Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 424aedac-a777-40a3-b6d3-a8fe7e305b79

Elitek

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
2026-07-30
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS See full prescribing information for complete boxed warning . Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs ( 4 , 5.1 , 6.2 ). Hemolysis: Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek if hemolysis occurs. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek therapy ( 4 , 5.2 ). Methemoglobinemia: Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek if methemoglobinemia occurs ( 4 , 5.3 ). Interference with uric acid measurements: Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection ( 5.4 ). Hypersensitivity Reactions Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4) , Warnings and Precautions (5.1) , Adverse Reactions (6.2) ] . Hemolysis Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see Contraindications (4) , Warnings and Precautions (5.2) ] . Methemoglobinemia Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see Contraindications (4) , Warnings and Precautions (5.3) ] . Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection [see Warnings and Precautions (5.4) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1) ] .
Full extracted label fields
application numbers
  1. BLA103946
boxed warning exact
  1. WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS See full prescribing information for complete boxed warning . Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs ( 4 , 5.1 , 6.2 ). Hemolysis: Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek if hemolysis occurs. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek therapy ( 4 , 5.2 ). Methemoglobinemia: Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek if methemoglobinemia occurs ( 4 , 5.3 ). Interference with uric acid measurements: Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection ( 5.4 ). Hypersensitivity Reactions Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4) , Warnings and Precautions (5.1) , Adverse Reactions (6.2) ] . Hemolysis Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see Contraindications (4) , Warnings and Precautions (5.2) ] . Methemoglobinemia Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see Contraindications (4) , Warnings and Precautions (5.3) ] . Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection [see Warnings and Precautions (5.4) ] .
brand names
  1. Elitek
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ae10bc4-6b65-402f-9db5-2d7753054922
generic names
  1. RASBURICASE
id
424aedac-a777-40a3-b6d3-a8fe7e305b79
indications and usage exact
  1. 1 INDICATIONS AND USAGE Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1) ] .
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Sanofi-Aventis U.S. LLC
    matched search terms
    1. lymphoma
    2. leukemia
    3. tumor
    package ndcs
    1. 0024-5150-10
    2. 0024-5154-11
    3. 0024-5152-11
    4. 0024-5151-75
    5. 0024-5155-74
    6. 0024-5153-74
    product ndcs
    1. 0024-5150
    2. 0024-5151
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
        rxcuis
        1. 1790344
        2. 1790347
        3. 1790349
        4. 1790351
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.json
        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
        results
        limit
        100
        skip
        200
        total
        830
        sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22424aedac-a777-40a3-b6d3-a8fe7e305b79%22
        spl effective date
        2026-07-30
        spl effective time
        20260730
        spl set id
        0ae10bc4-6b65-402f-9db5-2d7753054922
        spl version
        25
        substance names
          uniis
            verification flags
            1. oncology_keyword_candidate_not_clinically_classified
            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
              BLA103946
              payload
              all indexed label documents
              1. Appl No
                103946
                Application Docs Date
                2007-10-04 00:00:00
                Application Docs ID
                18673
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5049
                Submission Type
                SUPPL
              2. Appl No
                103946
                Application Docs Date
                2004-03-12 00:00:00
                Application Docs ID
                39731
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              3. Appl No
                103946
                Application Docs Date
                2005-01-26 00:00:00
                Application Docs ID
                39732
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5017
                Submission Type
                SUPPL
              4. Appl No
                103946
                Application Docs Date
                2009-10-19 00:00:00
                Application Docs ID
                39733
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5083
                Submission Type
                SUPPL
              5. Appl No
                103946
                Application Docs Date
                2015-05-27 00:00:00
                Application Docs ID
                39734
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5095
                Submission Type
                SUPPL
              6. Appl No
                103946
                Application Docs Date
                2016-06-17 00:00:00
                Application Docs ID
                39735
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5097
                Submission Type
                SUPPL
              7. Appl No
                103946
                Application Docs Date
                2017-09-18 00:00:00
                Application Docs ID
                49759
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5101
                Submission Type
                SUPPL
              8. Appl No
                103946
                Application Docs Date
                2019-12-13 00:00:00
                Application Docs ID
                61272
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5103
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5103
                Submission Status
                AP
                Submission Status Date
                2019-12-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5101
                Submission Status
                AP
                Submission Status Date
                2017-09-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5097
                Submission Status
                AP
                Submission Status Date
                2016-06-13 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5095
                Submission Status
                AP
                Submission Status Date
                2015-05-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5094
                Submission Status
                AP
                Submission Status Date
                2015-02-03 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                2
                Submission No
                5083
                Submission Status
                AP
                Submission Status Date
                2009-10-16 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5049
                Submission Status
                AP
                Submission Status Date
                2007-09-10 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5047
                Submission Status
                AP
                Submission Status Date
                2007-02-28 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                103946
                Review Priority
                Submission Class Code ID
                6
                Submission No
                5039
                Submission Status
                AP
                Submission Status Date
                2007-09-10 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5017
                Submission Status
                AP
                Submission Status Date
                2004-12-15 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                103946
                Review Priority
                STANDARD
                Submission Class Code ID
                7
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                2002-07-12 00:00:00
                Submission Type
                ORIG
                Submissions Public Notes
              application number
              BLA103946
              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
              2019-12-12
              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
                103946
                Application Docs Date
                2019-12-13 00:00:00
                Application Docs ID
                61272
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5103
                Submission Type
                SUPPL
              official application record
              Appl No
              103946
              Appl Public Notes
              Appl Type
              BLA
              Sponsor Name
              SANOFI SYNTHELABO
              openfda application present
              true
              products
              1. Active Ingredient
                RASBURICASE
                Appl No
                103946
                Drug Name
                ELITEK
                Form
                VIAL; INTRAVENOUS
                Product No
                001
                Reference Drug
                0
                Reference Standard
                Strength
                1.5MG/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. BLA103946
            brand names
            1. Elitek
            classification reasons
            1. explicit_positive_indication_predicate
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            500
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receivi
            label id
            424aedac-a777-40a3-b6d3-a8fe7e305b79
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-fe46cb484bb7326efaaa
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. RASBURICASE
            id
            ind-span-32f9b34d762704eea62e
            label id
            424aedac-a777-40a3-b6d3-a8fe7e305b79
            positive predicate support span
            end
            43
            end exclusive
            true
            exact text
            is indicated
            label id
            424aedac-a777-40a3-b6d3-a8fe7e305b79
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
            start
            31
            qualifier mentions
            1. context exact
              ed for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor
              kind
              age
              polarity
              not_inferred
              span
              end
              110
              end exclusive
              true
              exact text
              pediatric
              label id
              424aedac-a777-40a3-b6d3-a8fe7e305b79
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
              start
              101
            2. context exact
              tial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who a
              kind
              age
              polarity
              not_inferred
              span
              end
              129
              end exclusive
              true
              exact text
              adult patients
              label id
              424aedac-a777-40a3-b6d3-a8fe7e305b79
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
              start
              115
            regulatory links
              schema version
              0.1.0
              source batch sha256
              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
              source defined aliases
                source span
                end
                300
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
                label id
                424aedac-a777-40a3-b6d3-a8fe7e305b79
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22424aedac-a777-40a3-b6d3-a8fe7e305b79%22
                spl effective date
                2026-07-30
                spl set id
                0ae10bc4-6b65-402f-9db5-2d7753054922
                spl version
                25
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                tumor_directed_candidate
                Passage 2 · positive indication candidate
                application numbers
                1. BLA103946
                brand names
                1. Elitek
                classification reasons
                1. explicit_positive_indication_predicate
                2. tumor_or_malignant_hematology_words_in_positive_statement
                clinical review status
                pending
                content role
                positive_indication_candidate
                context span
                end
                801
                end exclusive
                true
                exact text
                pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (
                label id
                424aedac-a777-40a3-b6d3-a8fe7e305b79
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                start
                101
                current approval status
                not_reconciled
                duplicate text group
                dup-bd77d05fdd200817bb82
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. RASBURICASE
                id
                ind-span-646d85ab64e0edc2c4ab
                label id
                424aedac-a777-40a3-b6d3-a8fe7e305b79
                positive predicate support span
                end
                348
                end exclusive
                true
                exact text
                is a recombinant urate-oxidase indicated
                label id
                424aedac-a777-40a3-b6d3-a8fe7e305b79
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                start
                308
                qualifier mentions
                1. context exact
                  icated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  411
                  end exclusive
                  true
                  exact text
                  pediatric
                  label id
                  424aedac-a777-40a3-b6d3-a8fe7e305b79
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                  start
                  402
                2. context exact
                  tial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who a
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  430
                  end exclusive
                  true
                  exact text
                  adult patients
                  label id
                  424aedac-a777-40a3-b6d3-a8fe7e305b79
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                  start
                  416
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                  source defined aliases
                    source span
                    end
                    601
                    end exclusive
                    true
                    exact text
                    Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
                    label id
                    424aedac-a777-40a3-b6d3-a8fe7e305b79
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                    start
                    301
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22424aedac-a777-40a3-b6d3-a8fe7e305b79%22
                    spl effective date
                    2026-07-30
                    spl set id
                    0ae10bc4-6b65-402f-9db5-2d7753054922
                    spl version
                    25
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    tumor_directed_candidate
                    Passage 3 · positive indication candidate
                    application numbers
                    1. BLA103946
                    brand names
                    1. Elitek
                    classification reasons
                    1. explicit_positive_indication_predicate
                    2. no_tumor_directed_keyword_in_positive_statement
                    clinical review status
                    pending
                    content role
                    positive_indication_candidate
                    context span
                    end
                    809
                    end exclusive
                    true
                    exact text
                    pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1) ] .
                    label id
                    424aedac-a777-40a3-b6d3-a8fe7e305b79
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                    start
                    402
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-709e86ba049bbf4a9918
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. RASBURICASE
                    id
                    ind-span-744a4e13c021fff98e4e
                    label id
                    424aedac-a777-40a3-b6d3-a8fe7e305b79
                    positive predicate support span
                    end
                    647
                    end exclusive
                    true
                    exact text
                    is indicated
                    label id
                    424aedac-a777-40a3-b6d3-a8fe7e305b79
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                    start
                    635
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                        source defined aliases
                          source span
                          end
                          686
                          end exclusive
                          true
                          exact text
                          ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment.
                          label id
                          424aedac-a777-40a3-b6d3-a8fe7e305b79
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                          start
                          602
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%22424aedac-a777-40a3-b6d3-a8fe7e305b79%22
                          spl effective date
                          2026-07-30
                          spl set id
                          0ae10bc4-6b65-402f-9db5-2d7753054922
                          spl version
                          25
                          structured fields status
                          not_extracted_no_values_inferred_from_mentions
                          structured indication
                          age
                          Source null
                          approval pathway
                          Source null
                          biomarker and test
                          Source null
                          disease stage
                          Source null
                          limitations
                          Source null
                          line
                          Source null
                          prior therapy
                          Source null
                          regimen
                          Source null
                          tumor histology
                          Source null
                          use intent
                          non_oncology_or_unclear_candidate
                          Passage 4 · positive indication candidate
                          application numbers
                          1. BLA103946
                          brand names
                          1. Elitek
                          classification reasons
                          1. explicit_positive_indication_predicate
                          2. no_tumor_directed_keyword_in_positive_statement
                          3. positive_statement_also_contains_qualification_review_required
                          clinical review status
                          pending
                          content role
                          positive_indication_candidate
                          context span
                          end
                          809
                          end exclusive
                          true
                          exact text
                          o are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1) ] .
                          label id
                          424aedac-a777-40a3-b6d3-a8fe7e305b79
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                          start
                          487
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-198e023acbd34da1032f
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. RASBURICASE
                          id
                          ind-span-2fef2348ba8b2b6d5c91
                          label id
                          424aedac-a777-40a3-b6d3-a8fe7e305b79
                          positive predicate support span
                          end
                          731
                          end exclusive
                          true
                          exact text
                          is indicated
                          label id
                          424aedac-a777-40a3-b6d3-a8fe7e305b79
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                          start
                          719
                          qualifier mentions
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                              source defined aliases
                                source span
                                end
                                809
                                end exclusive
                                true
                                exact text
                                ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1) ] .
                                label id
                                424aedac-a777-40a3-b6d3-a8fe7e305b79
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                300f1b50d84024123a7ed68d096b5099ea9df783d204e1ed9030bcc1e2db352f
                                start
                                687
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%22424aedac-a777-40a3-b6d3-a8fe7e305b79%22
                                spl effective date
                                2026-07-30
                                spl set id
                                0ae10bc4-6b65-402f-9db5-2d7753054922
                                spl version
                                25
                                structured fields status
                                not_extracted_no_values_inferred_from_mentions
                                structured indication
                                age
                                Source null
                                approval pathway
                                Source null
                                biomarker and test
                                Source null
                                disease stage
                                Source null
                                limitations
                                Source null
                                line
                                Source null
                                prior therapy
                                Source null
                                regimen
                                Source null
                                tumor histology
                                Source null
                                use intent
                                non_oncology_or_unclear_candidate

                                Preserved source evidence · Not medical advice