KYPROLIS™ (carfilzomib) for Injection
Brief Summary of Prescribing Information. Please see the KYPROLIS package insert for full
prescribing information.
INDICATIONS AND USAGE: KYPROLIS is indicated for the treatment of patients with multiple myeloma
who have received at least two prior therapies including bortezomib and an immunomodulatory agent and
have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is
based on response rate [see Clinical Studies section of full PI]. Clinical benefit, such as improvement in
survival or symptoms, has not been verified.
DOSAGE AND ADMINISTRATION: Dosing Guidelines. KYPROLIS is administered intravenously over 2 to
10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by
a 12‑day rest period (Days 17 to 28). Each 28‑day period is considered one treatment cycle (Table 1). In
Cycle 1, KYPROLIS is administered at a dose of 20 mg/m2. If tolerated in Cycle 1, the dose should be
escalated to 27 mg/m2 beginning in Cycle 2 and continued at 27 mg/m2 in subsequent cycles. Treatment
may be continued until disease progression or until unacceptable toxicity occurs [see Dosage and
Administration]. The dose is calculated using the patient’s actual body surface area at baseline. Patients with
a body surface area greater than 2.2 m2 should receive a dose based upon a body surface area of 2.2 m2.
Dose adjustments do not need to be made for weight changes of less than or equal to 20%.
Table 1: KYPROLIS Dosage Regimen for Patients with Multiple Myeloma
Cycle 1
Week 1
Week 2
Week 3
Week 4
Day Day Days Day Day Days Day Day Days Days
2
3–7
8
9
10–14 15
16 17–21 22–28
1
KYPROLIS
No
20
20 20
No
20
20
No
No
20
2):
(20 mg/m
Dosing
Dosing
Dosing Dosing
Cycles 2 and Beyonda
Week 1
Week 2
Week 3
Week 4
Day Day Days Day Day Days Day Day Days Days
2
3–7
8
9
10–14 15
16 17–21 22–28
1
KYPROLIS
27
No
27 27
No
27
27
No
No
27
Dosing
Dosing
Dosing Dosing
(27 mg/m2):
a If
previous cycle dosage is tolerated.
Hydration and Fluid Monitoring. Hydrate patients to reduce the risk of renal toxicity and of tumor lysis
syndrome (TLS) with KYPROLIS treatment [see Warnings and Precautions]. Maintain adequate fluid volume
status throughout treatment and monitor blood chemistries closely. Prior to each dose in Cycle 1, give
250 mL to 500 mL of intravenous normal saline or other appropriate intravenous fluid. Give an additional
250 mL to 500 mL of intravenous fluids as needed following KYPROLIS administration. Continue
intravenous hydration, as needed, in subsequent cycles. Also monitor patients during this period for fluid
overload [see Warnings and Precautions]. Dexamethasone Premedication. Pre‑medicate with
dexamethasone 4 mg orally or intravenously prior to all doses of KYPROLIS during Cycle 1 and prior to all
KYPROLIS doses during the first cycle of dose escalation to 27 mg/m2 to reduce the incidence and severity
of infusion reactions [see Warnings and Precautions]. Reinstate dexamethasone premedication (4 mg
orally or intravenously) if these symptoms develop or reappear during subsequent cycles. Dose
Modifications based on Toxicities. Recommended actions and dose modifications are presented
in Table 2.
Table 2: Dose Modifications for Toxicitya during KYPROLIS Treatment
Hematologic Toxicity
• Grad R6