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LABELS · 6351a7fd-3941-4ddb-9c77-fb9225140151

Hepzato Kit

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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
2026-06-09
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of HEPZATO. Assess patients for these adverse reactions during and for at least 72 hours following administration of HEPZATO [see Warnings and Precautions ( 5.1 )]. HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS [see Warnings and Precautions ( 5.2 )]. Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory parameters and delay additional cycles of HEPZATO therapy until blood counts have improved. [see Warnings and Precautions ( 5.1 )] WARNING: SEVERE PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur with intra-hepatic administration of HEPZATO. Assess patients for these adverse reactions during and for 72 hours following administration of HEPZATO. ( 5.1 ) HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS. ( 5.2 ) Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory parameters and delay additional cycles of HEPZATO therapy until blood counts have improved.( 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.( 1 )
Full extracted label fields
application numbers
  1. NDA201848
boxed warning exact
  1. WARNING: PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of HEPZATO. Assess patients for these adverse reactions during and for at least 72 hours following administration of HEPZATO [see Warnings and Precautions ( 5.1 )]. HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS [see Warnings and Precautions ( 5.2 )]. Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory parameters and delay additional cycles of HEPZATO therapy until blood counts have improved. [see Warnings and Precautions ( 5.1 )] WARNING: SEVERE PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur with intra-hepatic administration of HEPZATO. Assess patients for these adverse reactions during and for 72 hours following administration of HEPZATO. ( 5.1 ) HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS. ( 5.2 ) Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory parameters and delay additional cycles of HEPZATO therapy until blood counts have improved.( 5.3 )
brand names
  1. Hepzato Kit
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f83c8f7-4cc0-4219-88d5-7cfddce91198
generic names
  1. MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
id
6351a7fd-3941-4ddb-9c77-fb9225140151
indications and usage exact
  1. 1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Delcath Systems, Inc.
    matched search terms
    1. melanoma
    package ndcs
    1. 75833-601-01
    2. 75833-601-02
    3. 75833-601-07
    4. 75833-601-08
    5. 75833-800-01
    6. 75833-700-01
    7. 75833-444-01
    product ndcs
    1. 75833-601
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRA-ARTERIAL
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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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      spl effective date
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      spl effective time
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          1. application number
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            payload
            all indexed label documents
            1. Appl No
              201848
              Application Docs Date
              2023-08-15 00:00:00
              Application Docs ID
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              Application Docs ID
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              Submission Class Code ID
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            2. Appl No
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            5. Appl No
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              2025-07-30 00:00:00
              Submission Type
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            7. Appl No
              201848
              Review Priority
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              Submission Class Code ID
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              Submission No
              15
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              AP
              Submission Status Date
              2025-09-04 00:00:00
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              Submissions Public Notes
            8. Appl No
              201848
              Review Priority
              STANDARD
              Submission Class Code ID
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              Submission No
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              AP
              Submission Status Date
              2026-05-28 00:00:00
              Submission Type
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            9. Appl No
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              Submission Class Code ID
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              Submission No
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              Submissions Public Notes
            10. Appl No
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              Submissions Public Notes
            application number
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            approval interpretation
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            current indication status
            not_reconciled
            has approved submission record
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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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              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
            201848
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            DELCATH SYSTEMS INC
            openfda application present
            true
            products
            1. Active Ingredient
              MELPHALAN HYDROCHLORIDE
              Appl No
              201848
              Drug Name
              HEPZATO
              Form
              POWDER;INTRA-ARTERIAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              EQ 50MG BASE/VIAL
              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. Hepzato Kit
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          exact text
          1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepa
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              1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
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              es affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.( 1 )
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                  HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.( 1 )
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                  7e664223565a522bc2611c461af36af64cf000055ed4f649eb1e928ee70cea15
                  start
                  398
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%226351a7fd-3941-4ddb-9c77-fb9225140151%22
                  spl effective date
                  2026-06-09
                  spl set id
                  4f83c8f7-4cc0-4219-88d5-7cfddce91198
                  spl version
                  8
                  structured fields status
                  not_extracted_no_values_inferred_from_mentions
                  structured indication
                  age
                  Source null
                  approval pathway
                  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
                  tumor_directed_candidate

                  Preserved source evidence · Not medical advice