Lifileucel is used in adults to treat melanoma (skin cancer) that has spread to other parts of the body or cannot be removed by surgery.

Lifileucel may also be used for purposes not listed in this medication guide.

Tell your doctor if you have or have ever had:

• a recent or an active infection;
• an inflammatory condition including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection;
• if your cancer symptoms are getting worse;
• if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests;
• if you received a vaccine in the past 28 days;
• if you are scheduled to receive a vaccine in the next few months;
• heart problems;
• lung disease;
• low blood pressure; or
• liver or kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

It is not known if lifileucel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Amtagvi (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe infections such as sepsis, pneumonia, encephalitis;
• breathing problems;
• easy bruising or bleeding, unusual weakness;
• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• kidney problems--swelling, urinating less, feeling tired or short of breath; or
• heart problems--irregular heartbeats, swelling, rapid weight gain, feeling short of breath.

Common side effects may include:

• fever, chills;
• mouth sores, rash, skin sores, sore throat, cough;
• pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
• hair loss;
• swelling;
• fast or irregular heartbeats;
• low blood pressure; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.