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LABELS · c1ec6e37-45bb-4cda-a821-464552c48982

Zevalin

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2023-04-25
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: 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 ) ]. Dosing: The dose of Y-90 Zevalin should not exceed 32 mCi (1184 MBq) [ see Dosage and Administration ( 2.2 ) ]. 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. ( 5.1 ) Prolonged and Severe Cytopenias occur in most patients. ( 5.2 ) Severe Cutaneous and Mucocutaneous Reactions, some fatal, reported with Zevalin therapeutic regimen. ( 5.3 , 6.2 ) Do not exceed 32 mCi (1184 MBq) of Y-90 Zevalin. ( 2.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE 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) ( 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.
Full extracted label fields
application numbers
  1. BLA125019
boxed warning exact
  1. WARNING: 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 ) ]. Dosing: The dose of Y-90 Zevalin should not exceed 32 mCi (1184 MBq) [ see Dosage and Administration ( 2.2 ) ]. 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. ( 5.1 ) Prolonged and Severe Cytopenias occur in most patients. ( 5.2 ) Severe Cutaneous and Mucocutaneous Reactions, some fatal, reported with Zevalin therapeutic regimen. ( 5.3 , 6.2 ) Do not exceed 32 mCi (1184 MBq) of Y-90 Zevalin. ( 2.2 )
brand names
  1. Zevalin
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25d367dc-da65-44c9-a844-1bf15339c285
generic names
  1. IBRITUMOMAB TIUXETAN
id
c1ec6e37-45bb-4cda-a821-464552c48982
indications and usage exact
  1. 1 INDICATIONS AND USAGE 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) ( 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.
indications and usage tables exact
    is original packager
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    manufacturer names
    1. Acrotech Biopharma Inc
    matched search terms
    1. lymphoma
    package ndcs
    1. 72893-007-04
    product ndcs
    1. 72893-007
    product types
    1. HUMAN PRESCRIPTION DRUG
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          source url
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          spl effective date
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          spl effective time
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              Drugs@FDA application source records
              1. application number
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                payload
                all indexed label documents
                1. Appl No
                  125019
                  Application Docs Date
                  2004-03-30 00:00:00
                  Application Docs ID
                  18731
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                  0
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                  1
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                  ORIG
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                  Application Docs Date
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                  0
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                  Submission No
                  194
                  Submission Type
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                4. Appl No
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                6. Appl No
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                  0
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                7. Appl No
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                  Application Docs Date
                  2005-09-15 00:00:00
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                  39780
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  92
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                8. Appl No
                  125019
                  Application Docs Date
                  2007-11-13 00:00:00
                  Application Docs ID
                  39781
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  132
                  Submission Type
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                9. Appl No
                  125019
                  Application Docs Date
                  2009-09-18 00:00:00
                  Application Docs ID
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                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  156
                  Submission Type
                  SUPPL
                10. Appl No
                  125019
                  Application Docs Date
                  2013-09-09 00:00:00
                  Application Docs ID
                  39783
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  210
                  Submission Type
                  SUPPL
                11. Appl No
                  125019
                  Application Docs Date
                  2013-09-09 00:00:00
                  Application Docs ID
                  39784
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  213
                  Submission Type
                  SUPPL
                12. Appl No
                  125019
                  Application Docs Date
                  2018-12-12 00:00:00
                  Application Docs ID
                  56714
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  227
                  Submission Type
                  SUPPL
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                  STANDARD
                  Submission Class Code ID
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                  AP
                  Submission Status Date
                  2018-12-11 00:00:00
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                2. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  213
                  Submission Status
                  AP
                  Submission Status Date
                  2013-08-30 00:00:00
                  Submission Type
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                  Submissions Public Notes
                3. Appl No
                  125019
                  Review Priority
                  Submission Class Code ID
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                  Submission No
                  210
                  Submission Status
                  AP
                  Submission Status Date
                  2013-08-30 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                4. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  2
                  Submission No
                  194
                  Submission Status
                  AP
                  Submission Status Date
                  2011-11-18 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                5. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  185
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                  AP
                  Submission Status Date
                  2010-12-16 00:00:00
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                  Submissions Public Notes
                6. Appl No
                  125019
                  Review Priority
                  PRIORITY
                  Submission Class Code ID
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                  Submission No
                  156
                  Submission Status
                  AP
                  Submission Status Date
                  2009-09-03 00:00:00
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                  Submissions Public Notes
                7. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
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                  Submission No
                  135
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                  AP
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                  2008-03-25 00:00:00
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                  Submissions Public Notes
                8. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  132
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                  AP
                  Submission Status Date
                  2007-11-02 00:00:00
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                  Submissions Public Notes
                9. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  117
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                  AP
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                  2007-01-04 00:00:00
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                  Submissions Public Notes
                10. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  92
                  Submission Status
                  AP
                  Submission Status Date
                  2005-09-13 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                11. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
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                  Submission No
                  88
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                  AP
                  Submission Status Date
                  2005-07-27 00:00:00
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                  SUPPL
                  Submissions Public Notes
                12. Appl No
                  125019
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  70
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                  Submission Status Date
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                  Submissions Public Notes
                application number
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                approval interpretation
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                current indication status
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                true
                latest approved submission date
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                latest label selection rule
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                latest posted label documents
                1. Appl No
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                  Application Docs Date
                  2018-12-12 00:00:00
                  Application Docs ID
                  56714
                  Application Docs Title
                  0
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                  Submission No
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                Appl No
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                Sponsor Name
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                openfda application present
                true
                products
                1. Active Ingredient
                  IBRITUMOMAB TIUXETAN
                  Appl No
                  125019
                  Drug Name
                  ZEVALIN
                  Form
                  INJECTABLE; INJECTION
                  Product No
                  001
                  Reference Drug
                  0
                  Reference Standard
                  Strength
                  3.2MG/2ML
                  marketing status
                  1. Prescription

              Source passages and status connections

              Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

              Passage 1 · positive indication candidate
              application numbers
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              brand names
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              exact text
              1 INDICATIONS AND USAGE 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) ( 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 (NH
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                  1 INDICATIONS AND USAGE 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) ( 1.1 ). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy ( 1.2 ).
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                  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 chemot
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                          Preserved source evidence · Not medical advice