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Molecule

Ibritumomab tiuxetan

Available on requestBiologicOrphanCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Ibritumomab tiuxetan is a prescription medicine indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), among other approved uses. It is available as kits. MedsAcross supplies Ibritumomab tiuxetan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
19 February 2002
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Dosage forms
Kit
Biologic
Yes

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Zevalin 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). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy.

Source: US FDA prescribing information

How it works

Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (K D ) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM. The CD20 antigen is expressed on pre-B and mature B lymphocytes and on > 90% of B-cell non-Hodgkin’s lymphomas (NHL). The CD20 antigen is not shed from the cell surface and does not internalize upon antibody binding. The chelate tiuxetan, which tightly binds Y-90, is covalently linked to ibritumomab. The beta emission from Y-90 induces cellular damage by the formation of free radicals in the target and neighboring cells.

Source: US FDA prescribing information

Dosing overview

Day 1: Administer rituximab 250 mg/m 2 intravenous infusion. Day 7, 8, or 9: Administer rituximab 250 mg/m 2 intravenous infusion. If platelets at least 150,000/mm 3: Within 4 hours after rituximab infusion, administer 0.4 mCi/kg (14.8 MBq per kg) Y-90 Zevalin intravenous infusion. If platelets 100,000 to 149,000/mm 3 in relapsed or refractory patients: Within 4 hours after rituximab infusion, administer 0.3 mCi/kg (11.1 MBq per kg) Y-90 Zevalin intravenous infusion.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning: 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. Serious Infusion Reactions: Immediately discontinue rituximab and Y-90 Zevalin. Prolonged and Severe Cytopenias: Do not administer Zevalin to patients with ≥ 25% lymphoma marrow involvement or impaired bone marrow reserve. Severe Cutaneous and Mucocutaneous Reactions: Discontinue rituximab and Zevalin infusions if patients develop severe cutaneous or mucocutaneous reactions.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the label: Serious Infusion Reactions. Prolonged and Severe Cytopenias. Severe Cutaneous and Mucocutaneous Reactions. Leukemia and Myelodysplastic Syndrome. Common adverse reactions ( > 10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia.

Source: US FDA prescribing information

Interactions

Patients receiving medications that interfere with platelet function or coagulation should have more frequent laboratory monitoring for thrombocytopenia. No formal drug interaction studies have been performed with Zevalin. Monitor patients receiving medications that interfere with platelet function or coagulation more frequently for thrombocytopenia.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Ibritumomab tiuxetan, sorted by availability.

MedicineManufacturerRegisterAvailability
Zevalin kit Cold chainAcrotech BiopharmaUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 19 February 2002Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Ibritumomab tiuxetan available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Ibritumomab tiuxetan and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Ibritumomab tiuxetan have?

The catalogue lists 1 brand names for Ibritumomab tiuxetan, including Zevalin.

Is Ibritumomab tiuxetan approved by the US FDA?

Yes. The US FDA first approved Ibritumomab tiuxetan on 19 February 2002, according to Drugs@FDA.

Does Ibritumomab tiuxetan need cold chain shipping?

At least one listed presentation of Ibritumomab tiuxetan must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. Zevalin prescribing information (Acrotech Biopharma). U.S. National Library of Medicine, DailyMed. Retrieved 25 April 2023

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