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LABELS · 56f50d8e-7c87-4119-a7dc-bfd77fa3dcec

IFEX

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
2024-12-02
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ] . • Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ] . • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ] . WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning . • Myelosuppression can be severe and lead to fatal infections ( 5.1 ) • Encephalopathy can be severe and may result in death ( 5.2 ) • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. ( 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
Full extracted label fields
application numbers
  1. NDA019763
boxed warning exact
  1. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ] . • Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ] . • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ] . WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning . • Myelosuppression can be severe and lead to fatal infections ( 5.1 ) • Encephalopathy can be severe and may result in death ( 5.2 ) • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. ( 5.3 )
brand names
  1. IFEX
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7241707-7538-4d1a-91e7-3a25a91e0b9a
generic names
  1. IFOSFAMIDE
id
56f50d8e-7c87-4119-a7dc-bfd77fa3dcec
indications and usage exact
  1. 1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Baxter Healthcare Corporation
    matched search terms
    1. cancer
    package ndcs
    1. 0338-3991-01
    2. 0338-3993-01
    product ndcs
    1. 0338-3991
    2. 0338-3993
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning 12/2024 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 12/2024 Warnings and Precautions ( 5 ) 12/2024
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 1791588
    2. 1791591
    3. 1791593
    4. 1791595
    source batch
    file
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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
    https://api.fda.gov/drug/label.json?search=id%3A%2256f50d8e-7c87-4119-a7dc-bfd77fa3dcec%22
    spl effective date
    2024-12-02
    spl effective time
    20241202
    spl set id
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    spl version
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    substance names
    1. IFOSFAMIDE
    uniis
    1. UM20QQM95Y
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
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    Drugs@FDA application source records
    1. application number
      NDA019763
      payload
      all indexed label documents
      1. Appl No
        019763
        Application Docs Date
        2011-03-28 00:00:00
        Application Docs ID
        33914
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      2. Appl No
        019763
        Application Docs Date
        2012-03-06 00:00:00
        Application Docs ID
        33915
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      3. Appl No
        019763
        Application Docs Date
        2014-09-03 00:00:00
        Application Docs ID
        33916
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        19
        Submission Type
        SUPPL
      4. Appl No
        019763
        Application Docs Date
        2018-08-02 00:00:00
        Application Docs ID
        55079
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        20
        Submission Type
        SUPPL
      5. Appl No
        019763
        Application Docs Date
        2024-12-03 00:00:00
        Application Docs ID
        80476
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2024-12-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        20
        Submission Status
        AP
        Submission Status Date
        2018-07-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        19
        Submission Status
        AP
        Submission Status Date
        2014-08-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        17
        Submission Status
        AP
        Submission Status Date
        2012-03-01 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2011-03-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2001-11-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2001-09-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        1996-12-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        1996-01-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        1995-08-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        1995-06-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        1992-11-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA019763
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2024-12-02
      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
        019763
        Application Docs Date
        2024-12-03 00:00:00
        Application Docs ID
        80476
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      official application record
      Appl No
      019763
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      BAXTER HLTHCARE
      openfda application present
      true
      products
      1. Active Ingredient
        IFOSFAMIDE
        Appl No
        019763
        Drug Name
        IFEX
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        1GM/VIAL
        marketing status
        1. Prescription
      2. Active Ingredient
        IFOSFAMIDE
        Appl No
        019763
        Drug Name
        IFEX
        Form
        INJECTABLE;INJECTION
        Product No
        002
        Reference Drug
        1
        Reference Standard
        0
        Strength
        3GM/VIAL
        marketing status
        1. Prescription
      3. Active Ingredient
        IFOSFAMIDE; MESNA
        Appl No
        019763
        Drug Name
        IFEX/MESNEX KIT
        Form
        INJECTABLE;INJECTION
        Product No
        003
        Reference Drug
        0
        Reference Standard
        0
        Strength
        1GM/VIAL;100MG/ML
        marketing status
        1. Discontinued
      4. Active Ingredient
        IFOSFAMIDE; MESNA
        Appl No
        019763
        Drug Name
        IFEX/MESNEX KIT
        Form
        INJECTABLE;INJECTION
        Product No
        004
        Reference Drug
        0
        Reference Standard
        0
        Strength
        3GM/VIAL;100MG/ML
        marketing status
        1. Discontinued

    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. NDA019763
    brand names
    1. IFEX
    classification reasons
    1. explicit_positive_indication_predicate
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    context span
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    true
    exact text
    1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
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    dup-d39fb0fba85772e18267
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    generic names
    1. IFOSFAMIDE
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    qualifier mentions
    1. context exact
      1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic a
      kind
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      not_inferred
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      in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer
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        1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
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            structured indication
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            biomarker and test
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            limitations
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            Source null
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            Preserved source evidence · Not medical advice