ytic uremic syndrome (TTP/HUS), have been reported in patients who received Kyprolis. Some of these events have been fatal. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop Kyprolis and eva luate. If the diagnosis of TTP/HUS is excluded, Kyprolis may be restarted. The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.
5.13 Posterior Reversible Encephalopathy Syndrome
Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis. PRES, formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is a neurological disorder which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging (MRI). Discontinue Kyprolis if PRES is suspected and eva luate. The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.
5.14 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.
Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis. Males of reproductive potential should be advised to avoid fathering a child while being treated with Kyprolis. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1, 8.3)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Cardiac Toxicities [see Warnings and Precautions (5.1)]
Acute Renal Failure [see Warnings and Precautions (5.2)]
Tumor Lysis Syndrome [see Warnings and Precautions (5.3)]
Pulmonary Toxicity [see Warnings and Precautions (5.4)]
Pulmonary Hypertension [see Warnings and Precautions (5.5)]
Dyspnea [see Warnings and Precautions (5.6)]
Hypertension [see Warnings and Precautions (5.7)]
Venous Thrombosis [see Warnings and Precautions (5.8)]
Infusion Reactions [see Warnings and Precautions (5.9)]
Thrombocytopenia [see Warnings and Precautions (5.10)]
Hepatic Toxicity and Hepatic Failure [see Warnings and Precautions (5.11)]
Thrombotic Microangiopathy [see Warnings and Precautions (5.12)]
Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.13)]
6.1 Clinical Trials 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 in medical practice.
Safety Experience with Kyprolis in Combination with Lenalidomide and Dexamethasone in Patients with Multiple Myeloma
The safety of Kyprolis in combination with lenalidomide and dexamethasone (KRd) was eva luated in an open-label randomized study in patients with relapsed multiple myeloma. Details of the study treatment are described in Section 14.1. The median number of cycles initiated was 22 cycles for the KRd arm and 14 cycles for the Rd arm.
Deaths due to adverse reactions within 30 days of the last dose of any t |
