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LABELS · d8b343ee-5767-4934-ad68-5164d4de5228

ERIVEDGE

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
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: EMBRYO-FETAL TOXICITY ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE [ see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE. ( 2.1 , 5.1 , 8.1 , 8.3 ) Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. ( 5.1 , 8.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ( 1 )
Full extracted label fields
application numbers
  1. NDA203388
boxed warning exact
  1. WARNING: EMBRYO-FETAL TOXICITY ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE [ see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE. ( 2.1 , 5.1 , 8.1 , 8.3 ) Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. ( 5.1 , 8.3 )
brand names
  1. ERIVEDGE
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eb368bb6-80e3-4df9-8a85-91df0a2ada6a
generic names
  1. VISMODEGIB
id
d8b343ee-5767-4934-ad68-5164d4de5228
indications and usage exact
  1. 1 INDICATIONS AND USAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genentech, Inc.
    matched search terms
    1. carcinoma
    package ndcs
    1. 50242-140-01
    2. 50242-140-86
    product ndcs
    1. 50242-140
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration ( 2.3 ) 3/2023 Warnings and Precautions ( 5.3 ) 3/2023
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
    1. 1242992
    2. 1242998
    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
    2024-12-02
    spl effective time
    20241202
    spl set id
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    spl version
    15
    substance names
    1. VISMODEGIB
    uniis
    1. 25X868M3DS
    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
      NDA203388
      payload
      all indexed label documents
      1. Appl No
        203388
        Application Docs Date
        2012-01-30 00:00:00
        Application Docs ID
        19461
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        203388
        Application Docs Date
        2015-05-27 00:00:00
        Application Docs ID
        19462
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
        SUPPL
      3. Appl No
        203388
        Application Docs Date
        2015-05-27 00:00:00
        Application Docs ID
        19463
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      4. Appl No
        203388
        Application Docs Date
        2015-05-27 00:00:00
        Application Docs ID
        40290
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        6
        Submission Type
        SUPPL
      5. Appl No
        203388
        Application Docs Date
        2015-05-27 00:00:00
        Application Docs ID
        40291
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        8
        Submission Type
        SUPPL
      6. Appl No
        203388
        Application Docs Date
        2016-11-04 00:00:00
        Application Docs ID
        45809
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      7. Appl No
        203388
        Application Docs Date
        2017-08-04 00:00:00
        Application Docs ID
        49235
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      8. Appl No
        203388
        Application Docs Date
        2019-01-22 00:00:00
        Application Docs ID
        57283
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      9. Appl No
        203388
        Application Docs Date
        2019-03-27 00:00:00
        Application Docs ID
        58082
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      10. Appl No
        203388
        Application Docs Date
        2020-08-03 00:00:00
        Application Docs ID
        64188
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      11. Appl No
        203388
        Application Docs Date
        2023-03-28 00:00:00
        Application Docs ID
        73897
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        17
        Submission Status
        AP
        Submission Status Date
        2023-03-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2020-07-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2019-03-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2019-01-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2017-08-01 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2016-11-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2015-05-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2015-05-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2015-05-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        203388
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2015-05-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        203388
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2014-10-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        203388
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2013-12-19 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA203388
      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
      2023-03-27
      latest label selection rule
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      latest posted label documents
      1. Appl No
        203388
        Application Docs Date
        2023-03-28 00:00:00
        Application Docs ID
        73897
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      official application record
      Appl No
      203388
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      GENENTECH
      openfda application present
      true
      products
      1. Active Ingredient
        VISMODEGIB
        Appl No
        203388
        Drug Name
        ERIVEDGE
        Form
        CAPSULE;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        150MG
        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. NDA203388
    brand names
    1. ERIVEDGE
    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
    473
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred fol
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    duplicate text group
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    generic names
    1. VISMODEGIB
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    label id
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    positive predicate support span
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    qualifier mentions
    1. context exact
      ATIONS AND USAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advan
      kind
      age
      polarity
      not_inferred
      span
      end
      73
      end exclusive
      true
      exact text
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    2. context exact
      SAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has rec
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      biomarker
      polarity
      not_inferred
      span
      end
      110
      end exclusive
      true
      exact text
      metastatic basal cell carcinoma
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    3. context exact
      SAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has rec
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      polarity
      not_inferred
      span
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      end exclusive
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      metastatic basal cell carcinoma
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    4. context exact
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      kind
      stage_or_setting
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      not_inferred
      span
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      locally advanced basal cell carcinoma that has recu
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    regulatory links
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      source defined aliases
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        exact text
        1 INDICATIONS AND USAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.
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        source url
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        spl effective date
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        spl set id
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        structured fields status
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        Source null
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        Source null
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        Source null
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        Passage 2 · positive indication candidate
        application numbers
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        exact text
        with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ( 1 )
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        end exclusive
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        is a hedgehog pathway inhibitor indicated
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        qualifier mentions
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                  Preserved source evidence · Not medical advice