Leukemias, lymphomas, and other hematologic cancers:

Indications for LUMOXITI:

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).

Adult:

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).

Children:

Not established.

Boxed Warning:

Capillary leak syndrome. Hemolytic uremic syndrome.

Warnings/Precautions:

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. Females of reproductive potential should use effective contraception during and for ≥30 days after last dose. Nursing mothers.

Pharmacologic Class:

CD22-directed cytotoxin.

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.

Generic Availability:

NO

How Supplied:

Single-dose vial—1