ASH Clinical News July 2015_updated | 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 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.
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 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
Onyx, Onyx Pharmaceuticals,
Onyx Pharmaceuticals logo, Kyprolis,
and Kyprolis logo are all trademarks
of Onyx Pharmaceuticals, Inc.
©2015 Onyx Pharmaceuticals, Inc.,
South San Francisco, CA
TROPIC-KYPR-100826J(1) May 2015
Printed in USA
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 considered
to be at greater risk for TLS. Prior to receiving KYPROLIS, ensure
that patients are well hydrated. Monitor for evidence of TLS during
treatment, and manage promptly. Interrupt KYPROLIS until TLS
is resolved.
Thrombocytopenia: KYPROLIS causes thrombocytopenia with platelet
nadirs occurring around Day 8 of each 28-day cycle and recovery to
baseline by the start of the next 28-day cycle. In patients with multiple
myeloma, 36% of patients experienced thrombocytopenia, including
Grade 4 in 10%. Thrombocytopenia following KYPROLIS administration