HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useLUMOXITI safely and effectively. See full prescribing information forLUMOXITI.
LUMOXITI™(moxetumomab pasudotox-tdfk)for injection, forintravenous use
Initial U.S. Approval: 2018
WARNING: CAPILLARY LEAK SYNDROME and
 
HEMOLYTIC UREMIC SYNDROME
 
See full prescribing information for complete boxed warning.
Capillary Leak Syndrome (CLS), including life-threateningcases, occurred in patients receiving LUMOXITI. Delay dosingor discontinue LUMOXITI as recommended. (2.3, 5.1)
Hemolytic Uremic Syndrome (HUS), including life-threateningcases, occurred in patients receiving LUMOXITI.
Discontinue LUMOXITI in patients with HUS. (2.3, 5.2)
INDICATIONS AND USAGE
LUMOXITI is a CD22-directed cytotoxin indicated for the treatment of adultpatients with relapsed or refractory hairy cell leukemia (HCL) who received atleast two prior systemic therapies, including treatment with a purinenucleoside analog (PNA). (1)
Limitations of Use
Not recommended in patients with severe renal impairment (CrCl ≤ 29mL/min). (1)
DOSAGE AND ADMINISTRATION
Recommended dosage: 0.04 mg/kg as an intravenous infusion over 30minutes on Days 1, 3, and 5 of each 28-day cycle. (2.1)
Maintain adequate hydration throughout treatment. (2.2)
Consider low-dose aspirin on Days 1 to 8 of each 28-day cycle. (2.2)
Premedicate with an acetaminophen antipyretic, antihistamine, and H2-receptor antagonist prior to all infusions. (2.2)
See full prescribing information for instructions on reconstitution oflyophilized cake or powder, and preparation and administration ofreconstituted drug. (2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 1 mg lyophilized cake or powder in a single-dose vial forreconstitution and further dilution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Renal Toxicity: Monitor for changes in renal function prior to eachinfusion and as clinically indicated. Delay dosing until recovery. (5.3)
Infusion Related Reactions: Pre-medicate and if a severe infusionrelated reaction occurs, interrupt the LUMOXITI infusion and instituteappropriate medical management. (5.4)
Electrolyte Abnormalities: Monitor serum electrolytes prior to each doseand on Day 8 of each treatment cycle. Monitoring mid-cycle is alsorecommended. (5.5)
ADVERSE REACTIONS
Most common (≥ 20%) adverse reactions are infusion related reactions,edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea.
Most common (≥ 50%) laboratory abnormalities are creatinine increased,ALT increased, hypoalbuminemia, AST increased, hypocalcemia, andhypophosphatemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZenecaat 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide.
Revised: 9/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CAPILLARY LEAK SYNDROME AND HEMOLYTIC
UREMIC SYNDROME
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Recommended Concomitant Treatment
2.3 Monitoring to Assess Safety
2.4 Instructions for Reconstitution, Dilution, and Administration
3