Lifileucel Injection

IMPORTANT WARNING:

Lifileucel injection has been associated with treatment-related mortality, prolonged cytopenia (lower than normal cell count), severe infections, and cardiac, pulmonary and renal impairment. Your doctor will have you receive this drug in the hospital where you can be monitored carefully and be given other medications to help prevent some of these effects. Before receiving lifileucel injection, tell your doctor if you have or have had bleeding disorder, low platelets, immunocompromise (high risk of infection), infections including Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), tuberculosis cytomegalovirus (CMV) or any other significant infection, low blood pressure, kidney disease or any cardiac or pulmonary disease. Be sure and let your doctor know if you are taking any blood thinners.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to lifileucel.

Talk to your doctor about the risk(s) of receiving lifileucel.

WHY is this medicine prescribed?

Lifileucel injection is used treat certain types of melanoma (skin cancer) that have either spread to other parts of the body or are unable to be remove surgically and have not responded to other treatments. Lifileucel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lifileucel comes as a suspension (liquid) to be injected into a vein by a doctor or nurse at a hospital. Your dose of lifileucel will be made from cells retrieved from your surgically removed tumor tissue and sent to a manufacturing center. It will take 34 days for your dose of lifileucel to be made and ready to be given to you. Your doctor will give you chemotherapy medications for 2 days about 5 days before you are scheduled to receive lifileucel to help prepare your body for lifileucel therapy. Right before you are given lifileucel, you will be given several medications to help prevent some of the side effects from lifileucel. You will need to stay in the hospital for several days after receiving lifileucel and then should plan to stay in the immediate area of where you received lifileucel for several weeks.

It is important to be on time and not to miss any scheduled appointments for cell collection or to receive lifileucel injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving lifileucel injection,

• tell your doctor and pharmacist if you are allergic to lifileucel, any other medications, or any of the ingredients in lifileucel injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving lifileucel injection.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Women who are capable of getting pregnant should have a pregnancy test before receiving lifileucel.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Lifileucel injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• vomiting
• nausea
• fatigue
• swelling
• weight gain
• decreased appetite
• headache
• loss of hair

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately {or get emergency medical treatment}:

• blood in the urine, difficulty urinating or little urine, pain in the lower back
• unusual bruising or bleeding, nose bleeding, severe headache, blood in urine, stool, or vomit, coughing up blood, or unusual abdominal or back pain
• fever, sore throat, ongoing cough and congestion, or other signs of infection
• hives; rash; itching; swelling of the lips, tongue, or throat; shortness of breath or difficulty breathing
• difficulty breathing or shortness or breath, chest pain, bluish skin
• yellowing of skin or the whites of the eyes, lower abdominal pain, dark urine
• racing heart or feeling like heart is skipping a beat, chest pain, dizziness

Lifileucel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will may order certain lab tests to check your body's response to lifileucel injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving exagamglogene autotemcel injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.