For: Hairy Cell Leukemia
Lumoxiti (moxetumomab pasudotox-tdfk) is an anti-CD22 recombinant immunotoxin for the treatment of adult patients with hairy cell leukemia.LUMOXITI (moxetumomab pasudotox-tdfk) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized cake or powder in a 1 mg single-dose vial. Each carton (NDC 0310-4700-01) contains one single-dose vial.
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IV Solution Stabilizer is supplied as a sterile, preservative-free, colorless to slightly yellow, clear solution free from visible particles in a 1 mL single-dose vial. The IV Solution Stabilizer is packaged separately from LUMOXITI. Each carton (NDC 0310-4715-11) contains one single-dose vial. Do not use the IV Solution Stabilizer to reconstitute LUMOXITI.
Only one vial of IV Solution Stabilizer should be used per administration of LUMOXITI.
Storage and Handling
Refrigerate LUMOXITI and IV Solution Stabilizer at 2�C to 8�C (36�F to 46�F), in original carton to protect from light. Do not freeze. Do not shake. These highlights do not include all the information needed to use LUMOXITI safely and effectively. See full prescribing information for LUMOXITI.
LUMOXITI� (moxetumomab pasudotox-tdfk) for injection, for intravenous use
Initial U.S. Approval: 2018
WARNING: CAPILLARY LEAK SYNDROME and HEMOLYTIC UREMIC SYNDROME
See full prescribing information for complete boxed warning.
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Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving LUMOXITI. Delay dosing or discontinue LUMOXITI as recommended. (2.3, 5.1)
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Hemolytic Uremic Syndrome (HUS), including life-threatening cases, 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 adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). (1)
Limitations of Use
Not recommended in patients with severe renal impairment (CrCl ? 29 mL/min). (1)
DOSAGE AND ADMINISTRATION
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Recommended dosage: 0.04 mg/kg as an intravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle. (2.1)
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Maintain adequate hydration throughout treatment. (2.2)
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Consider low-dose aspirin on Days 1 to 8 of each 28-day cycle. (2.2)
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Premedicate with an acetaminophen antipyretic, antihistamine, and H2-receptor antagonist prior to all infusions. (2.2)
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See full prescribing information for instructions on reconstitution of lyophilized cake or powder, and preparation and administration of reconstituted drug. (2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 1 mg lyophilized cake or powder in a single-dose vial for reconstitution and further dilution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Renal Toxicity: Monitor for changes in renal function prior to each infusion and as clinically indicated. Delay dosing until recovery. (5.3)
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Infusion Related Reactions: Pre-medicate and if a severe infusion related reaction occurs, interrupt the LUMOXITI infusion and institute appropriate medical management. (5.4)
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Electrolyte Abnormalities: Monitor serum electrolytes prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended. (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, and hypophosphatemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 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 Medication Guide.
Revised: 1/2019
