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LABELS · d1acb9d5-9241-4aeb-b3e7-f05dbc8c15a2

Kineret

Open original source → · Download preserved record

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
2026-04-03
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 ) 1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). KINERET can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents [see Warnings and Precautions ( 5.2 )]. 1.2 Cryopyrin-Associated Periodic Syndromes (CAPS) KINERET is indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID). 1.3 Deficiency of Interleukin-1 Receptor Antagonist (DIRA) KINERET is indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Full extracted label fields
application numbers
  1. BLA103950
boxed warning exact
    brand names
    1. Kineret
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9d74915-6606-4570-9c52-c4001d3177de
    generic names
    1. ANAKINRA
    id
    d1acb9d5-9241-4aeb-b3e7-f05dbc8c15a2
    indications and usage exact
    1. 1 INDICATIONS AND USAGE KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 ) 1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). KINERET can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents [see Warnings and Precautions ( 5.2 )]. 1.2 Cryopyrin-Associated Periodic Syndromes (CAPS) KINERET is indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID). 1.3 Deficiency of Interleukin-1 Receptor Antagonist (DIRA) KINERET is indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Swedish Orphan Biovitrum AB (publ)
      matched search terms
      1. tumor
      package ndcs
      1. 66658-234-07
      2. 66658-234-28
      product ndcs
      1. 66658-234
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration, Administration ( 2.5 ) 10/2025 Warnings and Precautions, Amyloidosis ( 5.5 ) 10/2025
      record type
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      routes
      1. SUBCUTANEOUS
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      2. 727714
      source batch
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      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
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      sha256
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      url
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      source url
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      spl effective date
      2026-04-03
      spl effective time
      20260403
      spl set id
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      spl version
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      substance names
      1. ANAKINRA
      uniis
      1. 9013DUQ28K
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        BLA103950
        payload
        all indexed label documents
        1. Appl No
          103950
          Application Docs Date
          2004-03-17 00:00:00
          Application Docs ID
          18693
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          103950
          Application Docs Date
          2004-03-17 00:00:00
          Application Docs ID
          18694
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5013
          Submission Type
          SUPPL
        3. Appl No
          103950
          Application Docs Date
          2012-12-28 00:00:00
          Application Docs ID
          18695
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5136
          Submission Type
          SUPPL
        4. Appl No
          103950
          Application Docs Date
          2016-05-23 00:00:00
          Application Docs ID
          18696
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5175
          Submission Type
          SUPPL
        5. Appl No
          103950
          Application Docs Date
          2004-10-21 00:00:00
          Application Docs ID
          39750
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5039
          Submission Type
          SUPPL
        6. Appl No
          103950
          Application Docs Date
          2011-09-30 00:00:00
          Application Docs ID
          39751
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5116
          Submission Type
          SUPPL
        7. Appl No
          103950
          Application Docs Date
          2013-10-25 00:00:00
          Application Docs ID
          39752
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5150
          Submission Type
          SUPPL
        8. Appl No
          103950
          Application Docs Date
          2018-06-11 00:00:00
          Application Docs ID
          54497
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5182
          Submission Type
          SUPPL
        9. Appl No
          103950
          Application Docs Date
          2020-12-21 00:00:00
          Application Docs ID
          65627
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5189
          Submission Type
          SUPPL
        10. Appl No
          103950
          Application Docs Date
          2024-09-23 00:00:00
          Application Docs ID
          79686
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5198
          Submission Type
          SUPPL
        11. Appl No
          103950
          Application Docs Date
          2025-10-28 00:00:00
          Application Docs ID
          83938
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5197
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5198
          Submission Status
          AP
          Submission Status Date
          2024-09-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
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          Submission Status
          AP
          Submission Status Date
          2025-10-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          103950
          Review Priority
          PRIORITY
          Submission Class Code ID
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          5189
          Submission Status
          AP
          Submission Status Date
          2020-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          6
          Submission No
          5183
          Submission Status
          AP
          Submission Status Date
          2020-02-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5182
          Submission Status
          AP
          Submission Status Date
          2018-06-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5177
          Submission Status
          AP
          Submission Status Date
          2016-11-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5175
          Submission Status
          AP
          Submission Status Date
          2016-05-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5150
          Submission Status
          AP
          Submission Status Date
          2013-10-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          103950
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          5136
          Submission Status
          AP
          Submission Status Date
          2012-12-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          103950
          Review Priority
          Submission Class Code ID
          6
          Submission No
          5116
          Submission Status
          AP
          Submission Status Date
          2011-09-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5079
          Submission Status
          AP
          Submission Status Date
          2008-10-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          103950
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5064
          Submission Status
          AP
          Submission Status Date
          2006-12-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA103950
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
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        has approved submission record
        true
        latest approved submission date
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        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
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          Application Docs Date
          2025-10-28 00:00:00
          Application Docs ID
          83938
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          5197
          Submission Type
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        official application record
        Appl No
        103950
        Appl Public Notes
        Appl Type
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        Sponsor Name
        BIOVITRUM AB
        openfda application present
        true
        products
        1. Active Ingredient
          ANAKINRA
          Appl No
          103950
          Drug Name
          KINERET
          Form
          VIAL; SUBCUTANEOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          10MIU/VIAL
          marketing status
          1. Prescription
        2. Active Ingredient
          ANAKINRA
          Appl No
          103950
          Drug Name
          KINERET
          Form
          VIAL; SUBCUTANEOUS
          Product No
          002
          Reference Drug
          0
          Reference Standard
          Strength
          18MIU/VIAL
          marketing status
          1. Prescription
        3. Active Ingredient
          ANAKINRA
          Appl No
          103950
          Drug Name
          KINERET
          Form
          VIAL; SUBCUTANEOUS
          Product No
          003
          Reference Drug
          0
          Reference Standard
          Strength
          25MIU/VIAL
          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
      1. BLA103950
      brand names
      1. Kineret
      classification reasons
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      clinical review status
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      context span
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      821
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      true
      exact text
      1 INDICATIONS AND USAGE KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 ) 1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA
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          1 INDICATIONS AND USAGE KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 )
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          t of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 ) 1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). KINERET can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents [see Warnings and Precautions ( 5.2 )]. 1.2 Cryopyrin-Associated Periodic Syndromes (CAP
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              1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs).
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