DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Capillary Leak Syndrome (CLS)
5.2 Hemolytic Uremic Syndrome (HUS)
5.3 Renal Toxicity
5.4 Infusion Related Reactions
5.5 Electrolyte Abnormalities
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
WARNING: CAPILLARY LEAK SYNDROME and HEMOLYTIC UREMIC SYNDROME
Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patientsreceiving LUMOXITI. Monitor weight and blood pressure; check labs, including albumin,if CLS is suspected. Delay dosing or discontinue LUMOXITI as recommended [see Dosageand Administration (2.3) and Warnings and Precautions (5.1)].
Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patientsreceiving LUMOXITI. Monitor hemoglobin, platelet count, serum creatinine, and ensureadequate hydration. Discontinue LUMOXITI in patients with HUS [see Dosage andAdministration (2.3) and Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
LUMOXITI is 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 nucleosideanalog (PNA).
Limitations of Use
LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min) [seeDosage and Administration (2.3), Warnings and Precautions (5.3), and Use in Specific Populations(8.5)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of LUMOXITI is 0.04 mg/kg administered as a 30-minute intravenous infusionon Days 1, 3, and 5 of each 28-day cycle. Continue LUMOXITI treatment for a maximum of 6 cycles,disease progression, or unacceptable toxicity.
2.2 Recommended Concomitant Treatment
Hydration
Intravenously administer 1 L of isotonic solution (e.g., 5% Dextrose Injection, USP and 0.45% or 0.9%Sodium Chloride Injection, USP) over 2-4 hours before and after each LUMOXITI infusion. Administer0.5 L to patients under 50 kg.
Advise all patients to adequately hydrate with up to 3 L (twelve 8-oz glasses) of oral fluids (e.g., water,milk, or juice) per 24 hours on Days 1 through 8 of each 28-day cycle. In patients under 50 kg, up to 2 L(eight 8-oz glasses) per 24 hours is recommended.
Monitor fluid balance and serum electrolytes to avoid fluid overload and/or electrolyte abnormalities [seeWarnings and Precautions (5.2, 5.5)].
Thromboprophylaxis
Consider low-dose aspirin on Days 1 through 8 of each 28-day cycle.
Monitor for signs and symptoms of thrombosis [see Warnings and Precautions (5.2)].
Premedication
Premedicate 30-90 minutes prior to each LUMOXITI infusion with:
An antihistamine ( |
