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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.