Ibritumomab Tiuxetan
Generic Name: ibritumomab tiuxetan
Brand Names:
Zevalin
11 DESCRIPTION Zevalin (ibritumomab tiuxetan) is the immunoconjugate resulting from a stable thiourea covalent bond between the monoclonal antibody ibritumomab and the linker-chelator tiuxetan [N-[2-bis(carboxymethyl) amino]-3-(p-isothiocyanatophenyl)-propyl]-[N-[2-bis(carboxymethyl)amino]-2- (methyl)-ethyl]glycine. This linker-chelator provides a high affinity, conformationally restricted chelation site for Yttrium-90. The approximate molecular weight of ibritumomab tiuxetan is 148 kD.
Overview
11 DESCRIPTION Zevalin (ibritumomab tiuxetan) is the immunoconjugate resulting from a stable thiourea covalent bond between the monoclonal antibody ibritumomab and the linker-chelator tiuxetan [N-[2-bis(carboxymethyl) amino]-3-(p-isothiocyanatophenyl)-propyl]-[N-[2-bis(carboxymethyl)amino]-2- (methyl)-ethyl]glycine. This linker-chelator provides a high affinity, conformationally restricted chelation site for Yttrium-90. The approximate molecular weight of ibritumomab tiuxetan is 148 kD.
Uses
1 INDICATIONS AND USAGE 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 ). 1.1 Relapsed or Refractory, Low-grade or Follicular NHL Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Side Effects
6 ADVERSE 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.
Interactions
7 DRUG INTERACTIONS Patients receiving medications that interfere with platelet function or coagulation should have more frequent laboratory monitoring for thrombocytopenia. No formal drug interaction studies have been performed with Zevalin. Monitor patients receiving medications that interfere with platelet function or coagulation more frequently for thrombocytopenia. ( 7 )
Warnings
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. 5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS None. None.
Pregnancy
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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 72893-007-04). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive.
Frequently Asked Questions
What is Ibritumomab Tiuxetan used for?▼
1 INDICATIONS AND USAGE 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 ). 1.1 Relapsed or Refractory, Low-grade or Follicular NHL Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
What are the side effects of Ibritumomab Tiuxetan?▼
6 ADVERSE 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.
Can I take Ibritumomab Tiuxetan during pregnancy?▼
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.
What are the important warnings for Ibritumomab Tiuxetan?▼
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. 5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS None. None.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.