TECARTUS 0.4 - 2 x 10⁸ CELLS FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Tecartus 0.4 – 2 × 108cell dispersion for infusion

autologous anti-CD19 CD3+ cells (viable CAR+ T cells)

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• Your doctor will give you a patient information card. Read it carefully and follow the instructions.
• Always show the patient information card to the doctor or nurse who treats you or if you go to hospital.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tecartus and what is it used for
2. What you need to know before you are given Tecartus

1. How Tecartus is given
2. Possible side effects

1. Storage of Tecartus
2. Contents of the pack and other information

1. What is Tecartus and what is it used for

Tecartus is a gene therapy medicine used to treat mantle cell lymphoma in adults. It is used when other medicines are no longer effective for your treatment (refractory or relapsed mantle cell lymphoma). This medicine is prepared specifically for you from your own modified white blood cells, known as autologous anti-CD19 CD3+ cells.

Mantle cell lymphoma is a cancer that affects part of the immune system (the body's defences). This cancer affects a type of white blood cell called B lymphocytes. In mantle cell lymphoma, B lymphocytes grow out of control and accumulate in the lymph tissue, bone marrow or blood.

How Tecartus works

Your white blood cells are taken from your blood and genetically modified so that they can target the cancer cells in your body. When you are given the Tecartus infusion in your blood, the modified white blood cells will destroy the cancer cells.

2. What you need to know before you are given Tecartus

Tecartus will not be given to you

• if you are allergic to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.
• if you cannot receive the medicine to reduce the number of white blood cells in your blood (lymphodepletion chemotherapy) (see also section 3, ‘How Tecartus is given’).

Warnings and precautions

Tecartus is prepared from your own white blood cells and should only be given to you (autologous use).

Tests and checks

Before you are given Tecartus, your doctor will:

• check your lungs, heart and kidneys and check your blood pressure.
• look for signs of infection or inflammation and decide if you need treatment before you are given Tecartus.
• check if your cancer is getting worse.
• look for signs of graft-versus-host disease that can occur after a transplant. This happens when the transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.

• check your uric acid and the number of cancer cells in your blood. This will show if you are likely to develop a complication called tumour lysis syndrome. You may be given medicines to help prevent this complication.

• check if you have hepatitis B, hepatitis C or HIV infection.
• check if you have been vaccinated in the last 6 weeks or if you are planned to receive a vaccine in the coming months.
• check if you have previously received treatment that targets the protein called CD19.

Sometimes, it may not be possible to give the planned treatment with Tecartus. If the infusion of Tecartus is delayed for more than 2 weeks after you received lymphodepletion chemotherapy, you may need to receive more chemotherapy (see also section 3, ‘How Tecartus is given’).

After you are given Tecartus

If you notice any of the following symptoms, tell your doctor or nurse immediately or seek urgent medical attention:

• chills, extreme tiredness, weakness, dizziness, headache, cough, difficulty breathing, fast or irregular heart rate, severe nausea, vomiting or diarrhoea; these can be symptoms of a complication called cytokine release syndrome. Take your temperature twice a day for 3 to 4 weeks after treatment with Tecartus. If your temperature is high, contact your doctor immediately.

• seizures, tremors or difficulty speaking or slurred speech, loss of consciousness or decreased level of consciousness, confusion and disorientation, loss of balance or coordination.

• fever (e.g. temperature over 38 °C), which can be a sign of infection.

• extreme tiredness, weakness and difficulty breathing, which can be symptoms of low red blood cell counts.
• bleeding or bruising easily, which can be symptoms of low platelet counts.

If any of the above applies to you (or you are not sure), talk to your doctor or nurse.

Your doctor will check your blood counts frequently as the number of blood cells and other components of the blood may decrease.

You will be asked to register in a registry for at least 15 years to better understand the long-term effects of Tecartus.

Do not donate blood, organs, tissues or cells for transplants.

Children and adolescents

Tecartus should not be given to children and adolescents under 18 years of age.

Other medicines and Tecartus

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Before you are given Tecartus, tell your doctor or nurse if you are taking any medicine that weakens the immune system, such as corticosteroids, as these medicines may interfere with the effect of Tecartus.

You should not be given certain vaccines called live vaccines, in particular:

• in the 6 weeks before you receive the short course of lymphodepletion chemotherapy to prepare your body for the Tecartus cells.
• during treatment with Tecartus.

• after treatment while your immune system is recovering.

Ask your doctor if you need any vaccine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. This is because the effects of Tecartus on pregnant or breast-feeding women are not known, and it may harm the unborn child or baby.

• a pregnancy test will be performed before you start treatment. Tecartus should only be given if the results show you are not pregnant.

Talk to your doctor about pregnancy if you received Tecartus.

Driving and using machines

Tecartus may cause problems such as altered consciousness or decreased consciousness, confusion and seizures (convulsions) in the 8 weeks after administration.

Do not drive, do not use machines or engage in activities that require heavy concentration for at least 8 weeks after treatment with Tecartus or until your doctor confirms that you have fully recovered.

Tecartus contains sodium, dimethyl sulfoxide (DMSO) and gentamicin

This medicine contains 300 mg of sodium (main component of cooking/table salt) in each infusion. This is equivalent to 15 % of the maximum recommended daily intake of sodium for an adult. It also contains DMSO and gentamicin, which may cause severe hypersensitivity reactions.

3. How Tecartus is given

Tecartus will always be given to you by a healthcare professional.

• since Tecartus is prepared from your own white blood cells, your cells will be collected to prepare your medicine. Your doctor will take some of your blood with a catheter placed in a vein (a procedure called leukaapheresis). Some white blood cells will be separated from the blood and the rest of the blood will be returned to the vein. This may take 3 to 6 hours and may need to be repeated.

• your white blood cells will be sent to a manufacturing site to make Tecartus. It usually takes 2 to 3 weeks to make Tecartus, but the time may vary.

Medicines given before treatment with Tecartus

a few days before you receive Tecartus, you will be given lymphodepletion chemotherapy, which will allow the modified white blood cells in Tecartus to multiply in your body once you are given the medicine.

during the 30 to 60 minutes before you are given Tecartus, you may be given other medicines. This is to help prevent infusion reactions and fever. These other medicines may include:

• paracetamol.

• an antihistamine such as diphenhydramine.

How Tecartus is given

Tecartus will always be given to you by a doctor in a qualified medical centre.

• Tecartus is given as a single dose.
• your doctor or nurse will give you a single infusion of Tecartus through a catheter placed in a vein (intravenous infusion) over about 30 minutes.
• Tecartus is your modified white blood cells. The healthcare professional handling the treatment will therefore take necessary precautions (wear gloves and goggles) to avoid possible transmission of infectious diseases and will follow local guidelines for the treatment of human origin waste for cleaning and disposal of any material that has come into contact with the treatment.

After you are given Tecartus

• you should stay near the hospital where you were treated for at least 4 weeks after treatment with Tecartus. Your doctor will recommend that you return to the hospital daily for at least 10 days or that you stay in hospital for the first 10 days after treatment with Tecartus. This is so that your doctor can check if your treatment is working and help you if you have any side effects.