minute infusion [see Clinical Studies (14.3)]. In Cycles 1 through 12, administer Kyprolis on two consecutive days, each week for three weeks followed by a 12-day rest period as shown in Table 3. Each 28-day period is considered one treatment cycle. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis (see Table 3). Premedicate with dexamethasone 4 mg orally or intravenously 30 minutes to 4 hours before each Kyprolis dose in Cycle 1, then as needed to help prevent infusion reactions [see Dosage and Administration (2.1)]. The recommended starting dose of Kyprolis is 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 27 mg/m2 on Day 8 of Cycle 1. Treatment may continue until disease progression or unacceptable toxicity occurs.
Table 3: Kyprolis Monotherapy (10-Minute Infusion)
Dexamethasone premedication is required for each Kyprolis dose in Cycle 1
20/56 mg/m2 regimen by 30-minute infusion
For monotherapy using the 20/56 mg/m2 regimen, administer Kyprolis intravenously as a 30-minute infusion [see Clinical Studies (14.3)]. In Cycles 1 through 12, administer Kyprolis on two consecutive days, each week for three weeks followed by a 12-day rest period as shown in Table 4. Each 28-day period is considered one treatment cycle. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis (see Table 4). Premedicate with dexamethasone 8 mg orally or intravenously 30 minutes to 4 hours before each Kyprolis dose in Cycle 1, then as needed to help prevent infusion reactions [see Dosage and Administration (2.1)]. The recommended starting dose of Kyprolis is 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 56 mg/m2 on Day 8 of Cycle 1. Treatment may continue until disease progression or unacceptable toxicity occurs.
Table 4: Kyprolis Monotherapy (30-Minute Infusion)
Dexamethasone premedication is required for each Kyprolis dose in Cycle 1.
2.3 Dose Modifications Based on Toxicities
Modify dosing based on toxicity. Recommended actions and dose modifications for Kyprolis are presented in Table 5. Dose level reductions are presented in Table 6. See the lenalidomide and dexamethasone Prescribing Information respectively for dosing recommendations.
Table 5: Dose Modifications for Toxicity
during Kyprolis Treatment
ANC = absolute neutrophil count
See Table 6 for dose level reductions.
CTCAE Grades 3 and 4.
Table 6: Dose Level Reductions for Kyprolis
Note: Infusion times remain unchanged during dose reduction(s).
If toxicity persists, discontinue Kyprolis treatment.
2.4 Reconstitution and Preparation for Intravenous Administration
Kyprolis vials contain no antimicrobial preservatives and are intended for single use 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). The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL. The quantity of Kyprolis contained in one single-dose vial (60 mg carfilzomib) may exceed the required dose. Use caution in calculating the quantity delivered to prevent overdosing. Read the complete preparation instructions prior to reconstitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstitution/Preparation Steps:
1.Remove vial from refrigerator just prior to use.
2.Calculate the dose (mg/m2) and num |
