e.g., hydroxyzine or diphenhydramine)
Acetaminophen antipyretic
A histamine-2 receptor antagonist (e.g., ranitidine, famotidine, or cimetidine)
If a severe infusion related reaction occurs, interrupt the LUMOXITI infusion and institute appropriatemedical management. Administer an oral or intravenous corticosteroid approximately 30 minutes beforeresuming, and before each LUMOXITI infusion thereafter [see Warnings and Precautions (5.4)].
Post-infusion Medication
Consider oral antihistamines and antipyretics for up to 24 hours following LUMOXITI infusions.
An oral corticosteroid (e.g., 4 mg dexamethasone) is recommended to decrease nausea and vomiting.
Maintain adequate oral fluid intake.
2.3 Monitoring to Assess Safety
Manage adverse reactions by withholding and/or discontinuing LUMOXITI as described below.
Identify Capillary Leak Syndrome (CLS) and Hemolytic Uremic Syndrome (HUS) based on clinicalpresentation (see Table 1).
Table 1: Monitoring for CLS and HUS
CLS HUS
Monitoring
Parameter
Before every infusion, check:
Weight
Blood pressure
Before every infusion, check:
Hemoglobin levels
Platelet count
Serum creatinine
Assessment
If weight has increased by 5.5
pounds (2.5 kg) or 5% or greaterfrom Day 1 of the cycle and the
patient is hypotensive, promptlycheck for peripheral edema,hypoalbuminemia, andrespiratory symptoms, includingshortness of breath and cough.
If CLS is suspected, check for adecrease in oxygen saturation
If HUS is suspected, promptly check bloodLDH, indirect bilirubin, and blood smearschistocytes for evidence of hemolysis.
CLS HUS
and evidence of pulmonary
edema and/or serosal effusions.
Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)version 4.03.
Capillary Leak Syndrome (CLS)
Patients who experience Grade 2 or higher CLS should receive appropriate supportive measures,including treatment with oral or intravenous corticosteroids, with monitoring of weight, albumin levels,and blood pressure until resolution [see Warnings and Precautions (5.1)].
Table 2: CLS Grading and Management Guidance
CLS Grade LUMOXITI Dosing
Grade 2
Symptomatic; medical intervention indicated Delay dosing until recovery of symptoms.
Grade 3
Severe symptoms; medical intervention indicated
Grade 4 Discontinue LUMOXITI.
Life-threatening consequences; urgent intervention
indicated
Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Hemolytic Uremic Syndrome (HUS)
Discontinue LUMOXITI in patients with HUS. Treat with appropriate supportive measures and fluidreplacement, with monitoring of blood chemistry, complete blood counts, and renal function untilresolution [see Warnings and Precautions (5.2)].
Increased Creatinine
For patients with baseline serum creatinine within normal limits, delay dosing for Grade 2 or highercreatinine increases (greater than 1.5-times baseline or the upper limit of normal).
Resume LUMOXITIupon recovery to Grade 1 (1- to 1.5-times baseline, or between the upper limit of normal and 1.5-timesthe upper limit of normal).
For patients with baseline serum creatinine of Grades 1 or 2, delay dosing for creatinine increases toGrade 3 or higher (grea |
