Lifileucel is used to treat a certain type of skin cancer (melanoma) that has not gotten better or that has come back after other kinds of treatment. Lifileucel is made from your own white blood cells found in your tumor and is given only to you. The white blood cells help your body slow or stop the growth of certain cancer cells.

Read the Patient Information Leaflet if available from your health care professional before you receive lifileucel. If you have any questions, ask your health care professional.

Your doctor will give you 7 days of chemotherapy before treatment with lifileucel to prepare your body. After receiving lifileucel, you will be given another medication to help lifileucel work better.

This product is given by slow injection into a vein as directed by your doctor. Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) before treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as shortness of breath, fever, chills, fast heartbeat, rash, or dizziness.

Your doctor will check you daily after your treatment to see how well it works and help you manage any side effects. You should plan to stay for several weeks near the place of your treatment (for example, within 2 hours' drive).

See also Warning and How to Use sections.

Diarrhea, tiredness, or hair loss may occur. 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.

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as sore throat that doesn't go away, fever, chills, cough)
• easy bruising/bleeding
• pale skin
• unusual tiredness
• signs of kidney problems (such as change in the amount of urine)
• fast/irregular heartbeat
• swelling ankles/feet
• sudden unexplained weight gain

Get medical help right away if you have any very serious side effects, including:

• signs of stomach/intestinal bleeding (such as bloody/black/tarry stools, vomit that looks like coffee grounds)
• signs of bleeding in the brain (such as sudden vision changes, dizziness/fainting, confusion)
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

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
• 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.

Before receiving lifileucel, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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

• heart problems
• kidney problems
• liver problems
• lung problems
• past/current/recent infections

This product 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 lifileucel 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.

This drug may make you dizzy or make it harder for you to think clearly. 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 (at least 3 weeks after receiving treatment is recommended by some manufacturers). Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lifileucel. Lifileucel may harm an unborn baby. Your doctor should order a pregnancy test before you start this product. If you become pregnant, talk to your doctor right away about the risks and benefits of this product.

It is unknown if this product passes into breast milk. 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.

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 counts, heart/lung/kidney function) should be done before and after you receive this product. Keep all medical and lab appointments.

Not applicable.

Not applicable. This product is given in a hospital 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).