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B:16.75”
T:16.25”
S:14.625”
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
(20 mg/m2):
Dosing
Dosing
Dosing Dosing
a
Cycles 2 and Beyond
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 &