Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 3.2mg/2mL
Non-Hodgkin Lymphoma
Day 1
- Initiate the ibritumomab therapeutic regimen following recovery of platelet counts to ≥150,000/mm³ at least 6 weeks, but no more than 12 weeks, following the last dose of first-line chemotherapy
- Administer acetaminophen 650 mg PO and diphenhydramine 50 mg PO to premedicate prior to rituximab infusion
- Administer 250 mg/m² IV rituximab infusion at initial rate of 50 mg/hr; may increase rate by 50 mg/hr q30min to 400 mg/hr maximum; discontinue if severe reaction occurs
- Administer 5 mCi of In-111 ibritumomab tiuxetan over 10 minutes within 4 hr of rituximab infusion
- Assess biodistribution by imaging 48-72 hr postadministration
Day 7, 8, or 9
- Verify that expected biodistribution is present
- Premedicate with acetaminophen 650 mg PO and diphenhydramine 50 mg PO prior to rituximab infusion
- Administer 250 mg/m² rituximab at initial rate of 100 mg/hr; increase rate by 100 mg/hr q30min; not to exceed 400 mg/hr
- Platelet count >150,000 cells/mm³: Administer 0.4 mCi/kg of Y-90 ibritumomab tiuxetan as 10 minutes IVP within 4 hr of rituximab infusion; not to exceed 32 mCi Y-90 ibritumomab tiuxetan regardless of patient weight
- Platelet count 100,000-149,000 cells/mm³: Administer 0.3 mCi/kg ibritumomab tiuxetan over 10 min; not to exceed 32 mCi Y-90 ibritumomab tiuxetan regardless of patient weight
- Platelet count <100,000 cells/mm³: Do not administer
Monitor
qWeek CBC, platelet counts following therapeutic regimen until levels recover
Other Indications & Uses
Relapsed or refractory low-grade, follicular or transformed B-cell non-Hodgkin's lymphoma
Safety & efficacy not established
Adverse Effects
>10%
Thrombocytopenia (95%)
Neutropenia (77%)
Anemia (61%)
Asthenia (43%)
Nausea (31%)
Infections (29%)
Chills (24%)
Fever (17%)
Abd pain (16%)
Pain (13%)
Vomiting (12%)
HA (12%)
1-10%
Cough (10%)
Dizziness (10%)
Diarrhea (9%)
Pruritus (9%)
Rash (8%)
Anorexia (8%)
Back pain (8%)
Edema (8%)
Arthralgia (7%)
Myalgia (7%)
Hypotension (6%)
Flushing (6%)
Constipation (5%)
Urticaria (4%)
Anxiety (4%)
Dyspepsia (4%)
Secondary malignancy (2%)
Warnings
Black Box Warnings
The drug should be administered under the supervision of a cancer chemotherapy physician qualified by training and experienced in the safe use and handling of radionuclides
Fatal infusion reaction symptoms including hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock have occurred within 24 hr of rituximab infusion (~80% occurred in association with the first infusion); discontinue infusions and provide medical treatment to patients who experience infusion reactions
Y-90 ibritumomab tiuxetan administration results in severe and prolonged cytopenias in most patients
Do not administer to patients with greater than or equal to 25% lymphoma marrow involvement and/or impaired bone marrow reserve
Do not exceed absolute maximum allowable dose of 32.0 mCi (1184 MBq) for Y-90 ibritumomab tiuxetan
Do not administer Y-90 ibritumomab tiuxetan to patients with altered biodistribution as determined by imaging with In-111 ibritumomab tiuxetan
Severe cutaneous and mucocutaneous reactions, some with fatal outcome, may occur in association with the ibritumomab tiuxetan therapeutic regimen
Do not administer to patients experiencing a severe cutaneous or mucocutaneous reaction and provide prompt medical evaluation
Contraindications
Hypersensitivity to any component (incl rituximab, yttrium chloride, indium chloride), murine proteins or to another monoclonal antibody
Patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve
Platelets <100 K/mm³, ANC <1500/mm³
Do NOT administer Y-90 ibritumomab to patients with altered biodistribution as determined by In-111 ibritumomab imaging
Hypocellular bone marrow, failed stem cell collection history, myeloablative therapy history
Pregnancy
Cautions
Patients with prior treatment with murine proteins should be screened for human anti-mouse antibodies
Rituximab dose is lower when coadministered with ibritumomab than when use as a single agent
Effective contraception should be used during and for up to 12 months after treatment
Discontinue if patient develops infusion reaction symptom complex including hypoxia, pulmonary infiltrates, ARDS, MI, ventricular fibrillation, or cardiogenic shock
Risk of severe and prolonged cytopenias; some complicated by hemorrhage and severe infection
Risk of potentially fatal mucocutaneous reactions
Live viral vaccine use, murine protein exposure history
Drug not supplied radiolabeled, radiolabeling must be done in specialized facility
Development of leukemia and myelodysplastic syndrome may occur; monitor patients for hematological toxicity including secondary malignancies
Monitor for extravasation and terminate infusion if it occurs; resume infusion in another limb
Do not administer live viral vaccines to patients who recently received therapy
May cause fetal harm; advise patients of potential risk to a fetus and to use effective contraception
Pregnancy & Lactation
Pregnancy
Therapy may cause fetal harm when administered to a pregnant woman; immunoglobulins are known to cross the placenta; there are no available data on therapy use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage; advise women of childbearing potential to use adequate contraception for a minimum of twelve months; inform women who become pregnant while receiving therapy of the potential fetal risks
Reproductive potential
- Therapy may cause fetal harm when administered to a pregnant woman
Pregnancy testing
- Conduct pregnancy testing in females of reproductive potential prior to treatment
Contraception
- Females: Advise patients of reproductive potential to use effective contraceptive methods during treatment and for 12 months after last dose of therapeutic regimen
- Males: Advise patients with female partners of reproductive potential to use effective contraceptive methods during treatment and for 12 months after the final dose of therapeutic regimen
Infertility
- Based on its radioactivity, there is potential risk that therapeutic regimen could cause toxic effects on male and female gonads
Lactation
There are no data on presence of drug or metabolites in human milk, effects on breastfed child, or effects on milk production; because human IgG is excreted in human milk, it is expected that the drug would be present in human milk; due to potential for serious adverse reactions in a breastfeeding child, advise lactating women to avoid breastfeeding during treatment and for 6 months after last dose of therapeutic regimen
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
Recombinant monoclonal antibody against CD20 (lymphocyte antigen) complexed with radiotherapeutic agent; promotes antibody-dependent lysis and free radical damage
Pharmacokinetics
Half-Life: 30 hr
Metabolism: unknown
Excretion: urine
Administration
IV Preparation
Follow Mfr directions
IV Administration
Follow Mfr directions
Storage
Store at 2C-8C (36F-46F)
Protect from freezing
Images
Formulary
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