B:16.75”
T:16.25”
S:14.625”
KYPROLIS® (carfilzomib) for injection, for intravenous use Brief Summary of
Prescribing Information.
Please see the KYPROLIS package insert for full prescribing information.
INDICATIONS
Kyprolis in combination with lenalidomide and dexamethasone is indicated for the
treatment of patients with relapsed multiple myeloma who have received one to three
prior lines of therapy.
WARNINGS AND PRECAUTIONS
Cardiac Toxicities
New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure,
pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial
ischemia, and myocardial infarction including fatalities within a day in patients receiving
Kyprolis. Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until recovery,
and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk
assessment. Adequately hydrate all patients prior to receiving Kyprolis.
Monitor all patients for evidence of volume overload, especially patients at risk for cardiac
failure. Adjust total fluid intake as clinically appropriate. Patients ≥ 75 years, with New
York Heart Association Class III and IV heart failure, recent myocardial infarction, and
conduction abnormalities may be at greater risk for cardiac complications.
Acute Renal Failure
Cases of acute renal failure have occurred in patients receiving Kyprolis. Renal
insufficiency adverse events (renal impairment, acute renal failure, renal failure) occurred
in approximately 8% patients in a randomized controlled trial. Acute renal failure was
reported more frequently in patients with advanced relapsed and refractory multiple
myeloma who received Kyprolis monotherapy. This risk was greater in patients with
a baseline reduced estimated creatinine clearance. Monitor renal function with regular
measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or
withhold Kyprolis dose as approp &