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LABELS · 5959022d-c2d4-11ec-e063-6294a90a6cd6

Bilprevda

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
2026-08-18
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Bilprevda is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Bilprevda is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA761444
boxed warning exact
    brand names
    1. Bilprevda
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1f0590e-f5bb-44ac-99a0-4aa4596c7e54
    generic names
    1. DENOSUMAB
    id
    5959022d-c2d4-11ec-e063-6294a90a6cd6
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Bilprevda is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Bilprevda is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Organon LLC
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 78206-195-01
      product ndcs
      1. 78206-195
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2723338
        2. 2723345
        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
        results
        limit
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        skip
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        sha256
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        url
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        source url
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        spl effective date
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        spl effective time
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        spl set id
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        spl version
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        substance names
        1. DENOSUMAB
        uniis
        1. 4EQZ6YO2HI
        verification flags
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        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          BLA761444
          payload
          all indexed label documents
          1. Appl No
            761444
            Application Docs Date
            2025-10-07 00:00:00
            Application Docs ID
            83676
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761444
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84022
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761444
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-08-29 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761444
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2025-10-29 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          BLA761444
          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
          2025-10-29
          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
            761444
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84022
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            ORIG
          official application record
          Appl No
          761444
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          SHANGHAI HENLIUS BIOTECH
          openfda application present
          true
          products
          1. Active Ingredient
            DENOSUMAB-NXXP
            Appl No
            761444
            Drug Name
            BILDYOS
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            60MG/ML
            marketing status
            1. Prescription
          2. Active Ingredient
            DENOSUMAB-NXXP
            Appl No
            761444
            Drug Name
            BILPREVDA
            Form
            INJECTABLE;INJECTION
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            120MG/1.7ML(70MG/ML)
            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. BLA761444
        brand names
        1. Bilprevda
        classification reasons
        1. explicit_positive_indication_predicate
        2. supportive_or_complication_use_words
        clinical review status
        pending
        content role
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        context span
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        411
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        true
        exact text
        1 INDICATIONS AND USAGE Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Tr
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        is a RANK ligand (RANKL) inhibitor indicated
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        qualifier mentions
        1. context exact
          in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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            true
            exact text
            1 INDICATIONS AND USAGE Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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            spl effective date
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            Source null
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            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
            supportive_care_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. BLA761444
            brand names
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            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
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            593
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            true
            exact text
            S AND USAGE Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevent
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            is a RANK ligand (RANKL) inhibitor indicated
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            qualifier mentions
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              ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of
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              not_inferred
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              239
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              exact text
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            2. context exact
              ly mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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              unresectable or where surgical resection is lik
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                exact text
                ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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                rom solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone met
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                    l tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases
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                                      Preserved source evidence · Not medical advice