- KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone, or with lenalidomide plus dexamethasone, or with daratumumab plus dexamethasone, ... Read More Close
The quantity of KYPROLIS® (carfilzomib) contained in one single-dose vial (30 mg or 60 mg) may exceed the recommended dose. Caution should be used in calculating the quantity delivered to prevent overdosing.
Administer as an intravenous infusion.
KYPROLIS® vials contain no antimicrobial preservatives and are intended for single dose only. Unopened vials of KYPROLIS® are stable until the date indicated on the package when stored in the original package at 2°C to 8°C (36°F to 46°F). Retain in original package to protect from light. The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL.
Adequate hydration is required prior to KYPROLIS® dosing in Cycle 1—especially in patients at high risk of tumor lysis syndrome or renal toxicity.1
Consider hydration with both oral and IV fluids
at least 48 hours before Cycle 1, Day 1
prior to each
dose in Cycle 1
If needed, give an additional 250-500 mL of IV fluids following KYPROLIS® administration
Continue oral and/or IV hydration, as needed
Monitor patients for evidence of volume overload and adjust hydration to individual patient needs, especially in patients with, or at risk for, cardiac failure
Recommended action
Absolute neutrophil count (ANC) less than 0.5 x 109/L
Withhold dose
For subsequent drops to less than 0.5 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting KYPROLIS®*
Febrile neutropenia (ANC less than 0.5 x 109/L and an oral temperature more than 38.5°C or two consecutive readings of more than 38.0°C for 2 hours)
Withhold dose
Platelets less than 10 x 109/L or evidence of bleeding with thrombocytopenia
Withhold dose
For subsequent drops to less than 10 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting KYPROLIS®*
Recommended action
Serum creatinine greater than or equal to 2 × baseline, or
Creatinine clearance less than 15 mL/min, or creatinine clearance decreases to less than or equal to 50% of baseline, or need for hemodialysis
Withhold dose and continue monitoring renal function (serum creatinine or creatinine clearance)
If not attributable to KYPROLIS®, dosing may be resumed at the discretion of the healthcare provider
For patients on hemodialysis receiving KYPROLIS®, the dose is to be administered after the hemodialysis procedure
Recommended action
All other severe or life-threatening (Grade 3 or 4) non-hematological toxicities
Withhold until resolved or returned to baseline
Consider restarting the next scheduled treatment at 1 dose level reduction (see table below for dose level reductions)*
Dose modifications for use in hepatic impairment1
Dosing in patients with end stage renal disease1
Note: Infusion times remain unchanged during dose reduction(s).
*If toxicity persists, discontinue KYPROLIS® treatment.
ANC, absolute neutrophil count.
Please see accompanying full Prescribing Information.
Please see accompanying full Prescribing Information.
References: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Jakubowiak AJ, DeCara JM, Mezzi K. Cardiovascular events during carfilzomib therapy for relapsed myeloma: practical management aspects from two case studies. Hematology. 2017;22:585-591.