Medically reviewed by Drugs.com. Last updated on Sep 3, 2020.
Generic name: MOXETUMOMAB PASUDOTOX 1mg in 1mL
Dosage form: injection, powder, lyophilized, for solution
The recommended dose of LUMOXITI is 0.04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Continue LUMOXITI treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity.
Recommended Concomitant Treatment
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. Administer 0.5 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.
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)].
Premedicate 30-90 minutes prior to each LUMOXITI infusion with:
- An antihistamine (e.g., hydroxyzine or diphenhydramine)
- Acetaminophen antipyretic
- A histamine-2 receptor antagonist (e.g., ranitidine, famotidine, or cimetidine)
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 [see Warnings and Precautions (5.4)].
Monitoring to Assess Safety
Manage adverse reactions by withholding and/or discontinuing LUMOXITI as described below.
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.|
|Monitoring Parameter||Before every infusion, check:
||Before every infusion, check:
||If HUS is suspected, promptly check blood LDH, indirect bilirubin, and blood smear schistocytes for evidence of hemolysis.|
Capillary Leak Syndrome (CLS)
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 [see Warnings and Precautions (5.1)].
|CLS Grade||LUMOXITI Dosing|
|Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|
Symptomatic; medical intervention indicated
|Delay dosing until recovery of symptoms.|
Severe symptoms; medical intervention indicated
Life-threatening consequences; urgent intervention indicated
Hemolytic Uremic Syndrome (HUS)
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 [see Warnings and Precautions (5.2)].
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).
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 [see Warnings and Precautions (5.3)].
Instructions for Reconstitution, Dilution, and Administration
LUMOXITI must be reconstituted and diluted by a healthcare provider using aseptic technique. Refer to the Healthcare Provider Instructions for Use for LUMOXITI for full reconstitution, dilution, and administration information.
Step 1: Calculate Dose
- Calculate the dose (mg) and the number of LUMOXITI vials (1 mg/vial) to be reconstituted. The final concentration of the reconstituted LUMOXITI solution is 1 mg/mL.
- DO NOT round down for partial vials.
- Individualize dosing based on the patient's actual body weight prior to the first dose of the first treatment cycle.
- A change in dose should only be made between cycles when a change in weight of greater than 10% is observed from the weight used to calculate the first dose of the first treatment cycle. No change in dose should be made during a particular cycle.
Step 2: Reconstitution
Reconstitute LUMOXITI vials with Sterile Water for Injection, USP only.
- Reconstitute each LUMOXITI (1 mg/vial) with 1.1 mL Sterile Water for Injection, USP. The resulting 1 mg/mL solution allows a withdrawal volume of 1 mL.
- Direct the Sterile Water for Injection, USP along the walls of the vial and not directly at the lyophilized cake or powder.
- DO NOT reconstitute LUMOXITI vials with the IV Solution Stabilizer.
- Gently swirl the vial until completely dissolved. Invert the vial to ensure all cake or powder in the vial is dissolved. Do not shake.
- Visually inspect that the reconstituted solution is clear to slightly opalescent, colorless to slightly yellow, and free from visible particles. Do not use if solution is cloudy, discolored, or contains any particles.
- Use reconstituted solution immediately. Do not store reconstituted LUMOXITI vials. See Table 3 for storage times and conditions for the reconstituted solution.
Step 3: Dilution
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.
- Obtain a 50 mL 0.9% Sodium Chloride Injection, USP infusion bag.
- Add 1 mL IV Solution Stabilizer to the infusion bag containing 50 mL 0.9% Sodium Chloride Injection, USP.
- Only one vial of IV Solution Stabilizer should be used per administration of LUMOXITI.
- Gently invert the bag to mix the solution. Do not shake.
- Withdraw the required volume (calculated from Step 1) of LUMOXITI solution from the reconstituted vial(s).
- Inject LUMOXITI into the infusion bag containing 50 mL 0.9% Sodium Chloride Injection, USP and 1 mL IV Solution Stabilizer.
- Gently invert the bag to mix the solution. Do not shake.
- Discard any partially used or empty vials of LUMOXITI and IV Solution Stabilizer.
- See Table 3 for storage times and conditions for the diluted solution.
Step 4: Administration Instructions
For intravenous infusion only.
- Administer the diluted solution intravenously over 30 minutes.
- Do not mix LUMOXITI, or administer as an infusion with other medicinal products.
- After the infusion, flush the intravenous administration line with of 0.9% Sodium Chloride Injection, USP at the same rate as the infusion. This ensures that the full LUMOXITI dose is delivered.
|Reconstituted Solution||Diluted LUMOXITI Solution in Infusion Bag|
|LUMOXITI does not contain bacteriostatic preservatives. Use reconstituted solution immediately.
DO NOT STORE reconstituted LUMOXITI vials.
|Use diluted solution immediately or after storage at room temperature (20°C to 25°C; 68°F to 77°F) for up to 4 hours or store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
PROTECT FROM LIGHT.
DO NOT FREEZE.
DO NOT SHAKE.
|If the diluted solution is refrigerated (2°C to 8°C; 36°F to 46°F), allow it to equilibrate at room temperature (20°C to 25°C; 68°F to 77°F) for no more than 4 hours prior to administration.
Administer diluted solution within 24 hours of reconstitution as a 30-minute infusion.
PROTECT FROM LIGHT.
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