Lifileucel

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 reasons not mentioned in this medication guide.

Lifileucel is available only at an authorized hospital or clinic and must be administered by specially trained healthcare professionals. This medicine is injected into a vein by a healthcare provider.

You may receive other medications to help prevent serious side effects or allergic reactions.

Tell your doctor if you are taking other medicines, have other medical conditions, or have allergies.

You may receive another medication during treatment to help your body produce white blood cells.

Call your doctor immediately if you notice signs of infection, such as: fever, chills, sore throat, mouth sores, red or swollen gums, pale skin, easy bruising, unusual bleeding, or chest discomfort, wheezing, dry cough or hack, rapid weight loss.

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 lifileucel.

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

Lifileucel may cause serious side effects. Call your doctor right away 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 of lifileucel 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.

Usual Adult Dose for Melanoma -- Metastatic:

7.5 x 10(9) to 72 x 10(9) viable cells IV once as a single dose -Infuse an initial rate of 1 mL/min for the first 5 minutes, then at a rate of 5 to 10 mL/min thereafter.Comments:-A single dose of this drug is provided in 1 to 4 patient-specific IV infusion bag(s) containing a suspension of tumor-derived T cells; multiple infusions may be required to deliver a single dose.-Administer under the supervision of a physician experienced in the use of anticancer agents in the inpatient hospital setting with access to an intensive care facility and skilled cardiopulmonary/intensive care specialists. Use: As a tumor-derived autologous T cell immunotherapy for the treatment of unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect lifileucel, especially oral, nasal, inhaled, or injectable steroid medicines.

Other drugs may also affect lifileucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Be sure to inform your doctor about all other medicines you are using.