DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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.


See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zevalin (Ibritumomab Tiuxetan)

Co-Founder Of Microsoft Diagnosed With Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.17]
Paul Allen who co-founded the computer giant Microsoft with Bill Gates in the 1970s has been diagnosed with Non-Hodgkin's Lymphoma, 25 years after surviving Hodgkin's lymphoma. The news was announced in a memo to the staff of Allen's company Vulcan, by CEO Jody Allen, who is also Paul Allen's sister. A copy of the memo was also sent to the media.

Pivotal Data Published In The Journal Cancer Demonstrate That TREANDA Induced Durable Responses In Relapsed Indolent Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.06]
Cephalon, Inc. (Nasdaq: CEPH) announced the journal Cancer has published a pivotal study demonstrating that TREANDA® (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab.

New Data On Bendamustine Offers Hope To Non-Hodgkin's Lymphoma Patients Resistant To Standard Therapy
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.06]
New data published today in the journal, Cancer, reveals that three quarters (75%) of patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), responded to treatment with Bendamustine following a single-arm, multicentre study. Significantly, all patients participating in the study had become resistant or were unresponsive to rituximab (the standard treatment for the disease) when used either as a single agent or in combination with other therapies. Professor Brad S.

Folotyn Approved for Aggressive Type of Non-Hodgkin's Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.09.28]
Title: Folotyn Approved for Aggressive Type of Non-Hodgkin's Lymphoma
Category: Health News
Created: 9/25/2009 12:10:00 PM
Last Editorial Review: 9/28/2009

FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.

more news >>

Published Studies Related to Zevalin (Ibritumomab Tiuxetan)

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.

Long-term responses in patients with recurring or refractory B-cell non-Hodgkin lymphoma treated with yttrium 90 ibritumomab tiuxetan. [2007.05.01]
BACKGROUND: Radioimmunotherapy with radiolabeled monoclonal antibodies to CD20 produces a high response rate in patients with recurring non-Hodgkin lymphoma (NHL), but the durability of those remissions is not well defined... CONCLUSIONS: A single dose of 90Y ibritumomab tiuxetan can produce durable responses and prolonged overall survival in a substantial number of patients in whom previous therapies have failed. Copyright (c) 2007 American Cancer Society

Yttrium 90-labeled ibritumomab tiuxetan radioimmunotherapy produces high response rates and durable remissions in patients with previously treated B-cell lymphoma. [2004.09]
We report updated time-to-event variables of a phase III randomized study comparing yttrium 90-labeled ibritumomab with rituximab standard therapy in 143 rituximab-naive patients with relapsed or refractory low-grade, follicular, or transformed CD20+ non-Hodgkin's lymphoma (NHL)... These results confirm that 90Y ibritumomab tiuxetan produces high response rates and durable remissions in patients with previously treated low-grade, follicular, and transformed NHL.

more studies >>

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.

Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma [Active, not recruiting]
Primary Objectives:

1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or MALT of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.

2. To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.

3. To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.

Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma [Completed]

Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma [Completed]
The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin’s Lymphoma (NHL) or relapsed Non-Hodgkin’s lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.

Autologous Stem Cell Transplantation (ASCT) With Zevalin Plus BuCyE in B-Cell Non-Hodgkin's Lymphoma (NHL) [Active, not recruiting]
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen would improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.

more trials >>

Page last updated: 2009-11-17

-- advertisement -- The American Red Cross
We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2009