ASH News Daily 2013 - Day 2 - (Page B-24)
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 last therapy. Approval is based on response rate.
Clinical benefit, such as improvement in survival or symptoms, has not been verified.
THE POWER OF
SECOND-GENERATION
PROTEASOME INHIBITION
TAKES FLIGHT
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 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.
Table of Contents for the Digital Edition of ASH News Daily 2013 - Day 2
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ASH News Daily 2013 - Day 2
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