Ibritumomab tiuxetan (Zevalin)

==General information==
Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). Y-90 emits beta radiation, which causes cellular damage via free radicals. This results in damage to cells which express the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35).Ibritumomab tiuxetan (Zevalin) package insert Ibritumomab tiuxetan (Zevalin) package insert (locally hosted backup)Zevalin manufacturer's website
Route: IV
Extravasation: potential vesicant
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is established (work in progress)==
*Indolent lymphoma (FDA, PMDA)
**Follicular lymphoma (EMA, FDA, PMDA)
**Marginal zone lymphoma
*Mantle cell lymphoma (PMDA)
*Transformed lymphoma (FDA)
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
==Patient drug information==
*Ibritumomab tiuxetan (Zevalin) package insert
*Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)
*Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)
==History of changes in FDA indication==
*2002-02-19: Granted FDA accelerated approval for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. (Based on Wiseman et al. 2002, Witzig et al. 2002a, Witzig et al. 2002b)
**2009-09-03: Granted FDA full approval; label expanded for the treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy. (Based on FIT)
==History of changes in EMA indication==
*2004-01-16: Initial authorization
*Uncertain date: [90Y]-radiolabelled Zevalin is indicated in adults as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
*Uncertain date: [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
==History of changes in PMDA indication==
*2008-01-25: Initial approval for the treatment of relapsed or refractory, CD20-positive lymphomas of the following: low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
==Also known as==
*Brand name: Zevalin
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-CD20 radioimmunoconjugates
Category:Radiotherapy medications
Category:Diffuse large B-cell lymphoma medications
Category:Follicular lymphoma medications
Category:Indolent lymphoma medications
Category:Mantle cell lymphoma medications
Category:Marginal zone lymphoma medications
Category:FDA approved in 2002
Category:EMA approved in 2004
Category:PMDA approved in 2008