have been reported (< 1%). KYPROLIS can cause elevations of serum transaminases and bilirubin.
Withhold KYPROLIS in patients experiencing Grade 3 or greater elevations of transaminases, bilirubin, or
other liver abnormalities until resolved or returned to baseline. After resolution, consider if restarting
KYPROLIS is appropriate. Monitor liver enzymes frequently [see Dosage and Administration and Adverse
Reactions]. Embryo-fetal Toxicity. KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in animals. There are no adequate and well‑controlled
studies in pregnant women using KYPROLIS. Carfilzomib caused embryo‑fetal toxicity in pregnant rabbits at
doses that were lower than in patients receiving the recommended dose. Females of reproductive potential
should be advised to avoid becoming pregnant while being treated with KYPROLIS. If this drug is used during
pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the
potential hazard to the fetus [see Use in Specific Populations].
ADVERSE REACTIONS: The following adverse reactions are discussed in greater detail in other sections
of the labeling:
• Cardiac Arrest, Congestive Heart Failure, Myocardial Ischemia [see
Warnings and Precautions]
• Pulmonary Hypertension [see
Warnings and Precautions]
• Pulmonary Complications [see
Warnings and Precautions]
• Infusion Reactions [see
Warnings and Precautions]
• Tumor Lysis Syndrome [see
Warnings and Precautions]
• Thrombocytopenia [see
Warnings and Precautions]
• Hepatic Toxicity and Hepatic Failure [see
Warnings and Precautions]
The most common adverse reactions (incidence of 30% or greater) to KYPROLIS observed in clinical trials
of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea,
and pyrexia. Clinical Trials Safety Experience. Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly
compared with rates in the clinical trials of another drug, and may not reflect the rates observed i