elated reactions may occur during any cycle of treatment with LUMOXITI. Prior to each doseof LUMOXITI, premedicate with antihistamines and antipyretics. If a severe infusion related reactionoccurs, interrupt the LUMOXITI infusion and institute appropriate medical management. Administer anoral or intravenous corticosteroid approximately 30 minutes before resuming, or before the nextLUMOXITI infusion [see Dosage and Administration (2.2)].
5.5 Electrolyte Abnormalities
In the combined safety database of HCL patients treated with LUMOXITI, electrolyte abnormalitiesoccurred in 57% (73/129) of patients with the most common electrolyte abnormality being hypocalcemiaoccurring in 25% of patients.
Grade 3 electrolyte abnormalities occurred in 14% (18/129) of patients andGrade 4 electrolyte abnormalities occurred in 0.8% (1/129) of patients. Electrolyteabnormalities cooccurredin the same treatment cycle with CLS, HUS, fluid retention, or renal toxicity in 37% (48/129) ofpatients.
Monitor serum electrolytes prior to each dose and on Day 8 of each treatment cycle. Monitoring midcycleis also recommended.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling.
Capillary Leak Syndrome [see Warnings and Precautions (5.1)]
Hemolytic Uremic Syndrome [see Warnings and Precautions (5.2)]
Renal Toxicity [see Warnings and Precautions (5.3)]
Infusion Related Reactions [see Warnings and Precautions (5.4)]
Electrolyte Abnormalities [see Warnings and Precautions (5.5)]
6.1 Clinical Trials Experience
As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and maynot reflect the rates observed in practice.
The safety data described in this section reflect exposure to LUMOXITI in 80 patients with previouslytreated HCL in Study 1053 [see Clinical Studies (14)]. Patients received LUMOXITI 0.04 mg/kg as anintravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle for a maximum of 6 cyclesor until disease progression or unacceptable toxicity.
The median duration of treatment with LUMOXITI was 5.7 months (range: 0.9 to 6.7), with a median of6 treatment cycles started in each patient.
The most common non-laboratory adverse reactions (≥ 20%) of any grade were infusion related reactions,edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea. The most common Grade 3or 4 adverse reactions (reported in at least ≥ 5% of patients) were hypertension, febrile neutropenia, andHUS.
The most common laboratory abnormalities (≥ 20%) of any grade were creatinine increased, ALTincreased, hypoalbuminemia, AST increased, hypocalcemia, hypophosphatemia, hemoglobin decreased,neutrophil count decreased, hyponatremia, blood bilirubin increased, hypokalemia, GGT increased,hypomagnesemia, platelet count decreased, hyperuricemia, and alkaline phosphate increased.
Adverse reactions resulting in permanent discontinuation of LUMOXITI occurred in 15% (12/80) ofpatients.
The most common adverse reactionleadingtoLUMOXITIdiscontinuation was HUS (5%).
Themost common adverse reaction resulting in dose delays, omissions, or interruptions was pyrexi |
