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.

How to use Lifileucel 7.5 X 10Exp9 To 72 Cell Intravenous Suspension

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 while you are receiving lifileucel. Tell your doctor or nurse right away if you have any symptoms of infusion reactions such as shortness of breath, fever, chills, fast heartbeat, rash, or dizziness. To decrease the risk of infusion reactions, your doctor may also give you other medications (such as acetaminophen, diphenhydramine) before injecting lifileucel.

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).

Side Effects

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 a 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

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


Lifileucel may cause serious (rarely fatal) problems in the heart, lungs, or kidneys. This product may also cause a severe decrease in your blood cells. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. You may be more likely to get a serious (rarely fatal) infection or have a bleeding problem. To decrease the risk of side effects, your doctor may direct you to use another medication to help your body make more blood cells. You will also be given this product in a hospital so your doctor can watch for serious side effects and quickly provide treatment if needed. See also Side Effects section.


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.

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.

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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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes Notes

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.

Missed Dose Missed Dose

Not applicable.

Storage Storage

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


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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.