Personalized Support for HEPZATO KIT™
HEPZATO KIT™ Access is a personalized support program offered to patients, providers, and facilities while navigating the payor authorization process. Our dedicated reimbursement experts will provide status updates while coverage and product access details are finalized.
Patient Support
Complete HIPAA & enrollment forms
Service Provider Support
Access HIPAA & enrollment forms
WHAT IS HEPZATO AND HEPZATO KIT?
HEPZATO( melphalan) is a prescription drug for liver directed treatment for adults with uveal melanoma (a certain type of eye cancer) that has spread to the liver but can’t be removed with surgery. This treatment is for cases where less than half of the liver is affected, and the cancer hasn’t spread to other parts of the body, or it has only spread to the bones, lymph nodes, skin, or lungs where it can be treated with surgery or radiation.
HEPZATO KIT uses a special delivery system to send the medicine HEPZATO (melphalan) directly to the liver artery and a filtration system to reduce the amount of melphalan in the blood before it goes back into the rest of the body.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about HEPZATO?
- HEPZATO may cause serious problems like bleeding, liver damage, and blood clots. You may need to stop taking blood thinners or blood pressure medicine before treatment with HEPZATO KIT.
- HEPZATO can only be used through a special program called the HEPZATO KIT REMS (Risk Evaluation and Mitigation Strategies) Program.
- HEPZATO can lower the number of blood cells, leading to serious infections, bleeding, or anemia. Tell your doctor right away if you have a fever, bruising, or bleeding.
Do not take HEPZATO if you have:
- active brain cancer or brain spots that are likely to bleed
- liver failure, high blood pressure in the liver, or known risk of bleeding in the liver
- surgery or medical treatment of the liver in the past 4 weeks
- blood clotting problems that can’t be fixed
- inability to safely undergo general anesthesia, including heart problems like unstable or severe chest pain, heart attack, worsening or new heart failure, serious irregular heartbeats, or severe heart valve disease
- history of allergies or known reactions to melphalan or any part of the HEPZATO KIT, including natural rubber latex, heparin, or severe reactions to iodine contrast not controlled by antihistamines and steroids
HEPZATO may cause serious side effects including:
Secondary malignancies, HEPZATO could have a long-term risk of causing another type of cancer.
HEPZATO can cause serious birth defects if taken during pregnancy. Females who can become pregnant should use effective birth control during treatment with HEPZATO and for 6 months after the last dose. Contact your doctor if you become pregnant or think you might be pregnant while taking HEPZATO. Males with partners who can become pregnant should use effective birth control during treatment with HEPZATO and for 3 months after the last dose.
Infertility, HEPZATO has been reported to cause infertility in females and males.
Do not breastfeed during treatment with HEPZATO and for one week after the last dose.
The most common side effects of HEPZATO are: low platelets, tiredness, low red blood cells, nausea, muscle and bone pain, low white blood cells, belly pain, low white blood cells, vomiting, high liver enzymes, longer blood clotting time, and shortness of breath.
Please see full Prescribing Information, including Boxed Warning.
Call your healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Delcath at 1-833-632-0458 and www.Delcath.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Patient Support
Complete HIPAA & Enrollment Forms
Service Provider Support
Access HIPAA & Enrollment Forms
Expedited access
We aim to minimize the administrative complexities of obtaining prior authorizations and ensure efficient access to the HEPZATO KIT™ for eligible patients, through streamlined processes and dedicated resources.
Procurement & reimbursement
We assist facilities with navigating procurement processes, charge entry, and reimbursement-related support.
Collaborative partnership
As part of the Patient Access Program, Delcath’s dedicated team of experts will collaborate closely with your center to address any queries and provide ongoing support to ensure a smooth patient and provider experience.