Kyprolis® (carfilzomib) for Injection Now Has a Permanent J Code: J9047
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.