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LABELS · 66314b60-5135-400e-933a-d4974397fdaa

Jevtana

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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
2025-10-07
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 ( 4 , 5.1 , 5.2 ) Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy. ( 2.1 , 5.2 ) Contraindicated if history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80. ( 4 ) Neutropenia : Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 [see Contraindications (4) and Warnings and Precautions (5.1 , 5.2) ] . Severe hypersensitivity : Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.3) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 )
Full extracted label fields
application numbers
  1. NDA201023
boxed warning exact
  1. WARNING: NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 ( 4 , 5.1 , 5.2 ) Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy. ( 2.1 , 5.2 ) Contraindicated if history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80. ( 4 ) Neutropenia : Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 [see Contraindications (4) and Warnings and Precautions (5.1 , 5.2) ] . Severe hypersensitivity : Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.3) ] .
brand names
  1. Jevtana
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa
generic names
  1. CABAZITAXEL
id
66314b60-5135-400e-933a-d4974397fdaa
indications and usage exact
  1. 1 INDICATIONS AND USAGE JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Sanofi-Aventis U.S. LLC
    matched search terms
    1. cancer
    package ndcs
    1. 0024-5824-11
    2. 0024-5823-15
    3. 0024-5822-01
    product ndcs
    1. 0024-5824
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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        meta
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        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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        2026-09-09
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        source url
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        spl effective date
        2025-10-07
        spl effective time
        20251007
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        substance names
          uniis
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            Drugs@FDA application source records
            1. application number
              NDA201023
              payload
              all indexed label documents
              1. Appl No
                201023
                Application Docs Date
                2010-06-17 00:00:00
                Application Docs ID
                18987
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              2. Appl No
                201023
                Application Docs Date
                2012-10-05 00:00:00
                Application Docs ID
                18988
                Application Docs Title
                0
                Application Docs Type ID
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                Submission No
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                Submission Type
                SUPPL
              3. Appl No
                201023
                Application Docs Date
                2015-06-19 00:00:00
                Application Docs ID
                18989
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                15
                Submission Type
                SUPPL
              4. Appl No
                201023
                Application Docs Date
                2014-11-20 00:00:00
                Application Docs ID
                40049
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                11
                Submission Type
                SUPPL
              5. Appl No
                201023
                Application Docs Date
                2016-09-15 00:00:00
                Application Docs ID
                45364
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                17
                Submission Type
                SUPPL
              6. Appl No
                201023
                Application Docs Date
                2017-05-18 00:00:00
                Application Docs ID
                48447
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                20
                Submission Type
                SUPPL
              7. Appl No
                201023
                Application Docs Date
                2017-09-14 00:00:00
                Application Docs ID
                49736
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                19
                Submission Type
                SUPPL
              8. Appl No
                201023
                Application Docs Date
                2018-01-10 00:00:00
                Application Docs ID
                51020
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                21
                Submission Type
                SUPPL
              9. Appl No
                201023
                Application Docs Date
                2020-03-06 00:00:00
                Application Docs ID
                62068
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                23
                Submission Type
                SUPPL
              10. Appl No
                201023
                Application Docs Date
                2020-12-22 00:00:00
                Application Docs ID
                65692
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                24
                Submission Type
                SUPPL
              11. Appl No
                201023
                Application Docs Date
                2021-02-19 00:00:00
                Application Docs ID
                66303
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                25
                Submission Type
                SUPPL
              12. Appl No
                201023
                Application Docs Date
                2023-07-11 00:00:00
                Application Docs ID
                74720
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                26
                Submission Type
                SUPPL
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                201023
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                STANDARD
                Submission Class Code ID
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                AP
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                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                201023
                Review Priority
                STANDARD
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                Submission No
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                Submissions Public Notes
              3. Appl No
                201023
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                PRIORITY
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                Submission No
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                Submission Status
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                Submission Status Date
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                Submissions Public Notes
              4. Appl No
                201023
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                23
                Submission Status
                AP
                Submission Status Date
                2020-03-05 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                201023
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                21
                Submission Status
                AP
                Submission Status Date
                2018-01-09 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                201023
                Review Priority
                PRIORITY
                Submission Class Code ID
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                Submission No
                20
                Submission Status
                AP
                Submission Status Date
                2017-05-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                201023
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                19
                Submission Status
                AP
                Submission Status Date
                2017-09-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                201023
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                17
                Submission Status
                AP
                Submission Status Date
                2016-09-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                201023
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                16
                Submission Status
                AP
                Submission Status Date
                2016-05-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                201023
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                15
                Submission Status
                AP
                Submission Status Date
                2015-06-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                201023
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                14
                Submission Status
                AP
                Submission Status Date
                2015-06-11 00:00:00
                Submission Type
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                Submissions Public Notes
              12. Appl No
                201023
                Review Priority
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                Submission Class Code ID
                4
                Submission No
                13
                Submission Status
                AP
                Submission Status Date
                2015-01-05 00:00:00
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                Submissions Public Notes
              application number
              NDA201023
              approval interpretation
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              current indication status
              not_reconciled
              has approved submission record
              true
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              latest posted label documents
              1. Appl No
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                Application Docs Date
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                Application Docs ID
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                Application Docs Title
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              official application record
              Appl No
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              Appl Public Notes
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              Sponsor Name
              SANOFI AVENTIS US
              openfda application present
              true
              products
              1. Active Ingredient
                CABAZITAXEL
                Appl No
                201023
                Drug Name
                JEVTANA KIT
                Form
                SOLUTION;INTRAVENOUS
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                60MG/1.5ML (40MG/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
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            brand names
            1. Jevtana
            classification reasons
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            exact text
            1 INDICATIONS AND USAGE JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containi
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                TANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 )
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                          Preserved source evidence · Not medical advice