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LABELS · 5c711945-70be-42f4-b153-e1459dd9929c

KYXATA

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
2025-09-02
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. ( 5.1 ) Immediately withhold KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. 1.2 Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.
Full extracted label fields
application numbers
  1. NDA219921
boxed warning exact
  1. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. ( 5.1 ) Immediately withhold KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction. ( 5.1 )
brand names
  1. KYXATA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f91c48da-68d1-4aa7-89b8-d84a3e8b629b
generic names
  1. CARBOPLATIN
id
5c711945-70be-42f4-b153-e1459dd9929c
indications and usage exact
  1. 1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. 1.2 Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Avyxa Pharma, LLC
    matched search terms
    1. carcinoma
    package ndcs
    1. 83831-140-02
    2. 83831-141-08
    3. 83831-142-50
    product ndcs
    1. 83831-141
    2. 83831-140
    3. 83831-142
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRAVENOUS
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      1. 597195
      2. 2721602
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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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        payload
        all indexed label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
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          Submission No
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          Submission Status Date
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          Submissions Public Notes
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        latest posted label documents
        1. Appl No
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          Application Docs ID
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          Application Docs Title
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        Appl No
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        Sponsor Name
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        openfda application present
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        products
        1. Active Ingredient
          CARBOPLATIN
          Appl No
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          Drug Name
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          Form
          SOLUTION;INTRAVENOUS
          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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          marketing status
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        2. Active Ingredient
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          Appl No
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          Drug Name
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          Form
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          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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          marketing status
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        3. Active Ingredient
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          Appl No
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          Drug Name
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          Form
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          Product No
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          Reference Drug
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          Reference Standard
          1
          Strength
          500MG/50ML (10MG/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
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      1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regim
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          1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma.
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          1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is i
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                1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. 1.2 Recurrent A
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                              1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma.
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                              r chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. 1.2 Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.
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                                  1.2 Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.
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                                  Preserved source evidence · Not medical advice