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24 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 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.COMHUMIRA ONCE WEEKLYONCE WEEKLY ABBREVIATION 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.
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.COMHUMIRA ONCE WEEKLYONCE WEEKLY ABBREVIATION 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 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 here 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 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 KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Object Moved This document may be found hereCLINICAL REFERENCES
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 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 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 WWW.KYPROLIS-HCP.COMHUMIRA ONCE WEEKLYONCE WEEKLY ABBREVIATION Object Moved This document may be found here 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 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 KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Object Moved This document may be found hereCLINICAL REFERENCES
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 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 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 WWW.KYPROLIS-HCP.COMHUMIRA ONCE WEEKLYONCE WEEKLY ABBREVIATION Object Moved This document may be found here KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE KYPROLIS® (carfilzomib) for Relapsed/Refractory Multiple 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 KYPROLIS® (CARFILZOMIB) FOR RELAPSED/REFRACTORY MULTIPLE Object Moved This document may be found here 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 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 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 Comparable rates of discontinuation and number of deaths due to adverse reactions were seen between Kd and Vd 1,2. The most common reaction leading to discontinuation was cardiac failure in the Kd arm (n = 8, 2%) and peripheral neuropathy in the Vd arm (n = 22, 5%). 1 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 CRIndications
* 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
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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 = 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 = 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 dosing
Dosing and administration Kd = KYPROLIS® (carfilzomib) and dexamethasone; KRd = KYPROLIS® (carfilzomib), lenalidomide, and dexamethasone. See Kd once weekly dosing * Mechanism of action* Multiple myeloma
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PLEASE SEE THE IMPORTANT SAFETY INFORMATION IN THE SECTION BELOW.COLLAPSE__
IMPORTANT SAFETY INFORMATIONWARNING: SKIN RASH
In clinical studies, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Severe or life-threatening skin reactions have been reported. Skin reactions included (but were not limited to):* Acne-like rash
* Skin rash
* Nail infections
* Dry skin
* Redness
* Skin peeling
* Openings in the skin* Itching
percent of these patients had severe skin reactions, which involved pain, disfigurement, ulceration, or loss of outer layers of skin. Some patients who developed severe skin reactions also developed infections in the blood, skin, fat, or tissue that sometimes resulted in death. doctor may decrease your dose, delay your next dose, or stop Vectibix® treatment altogether to manage your side effects. It is important that you tell your doctor right away if you have any skin reactions or any signs of infection (such as chills, fever, or increased redness or swelling of an existing skin reaction). -------------------------RAS-MUTANT MCRC
with RAS-mutant mCRC should not take Vectibix®. Investigations of the clinical studies that used Vectibix® showed that Vectibix® exposed patients with RAS-mutant mCRC to serious side effects without workingto treat cancer.
-------------------------LOW ELECTROLYTES
patients who were taking Vectibix® developed low levels of certain electrolytes, including:* Magnesium
* Calcium
* Potassium
doctor may check the levels of these electrolytes in your blood while you are on treatment and for 2 months after you finish treatment. Your doctor may add other oral or intravenous medications to your Vectibix® treatment. -------------------------INFUSION REACTIONS
Vectibix® is given by infusion into a vein. Some patients may develop an infusion reaction, which can be severe and in rare cases has resulted in death. Infusion reactions developed in 4% of patients in one clinical trial, and 1% of patients experienced serious infusion reactions. Infusion reactions included:* Fever
* Shortness of breath * Low blood pressure* Chills
* Throat spasms
on how severe the reaction is, your doctor may decide to slow the rate of the infusion, stop the infusion, or stop your Vectibix® treatmentcompletely.
-------------------------KIDNEY PROBLEMS
Tell your doctor right away if you experience severe diarrhea or dehydration. Some patients treated with Vectibix® and chemotherapy developed kidney failure or other complications because of severe diarrhea and dehydration.LUNG PROBLEMS
Lung disease, including fatal lung disease, occurred in 1% or less of patients who had taken Vectibix®. Tell your doctor if you have problems breathing, wheezing, or a cough that doesn’t go away or keeps coming back. If you have been told that you have had lung problems in the past, be sure to tell your doctor. Your doctor may decide to stop Vectibix® treatment.AVOID SUNLIGHT
Being in the sun may make skin reactions worse. Wear sunscreen and protective clothing (like a hat), and avoid direct sunlight while you are on treatment with Vectibix®. Tell your doctor if you have new or worsening skin reactions. -------------------------EYE PROBLEMS
Inflammation of the eye and injury to the cornea have been reported. Tell your doctor if you have any vision changes or eye problems. ------------------------- DO NOT TAKE WITH AVASTIN® Patients treated with Avastin® (bevacizumab) and Vectibix® together did not live as long and had more serious side effects, such as acne-like rash, diarrhea, dehydration, painful ulcers and mouth sores, and low levels of potassium and magnesium in the blood. Some patients developed blood clots that can travel to the lungs, which can be very serious or even fatal. Do not take Avastin® with Vectibix®. -------------------------AVOID PREGNANCY
Use effective birth control to avoid pregnancy while taking Vectibix® and for 6 months after the last dose. It is possible for a pregnant patient to transfer Vectibix® to an unborn child, which could be harmful to the unborn child. -------------------------AVOID BREASTFEEDING
Vectibix® could also be transferred to a child through breast milk. Your doctor may tell you that you should not nurse your baby during Vectibix® therapy and for 2 months after your last dose ofVectibix®.
------------------------- PREGNANCY SURVEILLANCE PROGRAM Women who become pregnant during Vectibix® treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Women who are nursing during Vectibix® treatment are encouraged to enroll in Amgen’s Lactation Surveillance Program. Call 1 (800) 772-6436 toenroll.
------------------------- MOST COMMON SIDE EFFECTS In clinical studies using Vectibix® alone, the most common side effects were severe skin reactions, nail infections, lack of energy, nausea, and diarrhea. The most common serious side effects were general declining health and blockage of the bowel. In clinical studies using Vectibix® with FOLFOX, the most commonly reported side effects for wild-type KRAS patients were diarrhea, painful mouth swelling, swelling/redness of the inner lining of the mouth, lack of energy, nail infection, lack of hunger, unusual magnesium and potassium levels in the blood, rash, acne-like rash, severe itching, and dry skin. The most serious side effects reported in Vectibix®-treated wild-type KRAS patients were diarrhea anddehydration.
-------------------------TALK TO YOUR DOCTOR
Tell your doctor right away if you have any side effects such as worsening skin problems, eye problems, fever, chills, breathing problems (such as a cough that doesn’t go away or keeps coming back, wheezing, or shortness of breath), if you develop diarrhea or become dehydrated, or if you become pregnant. -------------------------OTHER MEDICATIONS
Do not change or stop any medications you may be taking (including over-the-counter drugs or supplements you can buy without a prescription) without first speaking with your doctor. Please read the full Prescribing Information and discuss it with yourdoctor.
KRD 27 MG/M2 AS A TRIPLET THERAPY* Efficacy
* KRd vs Rd study design * KRd vs Rd study results * Results by patient type* Safety
* Dosing
* KRd dosing
* Dosing and administration KD 56 MG/M2 AS A DOUBLET THERAPY* Efficacy
* Kd vs Vd study design * Kd vs Vd study results * Results by patient type* Safety
* Dosing
* Kd dosing
* Dosing and administration KD 70 MG/M2 ONCE WEEKLY* Efficacy
* Kd once weekly study design * Kd once weekly study results* Safety
* Dosing
* Kd once weekly dosing * Dosing and administration * Mechanism of action* Multiple myeloma
* Access & resources * Access & reimbursement* Resources
When multiple myeloma relapses, TAKE CONTROL WITH KYPROLIS®— TARGET THE PROTEASOME. KRD 27 MG/M2 AS A TRIPLET THERAPY 8.7-MONTH INCREASE IN MEDIAN PFSDetails
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