Lifileucel (lif-i-LOO-sel)

Treats melanoma (skin cancer).

Brand Name(s):

Amtagvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the IV will need to stay in place for about 1 ½ hours.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may be given other medicines (including cyclophosphamide, fludarabine, allergy medicine, or fever medicine) days or hours before starting treatment with this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how lifileucel works. Tell your doctor if you are using a blood thinner.
• Tell your doctor if you have received a vaccine in the past 28 days or plan to have one.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or if you have kidney disease, liver disease, heart disease, lung problems, low blood pressure, a recent or active infection (including hepatitis B or C), or HIV infection.
• This medicine may cause the following problems:
  • Bleeding problems
  • Serious infections
  • Heart problems
  • Lung problems
  • Kidney problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful or difficult urination
• Chest pain that may spread to your arms, jaw, back, or neck, nausea, unusual sweating
• Fainting, dizziness, lightheadedness
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Tiredness, trouble breathing, uneven heartbeat
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Hair loss or thinning of the hair

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088