HEPZATO KIT™ Risk Evaluation and Mitigation Strategy (REMS)

What Is the HEPZATO KIT^TM REMS?

A risk evaluation and mitigation strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the US Food and Drug Administration (FDA).

The FDA has determined that a REMS is necessary to ensure that the benefits of HEPZATO KIT outweigh the risks of severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events associated with HEPZATO KIT.

Healthcare Settings must be certified in the HEPZATO KIT REMS in order to dispense HEPZATO KIT.

Healthcare Setting Certification

Please see the HEPZATO KIT prescribing information for more information, including complete boxed warning.

Indication

HEPZATO 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 tissue or lungs that is amenable to resection or radiation.

Resources for Healthcare Professionals

Program Overview

Didactic Modules

Healthcare Setting Enrollment Form

HEPZATO KIT Order Request Form

Procedure Team Qualification Status Form

Criteria for Procedural Competency Checklist

Percutaneous Hepatic Perfusion (PHP) Procedure Outcome Form

Severe Peri-Procedure-related Complications Adverse Events Documentation Form

Download All Resources

Reporting Adverse Events

Reporting of suspected adverse events after administration of HEPZATO KIT is vital for the continued monitoring of the risk/benefit balance of therapy.

To report serious peri-procedural adverse events* including hemorrhage, hepatocellular injury, and thromboembolic events use the Severe Peri-Procedure-related Complications Adverse Events Documentation Form.

Send to Delcath Systems, Inc. via e-mail at
coordinator@HEPZATOKITREMS.com.

To report any other serious adverse events,* contact Delcath at
1-833-632-0458 or FDA at
1-800-FDA-1088 or
www.fda.gov/medwatch.

*Serious adverse events are defined as any adverse experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Have Questions?

For more information on the HEPZATO KIT REMS, call 1-833-632-0457.

Healthcare Setting Locator

Find a certified healthcare setting near you

HEPZATO KIT REMS Portal

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