Relapsed or refractory hairy cell leukemia in patients who have previously received ≥2 systemic therapies (including a purine nucleoside analog).
The antibody portion (moxetumumab) attaches to the CD22 antigen on the surface of tumor cells. A Pseudomonas exotoxin is linked to the antibody portion. The complex binds to CD22 on the surface of B cells and is internalized into the cell, which results in inhibition of protein synthesis and cell death.
Achievement of hematologic remission.
Absorption: IV administration results in complete bioavailability.
Distribution: Distributed to tissues.
Metabolism and Excretion: Broken down by catabolic processes into peptides and amino acids.
Half-life: 1.4 hr.
TIME/ACTION PROFILE (plasma concentrations)
- History of hemolytic uremic syndrome or severe thrombotic microangiopathy (↑ risk of hemolytic uremic syndrome)
- OB: Pregnancy (may cause fetal harm).
Use Cautiously in:
- Renal impairment
- Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
- Rep: Women of reproductive potential
- Pedi: Safety and effectiveness not established in children;
- Geri: ↑ risk of renal impairment in older adults.
Adverse Reactions/Side Effects
CV: CAPILLARY LEAK SYNDROME, edema, hypertension
EENT: blurred vision, cataracts, conjunctivitis, dry eye, ocular pain, periorbital edema
F and E: hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia
GI: constipation, diarrhea, hyperbilirubinemia, hypoalbuminemia, ↑ liver enzymes, nausea
GU: RENAL FAILURE, acute kidney injury, renal impairment
Hemat: HEMOLYTIC ANEMIA, HEMOLYTIC UREMIC SYNDROME, THROMBOCYTOPENIA, anemia
Misc: fatigue, fever, infusion reactions
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
IV (Adults): 0.04 mg/kg on Days 1, 3, and 5 of each 28–day cycle. Continue for a maximum of 6 cycles, or until disease progression or unacceptable toxicity.
Lyophilized powder for injection: 1 mg/vial
- Monitor weight and BP before each infusion. Assess for signs and symptoms of capillary leak syndrome (CLS) (weight gain [↑ 5.5 pounds (2.5 kg) or ≥5% from Day 1 of current cycle]), hypotension, peripheral edema, shortness of breath or cough, pulmonary edema and/or serosal effusions, hypoalbuminemia, ↑ hematocrit, leukocytosis, thrombocytosis) during therapy. Most cases occurred in first 8 days of cycle. If weight ↑ by 5.5 pounds (2.5 kg) or 5% or greater from Day 1 of cycle and patient is hypotensive, promptly check for peripheral edema, hypoalbuminemia, and respiratory symptoms. If CLS suspected, check for decrease in oxygen saturation and evidence of pulmonary edema and/or serosal effusions. For ≥Grade 2, provide supportive measures (oral or intravenous corticosteroids, monitoring of weight, albumin levels, BP) until resolution. For Grade 2, hold dose until recovery of symptoms. For Grade 3 or 4, discontinue Lumoxiti. May be fatal.
- Monitor for signs and symptoms of hemolytic uremic syndrome (HUS) (microangiopathic hemolytic anemia, thrombocytopenia, progressive renal failure) during therapy. Usually occurs in first 9 day of cycle. Treat with supportive measures and fluid replacement. Monitor blood chemistry, CBC, and renal function until resolution.
- Monitor for signs and symptoms of infusion related reactions (chills, cough, dizziness, dyspnea, feeling hot, flushing, headache, hypertension, hypotension, myalgia, nausea, fever, sinus tachycardia, tachycardia, vomiting, wheezing) during and after infusion. May occur during any cycle. If severe infusion related reaction occurs, interrupt infusion and institute treat symptoms. Administer oral or intravenous corticosteroids 30 min before resuming, or before next infusion.
Lab Test Considerations:
Obtain a negative pregnancy test before starting therapy.
- Monitor fluid balance and serum electrolytes before each dose, on Day 8 of each cycle and mid-cycle to avoid fluid overload and/or electrolyte abnormalities.
- Monitor blood chemistry with serum creatinine and CBC with platelet count before each dose, on Day 8 of each cycle and mid-cycle. If patient develops hemolytic anemia, worsening or sudden onset of thrombocytopenia, increase in creatinine levels, elevation of bilirubin and/or LDH, and has evidence of hemolysis based on peripheral blood smear schistocytes, consider HUS. If HUS suspected, promptly check blood LDH, indirect bilirubin, and blood smear schistocytes for evidence of hemolysis. If Grade 2 occurs, hold dose until recovery of symptoms. If Grade 3 or 4 occur, discontinue Lumoxiti. May be fatal. For ≥Grade 2 creatinine increases (>1.5 × baseline or ULN) in patients with baseline serum creatinine WNL, hold dose. Resume Lumoxiti upon recovery to Grade 1 (1-1.5 × baseline, or between ULN and 1.5 × ULN). For creatinine increases to ≥Grade 3 (>3 × baseline or ULN) in patients with baseline serum creatinine of Grades 1 or 2, delay dose. Resume Lumoxiti upon recovery to ≤baseline.
- Monitor renal function before each infusion and as indicated during therapy. Hold dose in patients with Grade ≥3 elevations in creatinine, or upon worsening from baseline by ≥2 grades.
- Deficient knowledge, related to medication regimen (Patient/Family/Teaching)
- High Alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order, calculations, and infusion pump settings.
- Administer 1 L or 0.5 L in patients <50 kg, of D5W, 0.45% NaCl or 0.9% NaCl over 2–4 hr before and after each Lumoxiti infusion.
- May administer low-dose aspirin on Days 1 through 8 of each 28–day cycle to prevent thrombosis.
- Premedicate with antihistamine (hydroxyzine or diphenhydramine), antipyretic (acetaminophen) and H2 receptor antagonist, 30–90 min before each infusion. Post-infusion: consider oral antihistamines and antipyretics for up to 24 hr after infusion. Administer oral corticosteroid (4 mg dexamethasone) to decrease nausea and vomiting. Maintain adequate oral fluid intake.
- Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. If powder or solution comes in contact with skin or mucosa, wash thoroughly with soap and water. Discard equipment in specially designated containers.
- Intermittent Infusion: Calculate dose and number of vials needed. Individualize dosing based on patient's actual body weight before 1st dose of 1st cycle; change doses only when change in weight >10%. Reconstitute each vial with 1.1 mL Sterile Water for Injection for a 1 mg/mL solution. Direct stream to walls of vial, not directly on powder. Swirl gently to mix until powder dissolved; do not shake. Solution is clear to slightly opalescent, colorless to slightly yellow; do not use if cloudy, discolored, or contains particulate matter. Use immediately; do not store reconstituted vial. Add 1 mL IV Solution Stabilizer to 50 mL bag of 0.9% NaCl. Invert gently to mix; do not shake. Inject Lumoxiti into infusion bag containing 50 mL 0.9% NaCl and 1 mL IV Solution Stabilizer. Gently invert to mix; do not shake. Discard partially used or empty vials. Solution is stable for 4 hr at room temperature or 24 hr if refrigerated. Protect from light; do not freeze.
- Rate: Allow solutions to reach room temperature for not >4 hr before infusing. Infuse over 30 min. Protect from light.
- Explain purpose of Lumoxiti to patient. Advise patient to read Medication Guide before starting and with each cycle in case of changes.
- Advise patient to hydrate with up to 3 L (twelve 8-oz glasses) of oral fluids (water, milk, juice) per 24 hr on Days 1 through 8 of each 28-day cycle. For patients <50 kg, up to 2 L (eight 8-oz glasses) per 24 hr is recommended.
- Advise patient to monitor weight at least weekly during therapy and to notify health care professional of significant changes.
- Advise patient to notify health care professional immediately if signs and symptoms of CLS (swelling of face, arms, or legs; fast weight gain [increase in 5.5 pounds from Day 1 of current cycle], weakness or dizziness, shortness of breath or trouble breathing, cough, low blood pressure) or HUS (decrease in amount of urine or dark urine, unusual bleeding or bruising of skin, stomach pain, vomiting, fever, feeling tired, changes in mood or behavior, confusion, seizures, shortness of breath, fast heartbeat) occur.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
- Advise patient to notify health care professional if signs and symptoms of infusion related reactions (chills, headache, cough, changes in BP, dizziness, muscle pain, shortness of breath or wheezing, nausea, feeling hot or flushing, fever, fast heartbeat, vomiting) or electrolyte problems (muscle cramps, nausea, numbness or tingling, seizures, abnormal or fast heartbeat) occur.
- Rep: May be teratogenic. Advise females of reproductive potential to use effective contraception during and for at least 30 days after last dose. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
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