LUMOXITI must be reconstituted and diluted by a health care provider using aseptic technique. Refer to the Healthcare Provider Instructions for Use for LUMOXITI for full reconstitution, dilution, and administration information.1
Reconstitute LUMOXITI vials with Sterile Water for Injection, USP only.
Add the IV Solution Stabilizer to the infusion bag prior to adding LUMOXITI solution to the infusion bag. Vial of IV Solution Stabilizer is packaged separately.
For intravenous infusion only.
Intravenously administer 1 L of isotonic solution (eg, 5% Dextrose Injection, USP and 0.45% or 0.9% Sodium Chloride Injection, USP) over 2-4 hours before and after each LUMOXITI infusion. Administer 0.5 L to patients under 50 kg.1
Advise all patients to adequately hydrate with up to 3 L (twelve 8-oz glasses) of oral fluids (eg, 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.1
Monitor fluid balance and serum electrolytes to avoid fluid overload and/or electrolyte abnormalities. [see Warnings and Precautions].
Consider low-dose aspirin on Days 1 through 8 of each 28-day cycle.1
Monitor for signs and symptoms of thrombosis.1 [see Warnings and Precautions].
Premedicate 30-90 minutes prior to each LUMOXITI infusion with1:
If a severe infusion related reaction occurs, interrupt the LUMOXITI infusion and institute appropriate medical management. Administer an oral or intravenous corticosteroid approximately 30 minutes before resuming and before each LUMOXITI infusion thereafter.1 [see Warnings and Precautions].
Manage adverse reactions by withholding and/or discontinuing LUMOXITI as described below.1
Identify Capillary Leak Syndrome (CLS) and Hemolytic Uremic Syndrome (HUS) based on clinical presentation (see Table).1
Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Patients who experience Grade 2 or higher CLS should receive appropriate supportive measures, including treatment with oral or intravenous corticosteroids, with monitoring of weight, albumin levels, and blood pressure until resolution.1
Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Discontinue LUMOXITI in patients with HUS. Treat with appropriate supportive measures and fluid replacement, with monitoring of blood chemistry, complete blood counts, and renal function until resolution.1
For patients with baseline serum creatinine within normal limits, delay dosing for Grade 2 or higher creatinine increases (greater than 1.5-times baseline or the upper limit of normal). Resume LUMOXITI upon recovery to Grade 1 (1- to 1.5-times baseline, or between the upper limit of normal and 1.5-times the upper limit of normal).1
For patients with baseline serum creatinine of Grades 1 or 2, delay dosing for creatinine increases to Grade 3 or higher (greater than 3-times baseline or the upper limit of normal). Resume LUMOXITI upon recovery to baseline grade or lower.1
Most cases of CLS occurred in the first 8 days (range: 1 to 19) of a treatment cycle, however, cases have also been reported on other days throughout the cycle. The median time to resolution of CLS was 12 days (range: 1 to 53).
Monitor patient weight and blood pressure prior to each LUMOXITI infusion and as clinically indicated during treatment. Assess patients for signs and symptoms of CLS, including weight gain (increase in 5.5 pounds (2.5 kg) or ≥ 5% from Day 1 of current cycle), hypotension, peripheral edema, shortness of breath or cough, and pulmonary edema and/or serosal effusions. In addition, the following changes in laboratory parameters may help identify CLS: hypoalbuminemia, elevated hematocrit, leukocytosis, and thrombocytosis.
CLS may be life-threatening or fatal if treatment is delayed. Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time. Patients who develop CLS should receive appropriate supportive measures, including concomitant oral or intravenous corticosteroids, and hospitalization as clinically indicated. Withhold LUMOXITI for Grade 2 CLS until resolution, and permanently discontinue for Grade ≥ 3 CLS.
Most cases of HUS occurred in the first 9 days (range: 1 to 16) of a treatment cycle, however, cases have also been reported on other days throughout the cycle. The median time to resolution of HUS was 11.5 days (range: 2 to 44). All cases resolved, including those who discontinued LUMOXITI.
Avoid LUMOXITI in patients with prior history of severe thrombotic microangiopathy (TMA) or HUS. Administer prophylactic intravenous fluids before and after LUMOXITI infusions. In Study 1053, patients with a platelet count ≥ 100,000/mm3 received low-dose aspirin on Days 1 through 8 of each 28-day cycle for prophylaxis of thrombosis.
Monitor blood chemistry and complete blood counts prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended. Consider the diagnosis of HUS in patients who develop hemolytic anemia, worsening or sudden onset of thrombocytopenia, increase in creatinine levels, elevation of bilirubin and/or LDH, and have evidence of hemolysis based on peripheral blood smear schistocytes.
The events of HUS may be life-threatening if treatment is delayed with increased risk of progressive renal failure requiring dialysis. If HUS is suspected initiate appropriate supportive measures, including fluid repletion, hemodynamic monitoring, and consider hospitalization as clinically indicated. Discontinue LUMOXITI in patients with HUS.
Based on laboratory findings, during treatment, serum creatinine increased by two or more grades from baseline in 22% (29/129) of patients, including increases of Grade 3 in 1.6% (2/129) of patients. At the end of treatment, serum creatinine levels remained elevated at 1.5- to 3-times the upper limit of normal in 5% of patients. Patients who experience HUS, those ≥ 65 years of age, or those with baseline renal impairment may be at increased risk for worsening of renal function following treatment with LUMOXITI.
Monitor renal function prior to each infusion of LUMOXITI, and as clinically indicated throughout treatment. Delay LUMOXITI dosing in patients with Grade ≥ 3 elevations in creatinine, or upon worsening from baseline by ≥ 2 grades.
Infusion related reactions may occur during any cycle of treatment with LUMOXITI. Premedicate with antihistamines and antipyretics prior to each LUMOXITI dose. If a severe infusion related reaction occurs, interrupt the LUMOXITI infusion and institute appropriate medical management. Administer an oral or intravenous corticosteroid approximately 30 minutes before resuming, or before the next LUMOXITI infusion.
Monitor serum electrolytes prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended.
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