Lumoxiti Generic Name & Formulations
Moxetumomab pasudotox-tdfk 1mg; per vial; lyophilized cake or pwd for IV infusion after reconstitution and dilution; preservative-free.
Relapsed or refractory hairy cell leukemia (HCL) in adults who received ≥2 prior systemic therapies, including a purine nucleoside analog (PNA).
Limitations of Use
Not recommended in severe renal impairment (CrCl ≤29mL/min).
Lumoxiti Dosage and Administration
Premedicate with an antihistamine, APAP, and H2-receptor antagonist 30–90mins prior to each infusion. Give IV isontonic soln over 2–4hrs before and after each infusion. Consider low-dose aspirin on Days 1–8 of each cycle as thromboprophylaxis. Give as IV infusion over 30mins. 0.04mg/kg on Days 1, 3, and 5 of each 28-day cycle for max 6 cycles, until disease progression or unacceptable toxicity. Post-infusion: consider oral antihistamines, antipyretics, and an oral corticosteroid (see full labeling).
Lumoxiti Boxed Warnings
Capillary leak syndrome. Hemolytic uremic syndrome.
Risk of capillary leak syndrome (CLS) and hemolytic uremic syndrome (HUS). Monitor weight and BP prior to and during treatment. Withhold if Grade 2 CLS until resolution; permanently discontinue if Grade ≥3. History of severe thrombotic microangiopathy or HUS; avoid. Monitor CBCs, serum electrolytes prior to each dose, on Day 8, and mid-cycle of each treatment. Monitor for thrombosis and fluid balance. Initiate supportive measures if HUS is suspected (including fluid repletion, hemodynamic monitoring, possible hospitalization); discontinue if develops. Maintain adequate hydration per cycle (see full labeling). Monitor renal function; delay dosing if Grade ≥3 creatinine elevation or upon worsening from baseline ≥2 grades. Monitor for severe infusion-related reactions; interrupt infusion and treat appropriately if occurs. Renal impairment. Elderly. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after last dose. Nursing mothers.
Lumoxiti Adverse Reactions
Infusion related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, diarrhea, creatinine increased, ALT/AST increased, hypoalbuminemia, hypocalcemia, hypophosphatemia; CLS, HUS, renal toxicity.
Lumoxiti Clinical Trials
Lumoxiti Patient Counseling