Ibritumomab Tiuxetan

Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (K D ) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM.

• Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) ( 1.1 ). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy ( 1.2 ).ICD-10: C85.90

• None. None.contraindicated

Day 1 : Administer rituximab 250 mg/m 2 intravenous infusion. ( 2.2 ) Day 7, 8, or 9 : Administer rituximab 250 mg/m 2 intravenous infusion. ( 2.2 ) If platelets at least 150,000/mm 3 : Within 4 hours after rituximab infusion, administer 0.4 mCi/kg (14.8 MBq per kg) Y-90 Zevalin intravenous infusion. If platelets 100,000 to 149,000/mm 3 in relapsed or refractory patients: Within 4 hours after rituximab infusion, administer 0.3 mCi/kg (11.1 MBq per kg) Y-90 Zevalin intravenous infusion. 2.1 Recommended Dosing Schedule Administer the Zevalin therapeutic regimen as outlined below. Initiate the Zevalin therapeutic regimen following recovery of platelet counts to 150,000/mm 3 or more at least 6 weeks, but no more than 12 weeks, following the last dose of first-line chemotherapy. Only administer rituximab/Zevalin in facilities where immediate access to resuscitative measures is available. Overview of Dosing Schedule Zevalin Dosing Schedule 2.2 Zevalin Therapeutic Regimen Dosage and Administration Day 1: Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion. Administer rituximab 250 mg/m 2 intravenously at an initial rate of 50 mg/hr. In the absence of infusion reactions, escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. Do not mix or dilute rituximab with other drugs. Immediately stop the rituximab infusion for serious infusion reactions and discontinue the Zevalin therapeutic regimen [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ].

Serious Infusion Reactions: Immediately discontinue rituximab and Y-90 Zevalin. ( 5.1 , 6.1 ) Prolonged and Severe Cytopenias: Do not administer Zevalin to patients with ≥ 25% lymphoma marrow involvement or impaired bone marrow reserve. ( 5.2 , 6.1 ) Severe Cutaneous and Mucocutaneous Reactions: Discontinue rituximab and Zevalin infusions if patients develop severe cutaneous or mucocutaneous reactions. ( 5.3 , 6.2 ) Development of Leukemia and Myelodysplastic Syndrome: Monitor patients for hematological toxicity including secondary malignancies. ( 5.4 , 6.1 ) Extravasation: Monitor for extravasation and terminate infusion if it occurs. Resume infusion in another limb. ( 5.5 , 6.2 ) Immunization: Do not administer live viral vaccines to patients who recently received Zevalin. ( 5.6 ) Embryo-fetal Toxicity: May cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Serious Infusion Reactions Rituximab, alone or as a component of the Zevalin therapeutic regimen, can cause severe, including fatal, infusion reactions. These reactions typically occur during the first rituximab infusion with time to onset of 30 to 120 minutes. Signs and symptoms of severe infusion reactions may include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, and cardiogenic shock. Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions.

The following serious adverse reactions are discussed in greater detail in other sections of the label: Serious Infusion Reactions [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] . Prolonged and Severe Cytopenias [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ]. Severe Cutaneous and Mucocutaneous Reactions [ see Boxed Warning and Warnings and Precautions ( 5.3 ) ]. Leukemia and Myelodysplastic Syndrome [ see Warnings and Precautions ( 5.4 ) ]. Common adverse reactions ( > 10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-866-298-8433 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The reported safety data reflects exposure to Zevalin in 349 patients with relapsed or refractory, low-grade, follicular or transformed NHL across 5 trials (4 single arm and 1 randomized) and in 206 patients with previously untreated follicular NHL in a randomized trial (FIT study) who received any portion of the Zevalin therapeutic regimen.

Lactation: Advise women not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its radioactivity, Y-90 Zevalin may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Immunoglobulins are known to cross the placenta. There are no available data on Zevalin 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 Zevalin of the potential fetal risks. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. 8.2 Lactation Risk Summary There are no data on the presence of Zevalin or its metabolites in human milk, the effects of Zevalin on the breastfed child, or its effects on milk production. Because human IgG is excreted in human milk, it is expected that Zevalin would be present in human milk.

Metabolism

Pharmacokinetic and biodistribution studies were performed using In-111 Zevalin (5 mCi [185 MBq] In-111, 1.6 mg ibritumomab tiuxetan). In an early study designed to assess the need for pre-administration of unlabeled antibody, only 18% of known sites of disease were imaged when In-111 Zevalin was administered without unlabeled ibritumomab.

Severe cytopenias which may require stem cell support have occurred at doses higher than the recommended maximum total dose of 32 mCi (1184 MBq).

• Feb 19, 2002BLABLA125019Spectrum Pharms

1. 1Thrombocytopenia17411%
2. 2Sepsis17211%
3. 3Neutropenia1419.3%
4. 4Meningitis Tuberculous1288.4%
5. 5Myelodysplastic Syndrome986.4%
6. 6Febrile Neutropenia946.2%
7. 7Off Label Use936.1%
8. 8Progressive Multifocal Leukoencephalopathy905.9%
9. 9Disease Progression855.6%
10. 10Anaemia845.5%
11. 11Platelet Count Decreased845.5%
12. 12White Blood Cell Count Decreased835.5%
13. 13Pancytopenia785.1%
14. 14Pneumonia734.8%
15. 15Mucosal Inflammation724.7%

The 10 most recently updated of 107 ClinicalTrials.gov registrations naming Ibritumomab Tiuxetan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
  Completed · Phase 2 · Interventional · 30 enrolled · Centre Antoine Lacassagne
  NCT00690560updated 2026-05-22
• Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma
  Terminated · Phase 3 · Interventional · 20 enrolled · Mayo Clinic
  NCT02320292updated 2025-07-09
• S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
  Completed · Phase 2 · Interventional · 159 enrolled · SWOG Cancer Research Network
  NCT01359592updated 2025-06-17
• A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan
  Completed · Phase 2 · Interventional · 41 enrolled · City of Hope Medical Center
  NCT00577278updated 2024-02-16
• Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation
  Completed · Phase 1 · Phase 2 · Interventional · 26 enrolled · University of Nebraska
  NCT00031642updated 2023-12-27
• A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)
  Unknown · Phase 3 · Interventional · 159 enrolled · Fondazione Italiana Linfomi - ETS
  NCT01827605updated 2023-12-14
• Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
  Completed · Phase 2 · Interventional · 34 enrolled · TerSera Therapeutics LLC
  NCT04189588updated 2023-10-06
• Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
  Completed · Phase 4 · Interventional · 12 enrolled · Biogen
  NCT00168727updated 2023-08-23
• Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
  Unknown · Phase 2 · Interventional · 20 enrolled · Joseph Tuscano
  NCT01811368updated 2022-11-30
• Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas
  Completed · Phase 2 · Interventional · 31 enrolled · M.D. Anderson Cancer Center
  NCT00493467updated 2022-09-15

Frequently asked questions

How does Ibritumomab Tiuxetan work?

Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (K D ) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM.

What is Ibritumomab Tiuxetan used for?

According to FDA labeling, Ibritumomab Tiuxetan carries indications including: Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) ( 1.1 ). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy ( 1.2 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ibritumomab Tiuxetan?

Ibritumomab Tiuxetan is classified as CD20-directed Radiotherapeutic Antibody, CD20-directed Antibody Interactions, Radiopharmaceutical Activity, Increased B Lymphocyte Destruction, Increased Immunologically Active Molecule Degradation.

What are the contraindications for Ibritumomab Tiuxetan?

Ibritumomab Tiuxetan labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.