Ne
w
RESPOND
In
dic
at
ion
with the power of significantly
improved progression-free survival (PFS)
Posterior Reversible Encephalopathy Syndrome (PRES):
Cases of PRES have occurred in patients receiving Kyprolis. PRES
was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuro-radiological imaging (MRI) for onset
of visual or neurological symptoms. Discontinue Kyprolis if PRES is
suspected and evaluate. The safety of reinitiating Kyprolis therapy in
patients previously experiencing PRES is not known.
The KYPROLIS regimen significantly
improved PFS in patients with
relapsed multiple myeloma1
Embryo-fetal Toxicity: Kyprolis can cause fetal harm when
administered to a pregnant woman based on its mechanism of action
and findings in animals.
In the ASPIRE study of KYPROLIS + lenalidomide + low-dose
dexamethasone (KRd) vs lenalidomide + low-dose dexamethasone
(Rd), the KYPROLIS regimen delivered improved efficacy with a safety
profile comparable to Rd.1,2*
Females of reproductive potential should be advised to avoid becoming
pregnant while being treated with Kyprolis and the potential hazard to
the fetus if Kyprolis is used during pregnancy.
26.3 months median progression-free
ADVERSE REACTIONS
The most common adverse events occurring in at least 20% of patients
treated with Kyprolis in the combination therapy trial: decreased
lymphocytes, decreased absolute neutrophil count, decreased
phosphorus, anemia, neutropenia, decreased total white blood cell
count, decreased platelets, diarrhea, fatigue, thrombocytopenia,
pyrexia, muscle spasm, cough, upper respiratory tract infection,
decreased hemoglobin, hypokalemia.
References: 1. KYPROLIS [prescribing information]. Thousand Oaks, CA: Onyx Pharmaceuticals, Inc.,
an Amgen Inc. subsidiary; 2015. 2. Stewart AK, Rajkumar SV, Dimopoulos MA, et al; for the
ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma.
N Engl J Med. 2015;372(2):142-152.
Please see Brief Summary of full Prescribing Information
on adjacent pages.
survival with the KYPROLIS regimen vs
17.6 months with Rd, a 49% improvement
over Rd (P value [two-sided] 0.0001)1
Find out more at www.kyprolis.com/hcp
*ASPIRE was a global, multicenter, open-label, randomized phase 3 pivotal trial evaluating KYPROLIS
in patients with relapsed multiple myeloma. 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.1,2 The primary endpoint was progression-free survival.
Secondary endpoints included overall survival, overall response rate (partial response or better),
duration of response, and safety.2