) at the 12 months landmark (from 8 months to 13 months window). 3 ‡ Based on sensitivity limits of detecting < 1 in 10 4 to 10 6 cells for MRD-negative CR WWW.KYPROLIS-HCP.COM Symptomatic ischemia. DKd = KYPROLIS ® +Darzalex ® (daratumumab) and dexamethasone; Kd = KYPROLIS ® +dexamethasone; IV = intravenous; PO = per os (by mouth); MRD = minimal residual disease; CR = complete response; PR = partial response; ECOG PS = Eastern Cooperative Oncology Group Performance Status; CrCl = creatinine clearance; LVEF =left
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult p WWW.KYPROLIS-HCP.COM Kd once-weekly dosing schedule 1. Administer a priming dose of KYPROLIS ® (20 mg/m 2) on Day 1 of Cycle 1 as a 30-minute intravenous infusion to evaluate tolerability to treatment with KYPROLIS ®. Target the therapeutic dose of KYPROLIS ® (70 mg/m 2) starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1. KD ONCE WEEKLY DOSING KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KD VS VD CLINICAL STUDY DESIGN KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KD VS VD STUDY RESULTS & EFFICACY Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
KD TWICE WEEKLY SAFETY PROFILE 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.
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. CARFILZOMIB MECHANISM OF ACTION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult p WWW.KYPROLIS-HCP.COM Kd once-weekly dosing schedule 1. Administer a priming dose of KYPROLIS ® (20 mg/m 2) on Day 1 of Cycle 1 as a 30-minute intravenous infusion to evaluate tolerability to treatment with KYPROLIS ®. Target the therapeutic dose of KYPROLIS ® (70 mg/m 2) starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1. KD ONCE WEEKLY DOSING KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KD VS VD CLINICAL STUDY DESIGN KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KD VS VD STUDY RESULTS & EFFICACY Kd = KYPROLIS ® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE ® (bortezomib) and dexamethasone. Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd 3. Progression-free survival at24 months 1,3.
KD TWICE WEEKLY SAFETY PROFILE 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.
DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult pCLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
DOSE MODIFICATIONS
Step 1. Remove vial from refrigerator just prior to use. 1 Step 2. Calculate the dose (mg/m 2) and number of vials of KYPROLIS ® required using the patient’s body surface area (BSA) at baseline. Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2.Dose adjustments do not need to be made for weight changes of less than or equal to 20%. 1 KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Safety experience with DKd vs Kd 1. Fatal adverse reactions within 30 days of the last dose of any study treatment occurred in 10% of 308 patients in the DKd arm compared with 5% of 153 patients in the Kd arm 1. The most frequent fatal adverse reaction that occurred in patients in the 2 arms (DKd vs Kd) was infections (4.5% vs 2.6%) 1. MULTIPLE MYELOMA DISEASE TRAJECTORY KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory RESULTS BY PATIENT TYPE KYPROLIS ®-based regimens (KRd and Kd) demonstrated superior median progression-free survival vs Rd and Vd, respectively 5, †,‡ KRd 27 mg/m 2 as a triplet therapy 8.7-month increase in median PFS: 26.3 months (KRd) vs 17.6 months (Rd); hazard ratio (KRd/Rd) = 0.69 (95% CI: 0.57-0.83); two-sided P = 0.0001 5 ‡ Kd 56 mg/m 2 as a doublet therapy 9.3-month increase in median PFS: 18.7 PATIENT COVERAGE & COST INFORMATION Patient Coverage & Cost Information | KYPROLIS® (carfilzomib) Indications. KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to threelines
WWW.KYPROLIS-HCP.COM Symptomatic ischemia. DKd = KYPROLIS ® +Darzalex ® (daratumumab) and dexamethasone; Kd = KYPROLIS ® +dexamethasone; IV = intravenous; PO = per os (by mouth); MRD = minimal residual disease; CR = complete response; PR = partial response; ECOG PS = Eastern Cooperative Oncology Group Performance Status; CrCl = creatinine clearance; LVEF =left
KD ONCE WEEKLY RESULTS & EFFICACY Kd 70 mg/m 2 once weekly vs Kd 27 mg/m 2 twice weekly study: A phase 3, randomized, multicenter, open-label study (N = 478) in patients with relapsed and refractory multiple myeloma who had received 2 to 3 lines of therapy, KYPROLIS ® and dexamethasone 70 mg/m 2 once weekly (n = 240) versus KYPROLIS ® and dexamethasone 27 mg/m 2 twice weekly (n = 238). The primary endpoint was PFS. KD VS VD STUDY RESULTS & EFFICACY Post hoc analysis: Demonstration of PFS by frailty status was not a study objective. This study was not powered to evaluate PFS efficacy within this subgroup. † Overall median follow-up for patients in the Kd vs Vd study was approximately 37 months. 1 Kd = KYPROLIS ® +dexamethasone; mPFS = median progression-free survival; Vd = Velcade (bortezomib)+dexamethasone; ECOG PS = Eastern KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractoryCLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult p WWW.KYPROLIS-HCP.COM Kd once-weekly dosing schedule 1. Administer a priming dose of KYPROLIS ® (20 mg/m 2) on Day 1 of Cycle 1 as a 30-minute intravenous infusion to evaluate tolerability to treatment with KYPROLIS ®. Target the therapeutic dose of KYPROLIS ® (70 mg/m 2) starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1. MULTIPLE MYELOMA DISEASE TRAJECTORY KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory PATIENT COVERAGE & COST INFORMATION Patient Coverage & Cost Information | KYPROLIS® (carfilzomib) Indications. KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to threelines
WWW.KYPROLIS-HCP.COM Symptomatic ischemia. DKd = KYPROLIS ® +Darzalex ® (daratumumab) and dexamethasone; Kd = KYPROLIS ® +dexamethasone; IV = intravenous; PO = per os (by mouth); MRD = minimal residual disease; CR = complete response; PR = partial response; ECOG PS = Eastern Cooperative Oncology Group Performance Status; CrCl = creatinine clearance; LVEF =left
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS® (carfilzomib) for Relapsed/Refractory Multiple KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Administer KYPROLIS ® (27 mg/m 2) as a 10-minute intravenous infusion on 2 consecutive days each week for 3 weeks followed by a 12-day rest period as part of a 28-day treatment cycle. For Cycles 13-18, omit the Day 8 and 9 doses of KYPROLIS ®. KYPROLIS ® should be discontinued after Cycle 18 when given in combination with Rd. KRD DOSING INFORMATION KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractoryCLINICAL REFERENCES
Cancer Res. 2007;67:1783-1792. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia.2017;31:115-122.
WWW.KYPROLIS-HCP.COM Kd once-weekly dosing schedule 1. Administer a priming dose of KYPROLIS ® (20 mg/m 2) on Day 1 of Cycle 1 as a 30-minute intravenous infusion to evaluate tolerability to treatment with KYPROLIS ®. Target the therapeutic dose of KYPROLIS ® (70 mg/m 2) starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1. DOSING - KYPROLIS-HCP.COM KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult p MULTIPLE MYELOMA DISEASE TRAJECTORY KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory PATIENT COVERAGE & COST INFORMATION Patient Coverage & Cost Information | KYPROLIS® (carfilzomib) Indications. KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to threelines
WWW.KYPROLIS-HCP.COM Symptomatic ischemia. DKd = KYPROLIS ® +Darzalex ® (daratumumab) and dexamethasone; Kd = KYPROLIS ® +dexamethasone; IV = intravenous; PO = per os (by mouth); MRD = minimal residual disease; CR = complete response; PR = partial response; ECOG PS = Eastern Cooperative Oncology Group Performance Status; CrCl = creatinine clearance; LVEF =left
KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS® (carfilzomib) for Relapsed/Refractory Multiple KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Safety experience with DKd vs Kd 1. Fatal adverse reactions within 30 days of the last dose of any study treatment occurred in 10% of 308 patients in the DKd arm compared with 5% of 153 patients in the Kd arm 1. The most frequent fatal adverse reaction that occurred in patients in the 2 arms (DKd vs Kd) was infections (4.5% vs 2.6%) 1. KD ONCE WEEKLY DOSING KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractoryDOSE MODIFICATIONS
Step 1. Remove vial from refrigerator just prior to use. 1 Step 2. Calculate the dose (mg/m 2) and number of vials of KYPROLIS ® required using the patient’s body surface area (BSA) at baseline. Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2.Dose adjustments do not need to be made for weight changes of less than or equal to 20%. 1 KD VS VD CLINICAL STUDY DESIGN KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.; KYPROLIS ® is indicated as a single agent for the treatment of adult patients with relapsed or refractory KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS® (carfilzomib) for Relapsed/Refractory MultipleKRD SAFETY PROFILE
Deaths due to adverse reactions within 30 days of the last dose of any therapy in the KRd arm occurred in 12% of patients compared with 11% of patients in the Rd arm 1; The causes of death in patients in the 2 arms (KRd vs Rd) included (n, %): infection (12, 3% vs 11, 3%), cardiac (10, 3% vs 9, 2%), and other adverse reactions (23, 6% vs 22, 6%) 1 Dose reductions due to adverse reactions: In KD ONCE WEEKLY SAFETY PROFILE Safety profile Additional safety and clinical considerations 2. The once-weekly dose of Kd 70 mg/m 2 did not reveal any new cardiovascular safety risks 1; The overall incidence of cardiac failure events was 3.8% in the Kd 70 mg/m 2 once weekly arm versus 5.1% in the Kd 27 mg/m 2 twice weekly arm 1; The frequency of Grade ≥ 3 cardiac failure events was observed in 3% of Kd 70 mg/m 2 once KD TWICE WEEKLY SAFETY PROFILE Additional safety and clinical considerations 1,2. The overall incidence of cardiac failure events was 11% in the Kd arm versus 3% in the Vd arm 1. The frequency of Grade ≥ 3 cardiac failure events was observed in 5% of Kd patients 2. Death due to cardiac issues occurred STUDY RESULTS FOR KYPROLIS® + DARZALEX® + DEXAMETHASONE *ORR was defined as proportion of patients with PR or better. 4 MRD-negative CR (at the 10-5 level) is defined as achievement of CR per the IMWG-URC and MRD-negative status as assessed by the next generation sequencing assay (ClonoSEQ) at the 12 months landmark (from 8 months to 13 months window). 3 ‡ Based on sensitivity limits of detecting < 1 in 10 4 to 10 6 cells for MRD-negative CR KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Object Moved This document may be found hereWELCOME!
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COVID-19: Amgen is committed to keeping our patients, customers, staff and their families safe. Click here for more information.Indications
* KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. * KYPROLIS® is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.... Read More
* Prescribing Information* Indications
* Important Safety Information* References
* FAQ
Visit Patient Site
* Prescribing Info
* Indications
* Efficacy
Kd once weekly study Kd once weekly study designStudy design Kd once weekly study resultsStudy resultsKd vs Vd study
Kd vs Vd study designStudy design Kd vs Vd study resultsStudy results Results by patient typeKRd vs Rd study
KRd vs Rd study designStudy design KRd vs Rd study resultsStudy results Results by patient type Kd 70 mg/m2 once weekly vs Kd 27 mg/m2 twice weekly. Kd 27 mg/m2 is not an FDA-approved dose for KYPROLIS®.1 Kd = KYPROLIS® (carfilzomib) and dexamethasone; KRd = KYPROLIS® (carfilzomib), lenalidomide, and dexamethasone; Rd = lenalidomide and dexamethasone; Vd = VELCADE® (bortezomib) and dexamethasone.* Safety
Safety
Safety: Kd once weekly study Safety: Kd vs Vd study Safety: KRd vs Rd study Kd 70 mg/m2 once weekly vs Kd 27 mg/m2 twice weekly. Kd 27 mg/m2 is not an FDA-approved dose for KYPROLIS®.1 Kd = KYPROLIS® (carfilzomib) and dexamethasone; KRd = KYPROLIS® (carfilzomib), lenalidomide, and dexamethasone; Rd = lenalidomide and dexamethasone; Vd = VELCADE® (bortezomib) and dexamethasone. See Kd once weekly safety* Dosing
Dosing
Kd once weekly dosingKRd dosing
Kd twice weekly dosing Administration and dose modifications Kd = KYPROLIS® (carfilzomib) and dexamethasone; KRd = KYPROLIS® (carfilzomib), lenalidomide, and dexamethasone. See Kd once weekly dosing * Mechanism of action* Multiple myeloma
* Access & resourcesAccess & resources
Access & reimbursement Frequently asked questionsResources
Resources for you and your patients * Important Safety Information* References
* FAQ
__
When multiple myeloma relapses,Look to KYPROLIS®
for the way forward
KRD AS A TRIPLET THERAPY* Efficacy
* KRd vs Rd study design * KRd vs Rd study results * Results by patient type* Safety
* Dosing
* KRd dosing
* Administration and dose modifications__
Kd 70 mg/m2 once weekly vs Kd 27 mg/m2 twice weekly. Kd 27 mg/m2 is not an FDA-approved dose for KYPROLIS®.1 Kd = KYPROLIS® (carfilzomib) and dexamethasone; KRd = KYPROLIS® (carfilzomib), lenalidomide, and dexamethasone; Rd = lenalidomide and dexamethasone; Vd = VELCADE® (bortezomib) and dexamethasone. KD AS A DOUBLET THERAPY* Efficacy
* Kd once weekly study design * Kd once weekly study results * Kd vs Vd study design * Kd vs Vd study results * Results by patient type* Safety
* Kd once weekly safety profile * Kd vs Vd safety profile* Dosing
* Kd once weekly dosing * Kd twice weekly dosing * Administration and dose modifications * Mechanism of action* Multiple myeloma
* Access & resources * Access & reimbursement* Resources
* Frequently asked questionsFIND THE RIGHT DOSE
__Explore dosing
MECHANISM OF ACTION
LEARN ABOUT PROTEASOME INHIBITIONDiscover now
ACCESS & RESOURCES
HERE TO HELP YOU AND YOUR PATIENTSFind out more
REFERENCES
1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. VELCADE® (bortezomib) is a product of Millennium Pharmaceuticals.See More
IMPORTANT SAFETY INFORMATION FOR KYPROLISCARDIAC TOXICITIES
* New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration. * Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment. * While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate. * For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.ACUTE RENAL FAILURE
* Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate. TUMOR LYSIS SYNDROME * Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold untilresolved.
PULMONARY TOXICITY
* Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue KYPROLIS. PULMONARY HYPERTENSION * Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.DYSPNEA
* Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.HYPERTENSION
* Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.VENOUS THROMBOSIS
* Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks. * Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment.INFUSION REACTIONS
* Infusion reactions, including life-threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if theyoccur.
HEMORRHAGE
* Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.THROMBOCYTOPENIA
* KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate. HEPATIC TOXICITY AND HEPATIC FAILURE * Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate. THROMBOTIC MICROANGIOPATHY * Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known. POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES) * Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known. INCREASED FATAL AND SERIOUS TOXICITIES IN COMBINATION WITH MELPHALAN AND PREDNISONE IN NEWLY DIAGNOSED TRANSPLANT-INELIGIBLE PATIENTS * In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma. EMBRYO-FETAL TOXICITY * KYPROLIS can cause fetal harm when administered to a pregnantwoman.
* Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.ADVERSE REACTIONS
* The most common adverse reactions in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia. * The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral. PLEASE SEE FULL PRESCRIBING INFORMATION.
INDICATIONS
* KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. * KYPROLIS® is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.See More
IMPORTANT SAFETY INFORMATION FOR KYPROLISCARDIAC TOXICITIES
* New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration. * Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment. * While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate. * For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.ACUTE RENAL FAILURE
* Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate. TUMOR LYSIS SYNDROME * Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold untilresolved.
PULMONARY TOXICITY
* Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue KYPROLIS. PULMONARY HYPERTENSION * Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.DYSPNEA
* Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.HYPERTENSION
* Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.VENOUS THROMBOSIS
* Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks. * Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment.INFUSION REACTIONS
* Infusion reactions, including life-threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if theyoccur.
HEMORRHAGE
* Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.THROMBOCYTOPENIA
* KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate. HEPATIC TOXICITY AND HEPATIC FAILURE * Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate. THROMBOTIC MICROANGIOPATHY * Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known. POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES) * Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known. INCREASED FATAL AND SERIOUS TOXICITIES IN COMBINATION WITH MELPHALAN AND PREDNISONE IN NEWLY DIAGNOSED TRANSPLANT-INELIGIBLE PATIENTS * In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma. EMBRYO-FETAL TOXICITY * KYPROLIS can cause fetal harm when administered to a pregnantwoman.
* Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.ADVERSE REACTIONS
* The most common adverse reactions in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia. * The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral. PLEASE SEE FULL PRESCRIBING INFORMATION.
INDICATIONS
* KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. * KYPROLIS® is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.Back To Top
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