There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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=====Condition1=====
* Dosing Information
:* Dosage
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There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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|offLabelPedNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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* Condition1
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|warnings=
* Description
====Precautions====
* Description
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|clinicalTrials=
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
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|postmarketing=
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
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=====Endocrine=====
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=====Metabolic and Nutritional=====
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=====Urogenital=====
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<!--Drug Interactions-->
|drugInteractions=
* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=
* '''Pregnancy Category'''
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
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|administration=
* Oral
* Intravenous
|monitoring=
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
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|IVCompat=
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
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===Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
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*
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*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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|PD=
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
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|PK=
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
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|nonClinToxic=
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
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|clinicalStudies=
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--How Supplied-->
|howSupplied=
==Overview==
*
'''Ibritumomab tiuxetan''', also sold under the trade name '''Zevalin®''', is a [[monoclonal antibody therapy|monoclonal antibody]] [[radioimmunotherapy]] treatment for some forms of [[B cell]] [[non-Hodgkin's lymphoma]], a [[myeloproliferative disorder]] of the [[lymphatic system]]. The drug uses the monoclonal mouse [[IgG|IgG1]] [[antibody]] ibritumomab (pronounced as <ih bri TYOO mo mab>) <ref>pronunciation: ibritumomab[http://body.aol.com/drugs/ibritumomab]</ref> in conjunction with the [[chelator]] [[tiuxetan]], to which a radioactive isotope (either [[yttrium]]-90 or [[indium]]-111) is added.
==Mechanism of action==
<!--Patient Counseling Information-->
The antibody binds to the [[CD20]] [[antigen]] found on the surface of normal and malignant [[B cell]]s (but not B cell precursors), allowing radiation from the attached [[isotope]] (mostly [[beta radiation|beta emission]]) to kill it and some nearby cells. In addition, the antibody itself may trigger cell death via [[cytotoxicity|antibody-dependent cell-mediated cytotoxicity]] (ADCC), [[cytotoxicity|complement-dependent cytotoxicity]] (CDC), and [[apoptosis]]. Together, these actions eliminate B cells from the body, allowing a new population of healthy B cells to develop from [[lymphoid]] [[stem cell]]s.
==Administration==
|fdaPatientInfo=
In order to qualify for Zevalin, a patient needs to have bone marrow involvement of < 25%<ref>Indications [http://www.zevalin.com/HealthCarePro/indications.htm]</ref> and > 15% bone marrow cellularity. Since Zevalin is known to cause cytopenias, platelet and neutrophil counts are also taken pretreatment. Since a murine antibody is used, the patient might also be tested for Human Anti Mouse Antibodies ([[HAMA]]). Having bulky disease does not disqualify a patient.
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
The Zevalin regimen takes 7-9 days, with two administrations of Zevalin. Each dose is preceded by [[Rituxan]], in order to pre-deplete B lymphocytes.<ref>Dosing and Administration[http://www.zevalin.com/HealthCarePro/dosingandadministration.htm]</ref> The dose of Rituxan given here is less than the usual dose.
<!--Precautions with Alcohol-->
The first dose uses Indium-111 Zevalin for imaging. Indium-111 emits some [[gamma radiation]], which can be picked up by the [[gamma camera]]. A scan is done to assess biodistribution<ref>Biodistribution</ref> of the drug. This test dose is used to determine that no excess amounts go to the marrow, liver, etc. in this particular patient.
|alcohol=
If the gamma scan shows no altered biodistribution, then the second dose is given, using Yttrium-90 Zevalin as the actual treatment. Yttrium<ref>Sound file - pronunciation Yttrium[http://www.webelements.com/webelements/elements/media/snds/Y.au]</ref>-90 emits the cell-killing [[beta radiation]].
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Ibritumomab tiuxetan is administered by [[intravenous infusion]] which usually lasts around 10 minutes. Only acrylic shielding is needed, not lead.
<!--Brand Names-->
==Efficacy==
|brandNames=
Treatment with Zevalin showed higher response rates in [[clinical trial]]s compared to treatment with only [[Rituxan]] (similar to Zevalin, but without the attached radioisotope), and showed very promising results for patients who no longer respond to Rituxan.
* ®<ref>{{Cite web | title = | url = }}</ref>
In patients With Relapsed or Refractory Low-Grade, Follicular, or Transformed B-cell NHL, where ''no prior anti-CD20 therapy was allowed'', the OR was 80% / 50% and CR was 34% / 20%, comparing Zevalin to Rituxan.
However, in a Phase II study on Zevalin with the more aggressive [[Mantle Cell Lymphoma]], the OR was only 42% and CR was 26%<ref>Zevalin and Mantle Cell[http://www.abstracts2view.com/hem4806/view.php?nu=HEM06L1_1029]</ref>.
|lookAlike=
==History==
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
Developed by the IDEC Pharmaceuticals, which is now part of [[Biogen Idec]], ibritumomab tiuxetan was the first radioimmunotherapy drug approved by the [[Food and Drug Administration]] (FDA) in 2002 to treat cancer.
In August 2007, [[Cell Therapeutics Inc]] announced plans to buy the U.S. rights to sell, market, and distribute this radioactive antibody from Biogen for approximately US$30 million, or the equivalent of about two years' net sales revenue in the U.S. for the drug.[http://news.yahoo.com/s/ap/20070816/ap_on_sc/cell_therapeutics] Outside of the U.S., [[Bayer Schering]] continues to have the rights to the drug.
<!--Drug Shortage Status-->
==Costs==
|drugShortage=
Zevalin®, which is not available in a generic form because it is still under patent protection, is currently the most expensive drug available given in a single dose, costing over US$24,000 for the average dose. However, Zevalin is essentially an entire course of lymphoma therapy which is delivered in 7-9 days, with one visit for imaging, one visit for a gamma scan, and one visit for the actual therapeutic dose. Compared to other [[monoclonal antibody]] treatments (many of which are well over US$40,000 for a course of therapy), this drug is priced in the middle for many of these therapies.
}}
==See also==
<!--Pill Image-->
* [[Bexxar]], an alternative radioimmunotherapy treatment for non-Hodgkin's lymphoma.
==External links==
{{PillImage
*[http://www.zevalin.com/ http://www.zevalin.com/ - Official Zevalin web site]
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
*[http://www.idecpharm.com/ http://www.idecpharm.com/ - Biogen IDEC web site]
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==References==
<!--Label Display Image-->
<references/>
{{mousemonoclonals}}
{{LabelImage
{{Radiopharmaceuticals}}
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Ibritumomab tiuxetan is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ibritumomab tiuxetan in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibritumomab tiuxetan in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Ibritumomab tiuxetan in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ibritumomab tiuxetan in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibritumomab tiuxetan in pediatric patients.
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ibritumomab tiuxetan in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ibritumomab tiuxetan in the drug label.
