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LABELS · 6a6d50c7-06ea-479c-83cc-f197a9e428c9

MARGENZA

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
2025-02-11
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.2 , 5.1 , 6.1 ) Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ]. Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1 , 8.3) ].

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 )
Full extracted label fields
application numbers
  1. BLA761150
boxed warning exact
  1. WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.2 , 5.1 , 6.1 ) Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ]. Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1 , 8.3) ].
brand names
  1. MARGENZA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a6d50c7-06ea-479c-83cc-f197a9e428c9
generic names
  1. MARGETUXIMAB-CMKB
id
6a6d50c7-06ea-479c-83cc-f197a9e428c9
indications and usage exact
  1. 1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. TerSera Therapeutics LLC
    matched search terms
    1. cancer
    package ndcs
    1. 70720-022-01
    2. 70720-022-02
    3. 70720-022-03
    product ndcs
    1. 70720-022
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRAVENOUS
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      1. 2474028
      2. 2474033
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      spl effective date
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      spl effective time
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      substance names
      1. MARGETUXIMAB
      uniis
      1. K911R84KEW
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      Drugs@FDA application source records
      1. application number
        BLA761150
        payload
        all indexed label documents
        1. Appl No
          761150
          Application Docs Date
          2020-12-17 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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        2. 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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          Submission No
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        all submission records
        1. Appl No
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          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2025-01-15 00:00:00
          Submission Type
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          Submissions Public Notes
        2. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission Status Date
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          Submissions Public Notes
        3. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        application number
        BLA761150
        approval interpretation
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        current indication status
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        has approved submission record
        true
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        2025-01-15
        latest label selection rule
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        latest posted label documents
        1. Appl No
          761150
          Application Docs Date
          2023-05-26 00:00:00
          Application Docs ID
          74384
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        MACROGENICS INC
        openfda application present
        true
        products
        1. Active Ingredient
          MARGETUXIMAB-CMKB
          Appl No
          761150
          Drug Name
          MARGENZA
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          2
          Reference Standard
          0
          Strength
          250MG/10ML(25MG/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. MARGENZA
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      true
      exact text
      1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more p
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      3. context exact
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      4. context exact
        ore prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ].
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      5. context exact
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      6. context exact
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      7. context exact
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      8. context exact
        1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Admi
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          1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ].
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          ER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 )
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            MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adu
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          3. context exact
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          4. context exact
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                    Preserved source evidence · Not medical advice