ADVERSE REACTIONS ASSOCIATED WITH LUMOXITI
Study 1053: Adverse Reactionsa in ≥20% (All Grades) of Patients with HCL (N=80)1
aPer National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
bInfusion-related reactions: include patients who were reported to have one or more infusion event that may be infusion-related on the day of study drug infusion.
Adverse Reactions: Clinical Trials Experience
Fluid retention occurred in 63% (50/80) of patients treated with LUMOXITI in Study 1053, including Grade 3 in 1.3% (1/80) of patients. Fluid retention included all preferred terms of edema peripheral (39%), face edema (14%), abdominal distension (13%), weight increased (8%), pleural effusion (6%), edema (5%), peripheral swelling (5%), localized edema (3.8%), ascites (1.3%), fluid overload (1.3%), fluid retention (1.3%), and pericardial effusion (1.3%). Of the fifty patients with fluid retention, 29% of patients required diuretics.
Ocular adverse events occurred, including: blurred vision (9%), dry eye (8%), cataracts (5%), ocular discomfort and/or pain (4%), ocular swelling/periorbital edema (4%), conjunctivitis (1.3%), conjunctival hemorrhage (1.3%), and ocular discharge (1.3%).1
Study 1053: Laboratory Abnormalitiesc in ≥20% (All Grades) Reported in Patients with HCL (N=80)1
ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma glutamyl transferase.
cPer National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and based on laboratory measurements worsening from baseline.
15% of patients in Study 1053 discontinued due to drug-related adverse reactions1
- The most common adverse reaction leading to LUMOXITI discontinuation was hemolytic uremic syndrome (HUS) (5%)1
- The most common adverse reaction resulting in dose delays, omissions, or interruptions was pyrexia (3.8%)1