ASH Clinical News May 2015 | Page 2
THE POWER OF SECOND-GENERATION PROTEASOME INHIBITION:
SHAPING THE WAY FORWARD
Indication
Kyprolis® (carfilzomib) for Injection is indicated for the treatment
of patients with multiple myeloma who have received at least 2
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. Clinical benefit, such as improvement in survival
or symptoms, has not been verified.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
The safety of KYPROLIS was evaluated in clinical studies of
526 patients with relapsed and/or refractory multiple myeloma.
Cardiac Arrest, Congestive Heart Failure, Myocardial
Ischemia: Death due to cardiac arrest has occurred within
a day of KYPROLIS administration. New onset or worsening
of pre-existing congestive heart failure with decreased left
ventricular function or myocardial ischemia have occurred
following administration of KYPROLIS. Cardiac failure events
(e.g., cardiac failure congestive, pulmonary edema, ejection
fraction decreased) were reported in 7% of patients. Monitor
Onyx, Onyx Pharmaceuticals,
Onyx Pharmaceuticals logo, Kyprolis,
and Kyprolis logo are all trademarks
of Onyx Pharmaceuticals, Inc.
©2014 Onyx Pharmaceuticals, Inc.,
South San Francisco, CA
TROPIC-KYPR-100826J November 2014
Printed in USA
for cardiac complications and manage promptly. Withhold
KYPROLIS for Grade 3 or 4 cardiac events until recovery and
consider whether to restart KYPROLIS based on a benefit/risk
assessment. Patients with New York Heart Association Class
III and IV heart failure, myocardial infarction in the preceding
6 months, and conduction abnormalities uncontrolled by
medications may be at greater risk for cardiac complications.
Pulmonary Hypertension: Pulmonary arterial hypertension
(PAH) was reported in 2% of patients treated with KYPROLIS
and was Grade 3 or greater in less than 1% of patients. Evaluate
with cardiac imaging and/or other tests as indicated. Withhold
KYPROLIS for pulmonary hypertension until resolved or
returned to baseline and consider whether to restart KYPROLIS
based on a benefit/risk assessment.
Pulmonary Complications: Dyspnea was reported in 35% of
patients enrolled in clinical trials. Grade 3 dyspnea occurred
in 5%; no Grade 4 events, and 1 death (Grade 5) was reported.
Monitor and manage dyspnea immediately; interrupt KYPROLIS
until symptoms have resolved or returned to baseline.
Infusion Reactions: Infusion reactions were characterized
by a spectrum of systemic symptoms including fever, chills,
arthralgia, myalgia, facial flushing, facial edema, vomiting,
weakness, shortness of breath, hypotension, syncope, chest
tightness, or angina. These reactions can occur immediately
following infusion or up to 24 hours after administration of
KYPROLIS. Administer dexamethasone prior to KYPROLIS to
reduce the incidence and severity of reactions. Inform patients
of the risk and symptoms, and to contact physician if symptoms
of an infusion reaction occur.
Tumor Lysis Syndrome: Tumor lysis syndrome (TLS) occurred
following KYPROLIS administration in < 1% of patients. Patients
with multiple myeloma and a high tumor burden should be