U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. REMS

Approved Risk Evaluation and Mitigation Strategies (REMS)

Hepzato (melphalan)
NDA #201848
REMS last update: 01/22/2024



What is the purpose of the REMS?

The goal of the HEPZATO KIT REMS is to mitigate the risks of severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events associated with HEPZATO KIT.
    Objective: Minimize severe peri-procedural complications

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare settings that dispense HEPZATO KIT must:

To become certified to dispense
  • Have percutaneous hepatic perfusion procedure team(s) that must include healthcare providers with expertise in interventional radiology, anesthesiology, and perfusion as described in the Instructions for Use.
  • Have the following on-site: interventional radiology suite or operating room with fluoroscopy and with resuscitation personnel, equipment, and medications.
  • Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the healthcare setting.
  • Have the Authorized Representative review the product’s Prescribing Information, Instructions for Use, Program Overview, and Didactic Modules.
    | Didactic Modules | | Program Overview |
  • Have the Authorized Representative enroll in the REMS by completing and submitting the Healthcare Setting Enrollment Form to the REMS.
    | Healthcare Setting Enrollment Form |
  • Have the percutaneous hepatic perfusion procedure team members that perform procedures with HEPZATO KIT review the product’s Prescribing Information and Instructions for Use.
  • Have the percutaneous hepatic perfusion procedure team members that perform procedures with HEPZATO KIT take the Program Overview, Didactic Modules, and Preceptorship training provided by Delcath Systems, Inc.
    | Didactic Modules | | Program Overview |
  • Have the percutaneous hepatic perfusion procedure team members that perform procedures with HEPZATO KIT successfully complete the Proctorship training provided by Delcath Systems, Inc., and successfully complete and submit the Criteria for Procedural Competency Checklist to the REMS.
    | Criteria for Procedural Competency Checklist |
  • Establish processes and procedures to ensure relevant new staff who will perform percutaneous hepatic perfusion procedures with HEPZATO KIT are trained.
Before administering
  • Obtain authorization to dispense each HEPZATO KIT by contacting the REMS to verify the percutaneous hepatic perfusion procedure team is qualified using the Procedure Team Qualification Status Form.
    | Procedure Team Qualification Status Form |
During and after administering, for at least 72 hours
To maintain certification to dispense, annually
  • Have percutaneous hepatic perfusion procedure team(s) that must include healthcare providers with expertise in interventional radiology, anesthesiology, and perfusion as described in the Instructions For Use.
  • Have percutaneous hepatic perfusion procedure team members who have each performed one procedure in the first six months following completion of training, a second procedure in the next six months, and at least two procedures annually thereafter.
  • Have the following on-site: interventional radiology suite or operating room with fluoroscopy and with resuscitation personnel, equipment, and medications.
  • If there is a change in Authorized Representative, have a new Authorized Representative enroll in the REMS by completing the Healthcare Setting Enrollment Form.
    | Healthcare Setting Enrollment Form |
At all times
  • Maintain records of each percutaneous hepatic perfusion procedure team member’s training.
  • Maintain records of the percutaneous hepatic perfusion procedures performed with HEPZATO KIT and the associated percutaneous hepatic perfusion procedure team members’ participation.
  • Maintain records that processes and procedures are in place and are being followed.
  • Comply with audits carried out by Delcath Systems, Inc., or a third party acting on behalf of Delcath Systems, Inc., to ensure that all training, processes, and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers.

Material Name Material Name Link
Criteria for Procedural Competency Checklist (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Criteria_for_Procedural_Competency_Checklist.pdf
Didactic Modules (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Didactic_Modules.pdf
Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Healthcare_Setting_Enrollment_Form.pdf
Procedure Team Qualification Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Procedure_Team_Qualification_Status_Form.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Program_Overview.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_REMS_Full.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_REMS_Website.pdf
Severe Peri-Procedure-related Complications Adverse Events Documentation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Hepzato_2024_01_22_Severe_Peri-Procedure_related_Complications_Adverse_Events_Documentation_Form.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
01/22/2024 Modified to update the layout of the REMS materials to align with updated product branding, make minor changes to the graphics, functionality, and navigation of the REMS Website, and make minor modifications to the Didactic Module that upgrades graphic resolution and addresses grammatical, formatting, and typographical errors.
08/14/2023 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

Back to Top