Patient Handout: Lifileucel

What is Lifileucel?

Lifileucel is an immunotherapy medication used to treat advanced melanoma. It is a type of cell therapy designed to help your immune system recognize and attack cancer cells. Lifileucel is made by modifying your own white blood cells (called T cells) to improve their ability to fight cancer. These modified T cells are then reinfused into your body to target and destroy melanoma cells.

Lifileucel is a form of autologous T cell therapy, which means it is made from your own cells, and it is specifically used for individuals whose melanoma has not responded to other treatments or has returned after other therapies.

How Does Lifileucel Work?

Lifileucel works by using T cells, a type of white blood cell that is naturally involved in fighting infections and cancer. The process involves:

1. Collection of T cells: A sample of your T cells is collected from your blood through a procedure called leukapheresis.
2. Modification in the laboratory: Your T cells are then modified outside your body in the laboratory. The modification improves the T cells’ ability to recognize and attack melanoma cells.
3. Reinfusion: The modified T cells are infused back into your body, where they will go to work attacking and destroying the melanoma cells.

How is Lifileucel Given?

Lifileucel is given through an intravenous (IV) infusion, which means the medication is slowly given directly into a vein. You will receive the infusion at a healthcare facility.

• Preparation: The T cells used for Lifileucel treatment are collected from your own body before the treatment starts. This requires a procedure called leukapheresis, which takes several hours.
• Treatment cycle: After your T cells are collected and modified, they are frozen and stored. When the cells are ready, you will receive an infusion of your modified T cells. The exact number of treatments you will need depends on your individual situation and the response to the therapy.
• Monitoring: You will be closely monitored during and after each infusion for any reactions or side effects.

Possible Side Effects

While Lifileucel can be very effective in treating melanoma, it may cause side effects. Some side effects are more common and mild, while others can be more serious. It is important to be aware of them:

• Common side effects:
  • Fatigue (feeling very tired)
  • Fever
  • Redness, swelling, or pain at the infusion site
  • Chills
  • Nausea
  • Flu-like symptoms
• Serious side effects (seek medical help immediately if you experience any of these):
  • Cytokine release syndrome (CRS): A condition where the body releases large amounts of chemicals (cytokines) into the bloodstream, which can lead to symptoms such as high fever, fatigue, nausea, low blood pressure, difficulty breathing, and organ issues.
  • Neurological toxicity: This can include confusion, seizures, or difficulty speaking or understanding speech. If you experience these symptoms, seek medical attention immediately.
  • Infections: Lifileucel can make your immune system more active, which may increase the risk of infections.
  • Severe allergic reactions: Swelling of the face, lips, tongue, or throat, or trouble breathing.

Precautions

Before starting treatment with Lifileucel, tell your doctor if you have any of the following:

• Autoimmune diseases: If you have an autoimmune disorder (such as rheumatoid arthritis or lupus), your doctor will need to evaluate the potential risks and benefits of Lifileucel for you.
• Infections: Inform your doctor if you have any current infections or a history of infections, as this may affect your eligibility for treatment.
• Pregnancy or breastfeeding: Lifileucel has not been tested in pregnant or breastfeeding women. It is not recommended during pregnancy, and you should not breastfeed while undergoing treatment.
• Medications: Let your doctor know about all the medications you are currently taking, including over-the-counter drugs and supplements. Certain medications may affect your response to Lifileucel.

What to Expect During Treatment

• Leukapheresis procedure: Before you can receive Lifileucel, you will need to undergo a leukapheresis procedure, in which blood is drawn from your body, the T cells are separated and collected, and the remaining blood components are returned to you. This procedure takes several hours.
• Infusion process: After your T cells are modified and prepared, they will be infused back into your body through an IV. The infusion may take an hour or longer.
• Monitoring during infusion: You will be closely monitored during and after the infusion for any signs of side effects, such as fever, chills, or allergic reactions.

What to Do in Case of an Emergency

If you experience any of the following serious symptoms after your Lifileucel infusion, seek emergency medical attention immediately:

• Difficulty breathing
• Chest pain or tightness
• Severe dizziness or confusion
• Seizures
• Swelling of the face, lips, or throat
• Unusual bruising or bleeding
• Severe headache or vision changes

Pregnancy and Breastfeeding

• Pregnancy: It is not known whether Lifileucel can harm an unborn baby. If you are pregnant or planning to become pregnant, you should inform your doctor before starting treatment. Effective birth control should be used during treatment and for a period after treatment.
• Breastfeeding: It is not known whether Lifileucel passes into breast milk. It is recommended that you avoid breastfeeding during treatment with Lifileucel.

Lifestyle Tips

• Stay hydrated: Drink plenty of fluids before, during, and after your treatment to help with side effects like nausea and fatigue.
• Monitor for infections: Lifileucel can make your immune system more active, so it’s important to monitor for any signs of infection such as fever, chills, or new coughs.
• Rest: You may feel tired after your treatment. Make sure to rest as needed and take care of your health during recovery.
• Follow-up appointments: It is essential to attend all scheduled follow-up appointments with your healthcare provider to monitor your progress and manage any side effects.

Conclusion

Lifileucel is a promising treatment for advanced melanoma, particularly for patients who have not responded to other treatments. While it can be highly effective, it is important to be aware of the potential side effects and risks. Always follow the instructions provided by your healthcare team, and don’t hesitate to reach out to them with any concerns during your treatment.

Disclaimer: This handout is for educational purposes only and is not intended as medical advice. Always consult your healthcare provider for specific medical guidance regarding your treatment.