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. Most (80%) fatalities occurred with the first rituximab infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Discontinue rituximab and Y-90 Zevalin infusions in patients who develop severe infusion reactions.
Prolonged and Severe Cytopenias: Y-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 Zevalin to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen. Discontinue rituximab and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].
Dosing: The dose of Y-90 Zevalin should not exceed 32.0 mCi (1184 MBq) [see Dosage and Administration (2.2)].
|
| |
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.
Relapsed or Refractory, Low-grade or Follicular NHL
Zevalin is indicated for the treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
Previously Untreated Follicular NHL
Zevalin is indicated for the treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy.
|
|
NEWS HIGHLIGHTSMedia Articles Related to Zevalin (Ibritumomab Tiuxetan)
Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2017.03.03]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/3/2017 12:00:00 AM
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.
Clinical Trials Related to Zevalin (Ibritumomab Tiuxetan)
Fixed Dose Radioimmunotherapy (Zevalin) for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma [Completed]
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©. Zevalin© 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.
Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma [Completed]
- 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 Post-marketing Surveillance in Japan [Recruiting]
This study is a regulatory post marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received Zevalin for relapsed or
refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The
objective of this study is to assess safety and efficacy of using Zevalin in clinical
practice. This study is also all case investigation of which the enrollment period is five
years, and all patients who received Zevalin will be recruited and followed 13 weeks after
the administration.
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas [Completed]
The goal of this clinical research study is to find out if giving (Rituxan) rituximab with
90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma.
The safety of this combination treatment will also be studied.
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan [Completed]
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in
Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess
biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin
is injected to the patient for the actual treatment. The objective of this study is to
assess appropriateness and necessity of revision of the standardized criteria for image
interpretation of In-111 Zevalin by comparing assessment by the investigator and the members
of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be
recruited.
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: 2017-03-03
|
