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LABELS · 29ba86b1-f672-482e-e063-6394a90a931f

PROLEUKIN

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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
2024-12-20
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer Proleukin in a hospital setting with an intensive care facility. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.1) ] . Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat pre-existing bacterial infections prior to initiation of Proleukin therapy and withhold Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.3) ] . WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITY, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS) including life-threatening or fatal reactions, has occurred in patients treated with Proleukin. Administer Proleukin in a hospital setting with an intensive care unit. Withhold or discontinue Proleukin as recommended. ( 2.4 , 4 , 5.1 ) Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended. ( 2.4 , 5.2 ) Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat preexisting bacterial infections prior to initiating Proleukin and withhold Proleukin as recommended. ( 2.4 , 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.
Full extracted label fields
application numbers
  1. BLA103293
boxed warning exact
  1. WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer Proleukin in a hospital setting with an intensive care facility. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.1) ] . Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat pre-existing bacterial infections prior to initiation of Proleukin therapy and withhold Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.3) ] . WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITY, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS) including life-threatening or fatal reactions, has occurred in patients treated with Proleukin. Administer Proleukin in a hospital setting with an intensive care unit. Withhold or discontinue Proleukin as recommended. ( 2.4 , 4 , 5.1 ) Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended. ( 2.4 , 5.2 ) Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat preexisting bacterial infections prior to initiating Proleukin and withhold Proleukin as recommended. ( 2.4 , 5.3 )
brand names
  1. PROLEUKIN
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f3c516ad-d405-4fbe-af6a-962080dbfa7d
generic names
  1. ALDESLEUKIN
id
29ba86b1-f672-482e-e063-6394a90a931f
indications and usage exact
  1. 1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Iovance Biotherapeutics, Inc
    matched search terms
    1. carcinoma
    2. melanoma
    package ndcs
    1. 73776-022-01
    product ndcs
    1. 73776-022
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      complete_spl_indications_section_candidate
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      1. INTRAVENOUS
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      2. 307816
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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.
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      url
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      source url
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      spl effective date
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      substance names
      1. ALDESLEUKIN
      uniis
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      Drugs@FDA application source records
      1. application number
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        payload
        all indexed label documents
        1. Appl No
          103293
          Application Docs Date
          2012-07-30 00:00:00
          Application Docs ID
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          Submission No
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        2. Appl No
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          Application Docs Date
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          Application Docs ID
          75636
          Application Docs Title
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          Application Docs Type ID
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          Submission No
          5154
          Submission Type
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        all submission records
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          STANDARD
          Submission Class Code ID
          3
          Submission No
          5154
          Submission Status
          AP
          Submission Status Date
          2023-09-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          103293
          Review Priority
          STANDARD
          Submission Class Code ID
          3
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          5146
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          Submission Status Date
          2019-05-17 00:00:00
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          Submissions Public Notes
        3. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5139
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          Submission Status Date
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        4. Appl No
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          STANDARD
          Submission Class Code ID
          3
          Submission No
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          Submission Status Date
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          Submission Type
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        5. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          5123
          Submission Status
          AP
          Submission Status Date
          2011-12-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          103293
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          103293
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
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          Submission Status
          AP
          Submission Status Date
          2010-07-06 00:00:00
          Submission Type
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          Submissions Public Notes
        8. Appl No
          103293
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5088
          Submission Status
          AP
          Submission Status Date
          2010-03-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          103293
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5087
          Submission Status
          AP
          Submission Status Date
          2009-04-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          103293
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1029
          Submission Status
          AP
          Submission Status Date
          2000-06-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          103293
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1021
          Submission Status
          AP
          Submission Status Date
          1998-01-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          103293
          Review Priority
          UNKNOWN
          Submission Class Code ID
          2
          Submission No
          1019
          Submission Status
          AP
          Submission Status Date
          1998-01-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA103293
        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2023-09-29
        latest label selection rule
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        latest posted label documents
        1. Appl No
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          Application Docs Date
          2023-10-02 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          5154
          Submission Type
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        official application record
        Appl No
        103293
        Appl Public Notes
        Appl Type
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        Sponsor Name
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        openfda application present
        true
        products
        1. Active Ingredient
          ALDESLEUKIN
          Appl No
          103293
          Drug Name
          PROLEUKIN
          Form
          VIAL
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          22MIU/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. BLA103293
      brand names
      1. PROLEUKIN
      classification reasons
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      exact text
      1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.
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          1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma.
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          1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treat
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              ( 1.1 ) The treatment of adults with metastatic melanoma.
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