Prescription medicine
Ibritumomab tiuxetan Brand names: Zevalin
Ibritumomab tiuxetan (Zevalin) is a prescription medicine with an FDA approval on record since 2002. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ibritumomab tiuxetan FDA label on DailyMed (effective April 25, 2023, Acrotech Biopharma Inc); the BLA 125019 record on Drugs@FDA; every ibritumomab tiuxetan label on DailyMed.
Highlights of the record
FDA label of April 25, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ) ]. […]
Used for
From the label: indications and usageZevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) ( 1.1 ).
Forms and strengths
Kit.
On the market
- Earliest approval on file
- February 19, 2002 Zevalin, Spectrum Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,521 through July 30, 2026
What is ibritumomab tiuxetan used for?
From the label: indications and usageZevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) ( 1.1 ). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy ( 1.2 ). 1.1 Relapsed or Refractory, Low-grade or Follicular NHL Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). 1.2 Previously Untreated Follicular NHL Zevalin is indicated for the treatment of previously untreated follicular NHL in adult patients who achieve a partial or complete response to first-line chemotherapy. […]
Conditions named in the indications of ibritumomab tiuxetan's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Zevalin), BLA125019 (Spectrum Pharms), as published by Acrotech Biopharma Inc, effective April 25, 2023 (SPL set 25d367dc-da65-44c9-a844-1bf15339c285), via openFDA; the full label on DailyMed
Is there a generic for ibritumomab tiuxetan (Zevalin)?
No generic ibritumomab tiuxetan is approved (Drugs@FDA, October 8, 2026).
- 2002 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ibritumomab tiuxetan label say about other medicines?
The ibritumomab tiuxetan label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Rituximab | boxed warning | SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS See full prescribing information for complete boxed warning Serious Infusion Reactions, some fatal, may occur within 24 hours of rituximab infusion. … |
Source: FDA drug label (Zevalin), BLA125019 (Spectrum Pharms), as published by Acrotech Biopharma Inc, effective April 25, 2023 (SPL set 25d367dc-da65-44c9-a844-1bf15339c285), via openFDA; the full label on DailyMed
What do FAERS reports show for ibritumomab tiuxetan?
The FDA Adverse Event Reporting System holds 1,521 reports that list ibritumomab tiuxetan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 551 are coded as a death and 609 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Ibritumomab tiuxetan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other