Hepzato 50 mg intra-arterial solution

Generic name:
Melphalan - intra-arterial

Pronunciation
(MEL-fa-lan)

Brand name(s)
Hepzato

This medication is part of a kit that also includes a Hepatic Delivery System (HDS). Melphalan is directly given to the artery in the liver (hepatic intra-arterial) using the HDS through a medical procedure. Melphalan and the procedure can cause serious (rarely fatal) side effects such as bleeding, blood clots, damage to the liver cells, or low blood pressure. You may be at an increased risk if you have a history of liver problems or liver surgery.

To reduce your risk, your doctor may start other medications (such as heparin) or stop medications you are currently taking (such as blood pressure medications) before your procedure. Your doctor may also monitor you during and for 72 hours after the procedure.

This medication may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection or any infection you have may get worse. Tell your doctor right away if you develop signs of infection (such as a sore throat that doesn't go away, fever, chills), easy or unusual bruising/bleeding, or unusual tiredness.

This medication is used to treat serious liver problems (liver metastases) that may occur with some types of skin cancer. Melphalan belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

See also Warning section.

Read the Patient Information Leaflet if available from your pharmacist before you start using melphalan and each time you receive this medication. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional using the Hepatic Delivery System (HDS), usually every 6 to 8 weeks. HDS uses a closed system of catheters to deliver melphalan directly to the artery in the liver.

The dosage is based on your medical condition, weight, lab tests, and response to treatment.

See also Warning section.

Nausea, vomiting, diarrhea, stomach pain, muscle pain, dizziness, headache, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Although melphalan is used to treat cancer, it may rarely increase your risk of developing other cancers. Tell your doctor right away if you develop unusual growths or lumps, or swollen glands.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• fast heartbeat
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before receiving melphalan (as part of the kit), tell your doctor or pharmacist if you are allergic to it; or to chlorambucil; or to contrast media; or if you have any other allergies. This product may contain inactive ingredients (such as latex in the kit), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood problems
• cancer that has spread to the brain (metastases)
• liver problems (such as liver failure)
• liver surgery/treatment especially in the past 4 weeks
• heart problems (such as heart failure, irregular heartbeat)
• radiation treatment

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Melphalan can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using melphalan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).

This medication can affect fertility in both males and females. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using melphalan. Melphalan may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Melphalan is very similar to melphalan flufenamide. Do not use medications containing melphalan flufenamide while using melphalan.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, liver function) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.