reported on other days throughout the cycle. The median time to resolution of HUS was 11.5days (range: 2 to 44). All cases resolved, including those who discontinued LUMOXITI.
Avoid LUMOXITI in patients with prior history of severe thrombotic microangiopathy (TMA) or HUS.
Administer prophylactic intravenous fluids before and after LUMOXITI infusions [see Dosage andAdministration (2.2)].
In Study 1053, patients with a platelet count ≥ 100,000/mm3 received low-doseaspirin on Days 1 through 8 of each 28-day cycle for prophylaxis of thrombosis.
Monitor blood chemistry and complete blood counts prior to each dose and on Day 8 of each treatmentcycle.
Monitoring mid-cycle is also recommended. Consider the diagnosis of HUS in patients whodevelop hemolytic anemia, worsening or sudden onset of thrombocytopenia, increase in creatinine levels,elevation of bilirubin and/or LDH, and have evidence of hemolysis based on peripheral blood smearschistocytes [see Dosage and Administration (2.3)].
The events of HUS may be life-threatening if treatment is delayed with increased risk of progressive renalfailure requiring dialysis. If HUS is suspected initiate appropriate supportive measures, including fluidrepletion, hemodynamic monitoring, and consider hospitalization as clinically indicated. DiscontinueLUMOXITI in patients with HUS [see Dosage and Administration (2.3)].
5.3 Renal Toxicity
Renal toxicity has been reported in patients treated with LUMOXITI therapy. In the combined safetydatabase of HCL patients treated with LUMOXITI, 26% (34/129) reported adverse events of renaltoxicity, including acute kidney injury (2.3%), renal failure (2.3%), renal impairment (1.6%), serumcreatinine increased (17%), and proteinuria (8%). Grade 3 acute kidney injury occurred in 1.6% (2/129)of patients. All other events were mild to moderate in severity.
Based on laboratory findings, during treatment, serum creatinine increased by two or more grades frombaseline in 22% (29/129) of patients, including increases of Grade 3 in 1.6% (2/129) of patients.
At theend of treatment, serum creatinine levels remained elevated at 1.5- to 3-times the upper limit of normal in5% of patients. Patients who experience HUS, those ≥ 65 years of age, or those with baseline renalimpairment may be at increased risk for worsening of renal function following treatment withLUMOXITI [see Use in Specific Populations (8.5)].
Monitor renal function prior to each infusion of LUMOXITI, and as clinically indicated throughouttreatment. Delay LUMOXITI dosing in patients with Grade ≥ 3 elevations in creatinine, or uponworsening from baseline by ≥ 2 grades [see Dosage and Administration (2.3)].
5.4 Infusion Related Reactions
Infusion related reactions occurred in patients treated with LUMOXITI, and were defined as theoccurrence of any one of the following events on the day of study drug infusion: chills, cough, dizziness,dyspnea, feeling hot, flushing, headache, hypertension, hypotension, infusion related reaction, myalgianausea, pyrexia, sinus tachycardia, tachycardia, vomiting, or wheezing. In Study 1053, infusion relatedreactions occurred in 50% (40/80) of patients. Grade 3 infusion related events as defined, occurred in 11%(9/80) of LUMOXITI-treated patients. The most frequently reported infusion related events were nausea(15%), pyrexia (14%), chills (14%), vomiting (11%), headache (9%), and infusion related reaction (9%).
Infusion r |
