KYPROLIS (carfilzomib) for Injection Menu

Kd achieved SUPERIOR progression-free survival (PFS) vs Vd (Kd vs Vd study)1

9.3-month increase in median PFS

*18.7 months (Kd) vs 9.4 months (Vd); hazard ratio (Kd/Vd) = 0.53 (95% CI: 0.44-0.65); one-sided P < 0.00011

Kd = KYPROLIS® (carfilzomib) and dexamethasone; Vd = VELCADE® (bortezomib) and dexamethasone.

K + d SEE Kd RESULTS

A phase 3, randomized, open-label, multicenter superiority study compared KYPROLIS® plus dexamethasone (Kd) to bortezomib plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy. 929 patients were randomized in a 1:1 ratio to receive Kd (n = 464) for 28-day cycles or Vd (n = 465) for 21-day cycles until disease progression or unacceptable toxicity occurred. Patient stratification included prior proteasome inhibitor therapy (either bortezomib or carfilzomib, or no prior therapy), prior lines of therapy (1 vs 2 or 3), International Staging System stage (1 vs 2 or 3), and planned route of bortezomib administration, if randomized to the bortezomib group (intravenous vs subcutaneous). The primary endpoint was progression-free survival (PFS); select secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety.1,2

Adding KYPROLIS® to Rd TRIPLES your patient’s chance of achieving a complete response or better as observed in the KRd vs Rd study1,‡

>3x CR or better

32% (KRd) vs 9% (Rd)1

~9-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 = 0.00011

CR = complete response; KRd = KYPROLIS®, lenalidomide, and dexamethasone; Rd = lenalidomide and dexamethasone.

K + Rd SEE KRd RESULTS

A phase 3, randomized, open-label, multicenter superiority study evaluated KYPROLIS® in combination with lenalidomide and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. 792 patients were randomized in a 1:1 ratio (396 patients to KRd, 396 to Rd). Patients received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity occurred. KYPROLIS® was discontinued after Cycle 18. The primary endpoint was progression-free survival (PFS); select secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety.1,3

KYPROLIS® dosing:
Add K to d or Add K to Rd

Kd 56 mg/m2 therapeutic dose
KRd 27 mg/m2 therapeutic dose
See KYPROLIS® Dosing

d = dexamethasone; K = KYPROLIS®;
Rd = lenalidomide and dexamethasone.

Safety profile

of KYPROLIS® regimens
(Kd and KRd) and treatment duration

SEE SAFETY PROFILE

Amgen Assist 360™:

Here to help your patients

Amgen Assist 360<sup>TM</sup> logo SEE SUPPORT

References

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. Lancet Oncol. 2016;17(1):27-38. 3. Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372:142-152.
VELCADE® is a registered trademark of Millennium Pharmaceuticals, Inc.

Important Safety Information

Cardiac Toxicities

  • New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of KYPROLIS administration.
  • Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart KYPROLIS at 1 dose level reduction based on a benefit/risk assessment.
  • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure.
  • Patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment (including blood pressure and fluid management) prior to starting treatment with KYPROLIS and remain under close follow-up.

Acute Renal Failure

Tumor Lysis Syndrome

Pulmonary Toxicity

Pulmonary Hypertension

Dyspnea

Hypertension

Venous Thrombosis

Infusion Reactions

Hemorrhage

Thrombocytopenia

Hepatic Toxicity and Hepatic Failure

Thrombotic Microangiopathy

Posterior Reversible Encephalopathy Syndrome (PRES)

Embryo-fetal Toxicity

Adverse reactions

Please see full Prescribing Information.

Indications