Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 1mg/single-use vial
Hairy Cell Leukemia
Planned permanent discontinuation from U.S. market is August 31, 2023
Indicated for adults with relapsed or refractory hairy cell leukemia (HCL) who have received at least 2 prior systemic therapies, including a purine nucleoside analog
0.04 mg/kg IV on days 1, 3, and 5 of each 28-day cycle; infuse over 30 minutes
Continue for maximum of 6 cycles or until disease progression or unacceptable toxicity occurs
Recommended concomitant treatment
-
Hydration
- Administer 1 L of isotonic solution (eg, D5W plus 0.45% or 0.9% NaCl) IV over 2-4 hr before and after each moxetumomab pasudotox infusion; administer 0.5 L if weight <50 kg
- Additionally, adequately hydrate with up to 3 L of oral fluids (eg, water, milk, juice) per 24 hr on Days 1 through 8 of each 28-day cycle (up to 2 L if weight <50 kg)
- Monitor fluid balance and serum electrolytes to avoid fluid overload and/or electrolyte abnormalities
-
Thromboprophylaxis
- Consider low-dose aspirin on Days 1 through 8 of each 28-day cycle
- Monitor for signs and symptoms of thrombosis
-
Premedication
- Premedicate 30-90 minutes before each moxetumomab pasudotox infusion with an antihistamine (eg, hydroxyzine, diphenhydramine), acetaminophen antipyretic, and an H2-antagonist (eg, ranitidine, famotidine, cimetidine)
-
Postinfusion medication
- Consider oral antihistamines and antipyretics for up to 24 hr after infusion
- An oral corticosteroid (eg, 4 mg dexamethasone) is recommended to decrease nausea and vomiting
- Maintain adequate oral fluid intake
Dosage Modifications
Renal impairment
- CrCl ≤29 mL/min: Not recommended
Serum creatinine
-
Baseline within normal limits
- Grade ≥2 (>1-1.5 baseline or ULN) increases: Delay dosing
- Resume dosing upon recovery to ≤Grade 1
-
Baseline Grades 1 or 2
- Creatinine increases to ≥Grade 3 (>3 x baseline or ULN): Delay dosing
- Resume upon recovery to baseline or ≤Grade 1
Capillary leak syndrome (CLS)
-
Grade 2
- Symptomatic; medical intervention indicated
- Delay dosing until symptoms recovered
-
Grade 3
- Severe symptoms; medical intervention indicated
- Discontinue drug
-
Grade 4
- Life-threatening consequences; urgent intervention indicated
- Discontinue drug
Dosing Considerations
Verify pregnancy status of women of reproductive potential before initiating
Monitor for CLS and hemolytic uremic syndrome (HUS)
CLS monitoring
- Check weight and blood pressure before every infusion
- If weight increased by ≥2.5 kg or 5% from Day 1 of the cycle and the patient is hypotensive, promptly check for peripheral edema, hypoalbuminemia, and respiratory symptoms, including shortness of breath and cough
- If CLS suspected, check for decreased oxygen saturation and evidence of pulmonary edema and/or serosal effusions
- CLS ≥Grade 2: Initiate supportive measures including corticosteroids, weight monitoring, albumin levels, and blood pressure until resolution
HUS monitoring
- Check hemoglobin, platelet count, and serum creatinine before every infusion
- If HUS suspected, promptly check blood LDH, indirect bilirubin, and blood smear schistocytes for evidence of hemolysis
- Discontinue drug with HUS; treat with supportive measures and fluid replacement; monitor blood chemistry, complete blood cell counts, and renal function until resolution
Safety and efficacy not established
Exploratory analyses across this population suggest a higher incidence of adverse reactions leading to drug discontinuation (23% vs 7%) and renal toxicity (40% vs 20%) for patients aged ≥65 yr compared with <65 yr
Adverse Effects
>10% (All Grades)
Creatinine increased (96%)
ALT increased (65%)
Hypoalbuminemia (64%)
AST increased (55%)
Hypocalcemia (54%)
Hypophosphatemia (53%)
Infusion-related reactions (50%)
Hemoglobin decreased (43%)
Neutrophil count decreased (41%)
Hyponatremia (41%)
Peripheral edema (39%)
Nausea (35%)
Capillary leak syndrome (34%)
Fatigue (34%)
Headache (33%)
Pyrexia (31%)
Blood bilirubin increased (30%)
Hypokalemia (25%)
GGT increased (25%)
Hypomagnesemia (23%)
Constipation (23%)
Diarrhea (21%)
Anemia (21%)
Platelet count decreased (21%)
Hyperuricemia (21%)
Alkaline phosphatase increased (20%)
>10% (Grades 3 or 4)
Hemoglobin decreased (15%)
Hypophosphatemia (14%)
Neutrophil count decreased (11-20%)
Platelet count decreased (3.8-11%)
1-10% (All Grades)
Hemolytic uremic syndrome (7%)
1-10% (Grades 3 or 4)
Anemia (10%)
Hyponatremia (8.8%)
Infusion-related reactions (3.8%)
ALT increased (3.8%)
Hemolytic uremic syndrome (0.8-3%)
Nausea (2.5%)
Creatinine increased (2.5%)
Hyperuricemia (2.5%)
Capillary leak syndrome (1.6-2%)
Pyrexia (1.3%)
Hypoalbuminemia (1.3%)
AST increased (1.3%)
Blood bilirubin increased (1.3%)
Hypokalemia (1.3%)
Hypomagnesemia (1.3%)
Warnings
Black Box Warnings
Capillary leak syndrome
- Capillary leak syndrome (CLS), including life-threatening cases, reported
- Monitor weight and blood pressure; check labs, including albumin, if CLS is suspected
- Delay dosing or discontinue as recommended
Hemolytic uremic syndrome
- Hemolytic uremic syndrome (HUS), including life-threatening cases, reported
- Monitor hemoglobin, platelet count, and serum creatinine, and ensure adequate hydration
- Discontinue in patients with HUS
Contraindications
None
Cautions
CLS, including life-threatening cases, reported and is characterized by hypoalbuminemia, hypotension, symptoms of fluid overload, and hemoconcentration (see Black Box Warnings, Dosage Modifications, and Dosing Considerations)
HUS, including life-threatening cases, reported and is characterized by the triad of microangiopathic hemolytic anemia, thrombocytopenia, and progressive renal failure (see Black Box Warnings, Dosage Modifications, and Dosing Considerations)
Renal toxicity has been reported; patients who experience HUS, those aged ≥65 yr, or those with baseline renal impairment may be at increased risk for worsening of renal function following treatment
Infusion-related reactions may occur; symptoms include chills, cough, dizziness, dyspnea, feeling hot, flushing, headache, hypertension, hypotension, infusion-related reaction, myalgia, nausea, pyrexia, sinus tachycardia, tachycardia, vomiting, or wheezing; premediate with antihistamines and antipyretics; interrupt infusion if severe and treat with corticosteroids before resuming dose
Electrolyte abnormalities reported; hypocalcemia is most commonly reported (see Dosing Considerations)
Pregnancy
Pregnancy
There are no available data regarding use in pregnant women
Based on mechanism of action and findings in nonpregnant female animals, moxetumomab pasudotox is expected to cause maternal and embryo-fetal toxicity when administered to pregnant women
Contraception
- Women of reproductive potential should use effective contraception during treatment and for at least 30 days after the last dose
Lactation
No data are available regarding the presence of the drug in human milk or the effects on the breastfed child or milk production
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Anti-CD22 recombinant immunotoxin; after the monoclonal antibody binds to CD22, the molecule is internalized; internalization results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death
Absorption
Peak plasma concentration: 379 ng/mL
AUC: 626 ng·h/mL
Distribution
Vd: 6.5 L
Metabolism
Metabolic pathway unknown; however, other protein therapeutics generally undergo proteolytic degradation into small peptides and amino acids via catabolic pathways
Elimination
Half-life: 1.4 hr
Systemic clearance: 25 L/hr (first dose of first cycle); 4 L/hr (subsequent dosing)
Administration
IV Preparation
Calculate dose
- Calculate dose (mg) and number of vials (1 mg/vial) to be reconstituted
- Final concentration of solution is 1 mg/kg
- Do not round down for partial vials
- Individualize dose based on patient’s actual body weight before first dose of first treatment cycle
- Change dose between cycles if a weight gain >10% observed; do not change dose in the midst of a particular cycle
Reconstitution
- Reconstitute with 1.1 mL of sterile water for injection only; do not use IV solution stabilizer to reconstitute the vial
- Direct the sterile water along the walls of the vial and not directly at the lyophilized cake or powder
- Gently swirl the vial until completely dissolved; invert the vial to ensure all cake or powder is dissolved
- Do not shake
- Visually inspect reconstituted solution; it should appear clear to slightly opalescent, colorless to slightly yellow, and free from visible particles; do not use if cloudy, discolored, or contains any particles
- Use reconstituted solution immediately; do not store reconstituted vials
Dilution
- Add 1 mL of IV solution stabilizer to 50 mL 0.9% NaCl infusion bag before adding the reconstituted solution to the infusion bag; vial of IV solution stabilizer is packaged separately
- Only 1 vial of IV solution stabilizer should be used per administration; gently invert the bag to mix the solution
- Withdraw the calculated dose from the reconstituted vial(s) and add to the 0.9% IV bag that contains the solution stabilize
- Gently invert bag to mix; do not shake
- Discard any partially used or empty vials of drug and IV solution stabilizer
IV Administration
Administer diluted solution IV over 30 minutes
Do not mix or administer with other medicinal products
Flush IV line with 0.9% NaCl after infusion at the same infusion rate to ensure the full dose is delivered
Refrigerated diluted solution
- If the diluted solution is refrigerated, allow it to equilibrate to room temperature for no more than 4 hr before administration
Storage
Unopened vial (including IV solution stabilizer)
- Refrigerate at 2-8°C (36-46°F)
- Store in original carton to protect from light
- Do not freeze
- Do not shake
Reconstituted vials
- Does not contain bacteriostatic preservatives
- Do not store; use reconstituted solution immediately
Diluted solution
- Store at room temperature (20-25°C [68-77°F]) for up to 4 hr OR
- Refrigerate at 2-8°C (36-46°F) for up to 24 hr
- Protect from light
- Do not freeze
- Do not shake
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Lumoxiti intravenous - | 1 mg vial |  |
Copyright © 2010 First DataBank, Inc.
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