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For adults with metastatic uveal melanoma that has spread to the liver…
You’re covered
each step of the way.
HEPZATO KIT provides direct delivery of chemotherapy to your liver and ongoing support at each step. Keep moving forward… ask your doctor if HEPZATO KIT is right for you.
For adults with metastatic uveal melanoma that has spread to the liver…
You’re covered
each step of the way.
HEPZATO KIT provides direct delivery of chemotherapy to your liver and ongoing support at each step. Keep moving forward… ask your doctor if HEPZATO KIT is right for you.
Indication
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, 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.
Metastatic uveal melanoma and your liver
- For patients with uveal melanoma (a type of eye cancer), there’s about a 50% chance that it will spread to other areas. This is called metastatic uveal melanoma
- In metastatic uveal melanoma, the liver is the most common location for metastases and, if left untreated, liver tumors may grow and lead to liver failure
90% of patients with metastatic uveal melanoma tumors will develop tumors in the liver
What is HEPZATO KIT?
HEPZATO KIT, the first FDA-approved liver-directed therapy, is a drug-device combination that uses a special blood-filtering system to deliver chemotherapy directly to your whole liver. This may reduce the amount of chemotherapy reaching other parts of your body.
HEPZATO KIT might be right for you
To be eligible, you must meet all of these conditions:
Be an adult with uveal melanoma that has spread to your liver and the tumor(s) cannot be
surgically removed
Have liver metastases in less than 50% of your liver and the cancer has not spread to the rest of your body OR
Have uveal melanoma that has spread to bone, lymph nodes, skin, or the lungs, and these other tumors can be surgically removed or treated with radiation
How does HEPZATO KIT work?
HEPZATO KIT uses a unique, 3-step system to deliver high-dose melphalan (a type of chemotherapy) to the tumors in your liver.
Your liver’s blood supply is temporarily isolated from your body’s blood supply using several small plastic tubes (also known as catheters). This “isolation” step is important because your liver will receive high-dose chemotherapy.
Once isolated, HEPZATO KIT delivers melphalan (HEPZATO) to your liver. This high-dose chemotherapy is delivered to your liver tumors (detectable and undetectable) for about 30 minutes.
Once treatment is finished, the separated blood supply in your liver will be filtered for about 30 minutes, to remove more than 80%* of the melphalan (HEPZATO) before the blood is returned to your body.
*Mean (standard deviation) filter efficiency 82.7% (14.4%) for the total filtration period.
Watch the video to discover how HEPZATO KIT works to deliver treatment directly to your whole liver.
How is HEPZATO KIT administered?
HEPZATO KIT is administered by an extensively trained HEPZATO KIT procedural team, which includes:
Interventional radiologist
As procedure team leader, is responsible for image-guided catheter insertion (using minimally invasive small incisions to help reduce your recovery time) to isolate the liver blood supply and deliver the chemotherapy.
Perfusionist
Establishes, monitors, and controls the liver blood supply (using medical pumps) to be sure melphalan is properly introduced, circulated, and filtered before being put back into your body.
Anesthesiologist
Manages and monitors your sedation, breathing, and heart function during the procedure.
Additional healthcare professionals such as oncologists, pharmacists, chemotherapists, and intensivists may support your procedural team.
Why HEPZATO KIT?
The use of HEPZATO KIT was studied in the FOCUS trial, a phase 3 clinical study that treated 91 patients with metastatic uveal melanoma
With HEPZATO KIT treatment, on average, 1 out of 3 patients (33) experienced a response to treatment
- 7.7% of patients had a complete response, meaning that their tumors reduced in size and could be removed by surgery or disappeared completely
- 28.6% of patients had a partial response, meaning that their target tumors reduced in size by 30% or more
- 70% of patients had a response that lasted 6 months or longer
- 30% of patients had a response that lasted 12 months or longer
*A response is a sum of partial response and complete response. Partial response is defined as a reduction in size of target tumors by 30% or more and complete response is defined as complete disappearance of all target tumors.
What are the potential side effects of HEPZATO KIT?
What are the potential side effects of
HEPZATO KIT?
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, vomiting, high liver enzymes, longer blood clotting time, and shortness of breath.
You can find a full list of potential side effects in the Full Prescribing Information.
It is important to notify your oncologist immediately if you experience any of the following side effects:
Fever, bruising, signs of bleeding
Skin rashes, hives, itchiness
Shortness of breath, coughing, increased heart rate, dizziness
Other symptoms to report to your oncologist may include
— Nausea, vomiting, diarrhea
— Muscle pain, stomach pain
— Feeling more tired than usual
Resources
Introducing HEPZATO KIT Access 360!
Our patient assistance program helps with your copay and provides a caring clinical navigator to make treatment with
HEPZATO KIT more affordable and accessible to you. Our goal is to remove any barriers to your care and ensure you receive the best care possible. Your well-being is our top priority, and we’re here to help every step of the way.
The Patient’s Guide to HEPZATO KIT helps you better understand this first FDA-approved liver-directed treatment for patients with metastatic uveal melanoma
Learn more about what happens before, during, and after the HEPZATO KIT procedure
(NOTE: necessary tests and timelines may vary based on hospital guidelines, your doctor’s recommendations, and your individual needs)
You may have many questions about treatment options. See a list of questions commonly asked about HEPZATO KIT that might be useful to discuss with your oncologist
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