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Zevalin (Ibritumomab Tiuxetan) - Summary

 
 



WARNINGS

Fatal Infusion Reactions: Deaths have occurred within 24 hours of Rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first Rituximab infusion (See WARNINGS and ADVERSE REACTIONS). Patients who develop severe infusion reactions should have Rituximab, In-111 ZEVALIN, and Y-90 ZEVALIN infusions discontinued and receive medical treatment.

Prolonged and Severe Cytopenias: Y-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. The ZEVALIN therapeutic regimen should not be administered to patients with >/= 25% lymphoma marrow involvement and/or impaired bone marrow reserve (See WARNINGS and ADVERSE REACTIONS).

Dosing

  • The prescribed, measured, and administered dose of Y-90 ZEVALIN should not exceed the absolute maximum allowable dose of 32.0 mCi (1184 MBq).
  • Y-90 ZEVALIN should not be administered to patients with altered biodistribution as determined by imaging with In-111 ZEVALIN.
In-111 ZEVALIN and Y-90 ZEVALIN are radiopharmaceuticals and should be used only by physicians and other professionals qualified by training and experienced in the safe use and handling of radionuclides.

 

ZEVALIN SUMMARY

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 Indium-111 or Yttrium-90.

ZEVALIN, as part of the ZEVALIN therapeutic regimen (see DOSAGE AND ADMINISTRATION), is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab refractory follicular non-Hodgkin's lymphoma. Determination of the effectiveness of the ZEVALIN therapeutic regimen in a relapsed or refractory patient population is based on overall response rates (see CLINICAL STUDIES). The effects of the ZEVALIN therapeutic regimen on survival are not known.


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NEWS HIGHLIGHTS

Media Articles Related to Zevalin (Ibritumomab Tiuxetan)

Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2014.03.14]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/14/2014 12:00:00 AM

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Published Studies Related to Zevalin (Ibritumomab Tiuxetan)

Quantitative PCR analysis for Bcl-2/IgH in a phase III study of Yttrium-90 Ibritumomab Tiuxetan as consolidation of first remission in patients with follicular lymphoma. [2009.12.20]
PURPOSE The randomized First-Line Indolent Trial (FIT) was conducted in patients with advanced follicular lymphoma (FL), to evaluate the safety and efficacy of yttrium-90 ((90)Y) ibritumomab tiuxetan given as consolidation of complete or partial remission... CONCLUSION Eradication of PCR-detectable disease occurred more frequently after treatment with (90)Y-ibritumomab tiuxetan and was associated with prolongation of PFS.

Dosimetry of 90Y-ibritumomab tiuxetan as consolidation of first remission in advanced-stage follicular lymphoma: results from the international phase 3 first-line indolent trial. [2009.11]
The objective of this analysis was to assess the radiation exposure associated with (90)Y-ibritumomab tiuxetan when used as consolidation therapy in adults with low or minimal tumor burden after first-line therapy of advanced follicular lymphoma (FL)... CONCLUSION: In patients with low or minimal residual tumor burden after first-line chemotherapy of advanced FL, whole-body and bone marrow exposure after (90)Y-ibritumomab tiuxetan consolidation showed a significant positive correlation with progression-free survival, whereas dosimetric data could not predict hematologic toxicity.

Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma. [2008.11.10]
PURPOSE: We conducted an international, randomized, phase III trial to evaluate the efficacy and safety of consolidation with yttrium-90 ((90)Y)-ibritumomab tiuxetan in patients with advanced-stage follicular lymphoma in first remission... CONCLUSION: Consolidation of first remission with (90)Y-ibritumomab tiuxetan in advanced-stage follicular lymphoma is highly effective with no unexpected toxicities, prolonging PFS by 2 years and resulting in high PR-to-CR conversion rates regardless of type of first-line induction treatment.

Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. [2008.11.01]
CONCLUSIONS: In patients with previously untreated, symptomatic or bulky FL, short-course chemoimmunotherapy and consolidation RIT and extended rituximab resulted in a high CR rate. Failure to achieve an early PET CR after CHOP-R indicated high risk of relapse.

Weight-based dosing of Yttrium 90 ibritumomab tiuxetan in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. [2007.09]
BACKGROUND: Ibritumomab tiuxetan radioimmunotherapy produces durable remissions in patients with relapsed/refractory indolent non-Hodgkin lymphoma. The dosing of Yttrium 90 (90Y)-ibritumomab tiuxetan is based on patient weight and platelet count: 0.4 mCi/kg in patients with a count >or= 150 x 10(9)/L, to a maximum dose of 32 mCi. Patients weighing > 80 kg with platelet counts of >or= 150 x 10(9)/L receive a lower dose per unit of body weight. We evaluated whether this influences the safety or efficacy of treatment... CONCLUSION: The dose of 90Y ibritumomab tiuxetan was < 0.4 mCi/kg in 39% of patients, owing to the 32-mCi dose cap, but the efficacy or safety of 90Y ibritumomab tiuxetan in patients > 80 kg was not affected.

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Clinical Trials Related to Zevalin (Ibritumomab Tiuxetan)

Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma [Active, not recruiting]

- The purpose of this study is to find out whether combining a short course of

chemotherapy (Fludarabine, Mitoxantrone and Rituximab) followed by Zevalin will be effective in treating relapsed mantle cell lymphoma.

- The secondary purposes of the study are to determine the safety and to evaluate whether

there is additional benefit from Zevalin therapy following the chemotherapy.

Zevalin´┐Ż First Line in Follicular Lymphoma [Recruiting]
This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin«) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). For patients with complete clinical remission but persistent molecular disease subsequent to 90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to eradicate minimal residual disease.

A Safety and Efficacy Study of Fixed Dose Radioimmunotherapy (Zevalin, Yttrium-90 Ibritumomab Tiuxetan) for Patients With Incomplete Response to Chemotherapy Prior to Autologous Stem Cell Transplant for Multiple Myeloma [Recruiting]
The study involves the use of a targeted form of radiation, in addition to standard high dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is designed to kill more multiple myeloma cells while avoiding the side effects of standard radiation. This type of targeted radiation (also known as radioimmunotherapy) has been approved by the Food and Drug Administration (FDA) for the treatment of a related disease, lymphoma under the trade name, Zevalin┬ę. Zevalin┬ę has been added to high dose chemotherapy and stem cell transplants for patients with lymphoma and is now being studied in this clinical trial for patients with multiple myeloma. This trial is only available at Tufts Medical Center.

The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe and effective when integrated into a standard regimen of myeloablative chemotherapy and autologous stem cell rescue in patients with measurable disease prior to high dose chemotherapy and autologous stem cell transplant for multiple myeloma.

Safety of Ibritumomab Tiuxetan (Zevalin«) in Combination With a Fludarabine-Based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007) [Recruiting]
The purpose of this study is to evaluate the safety and efficacy of Zevalin« in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma [Not yet recruiting]
This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.

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Reports of Suspected Zevalin (Ibritumomab Tiuxetan) Side Effects

White Blood Cell Count Decreased (11)Platelet Count Decreased (11)Myelodysplastic Syndrome (9)Sepsis (8)Neutrophil Count Decreased (7)Anaemia (6)Febrile Neutropenia (6)Neoplasm Malignant (6)Herpes Zoster (5)Pancytopenia (5)more >>


Page last updated: 2014-03-14

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