Tecartus (Great Britain)

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it.
• Always show the Patient Alert Card to the doctor or nurse when you see them 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.

1. What Tecartus is and what it is used for
2. What you need to know before you are given Tecartus
3. How Tecartus is given
4. Possible side effects
5. How to store Tecartus
6. Contents of the pack and other information

The white blood cells are taken from your blood and are genetically modified so that they can target the cancer cells in your body. When Tecartus is infused into your blood, the modified white blood cells will kill the cancer cells.

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

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

Before you are given Tecartus your doctor will:

• Check your lungs, heart, kidney and blood pressure.
• Look for signs of infection or inflammation; and decide whether you need to be treated before you are given Tecartus.
• Check if your cancer is getting worse.
• Look for signs of graft-versus-host disease that can happen after a transplant. This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.
• Check your blood for uric acid and for how many cancer cells there are in your blood. This will show if you are likely to develop a condition called tumour lysis syndrome. You may be given medicines to help prevent the condition.
• Check for hepatitis B, hepatitis C or HIV infection.
• Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
• Check if you have previously received a treatment that attaches to the protein called CD19.

In some cases, it might not be possible to go ahead with the planned treatment with Tecartus. If Tecartus infusion is delayed for more than 2 weeks after you have received lymphodepleting chemotherapy you may have to receive more chemotherapy (see also section 3, How Tecartus is given).

After you have been given Tecartus

Tell your doctor or nurse immediately or get emergency help right away if you have any of the following:

• Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, rapid or irregular heartbeat, severe nausea, vomiting, or diarrhoea which may be symptoms of a condition known as cytokine release syndrome. Take your temperature twice a day for 3 to 4 weeks after treatment with Tecartus. If your temperature is high, see your doctor immediately.
• Fits, shaking, 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 above 38°C), which may be a symptom of an infection.
• Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
• Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.

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

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

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

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

Tecartus must not be used in children and adolescents below 18 years of age or young adults below 26 years of age.

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 medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of Tecartus.

In particular, you must not be given certain vaccines called live vaccines:

• In the 6 weeks before you are given the short course of lymphodepleting chemotherapy to prepare your body for the Tecartus cells.
• During Tecartus treatment.
• After treatment while the immune system is recovering.

Talk to your doctor if you need to have any vaccinations.

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 in pregnant or breast-feeding women are not known, and it may harm your unborn baby or your breast-fed child.

• If you are pregnant or think you may be pregnant after treatment with Tecartus, talk to your doctor immediately.
• You will be given a pregnancy test before treatment starts. Tecartus can only be given if the results show you are not pregnant.

Discuss pregnancy with your doctor if you have received Tecartus.

Tecartus can cause problems such as altered or decreased consciousness, confusion and seizures (fits) in the 8 weeks after it is given.

Do not drive, use machines, or take part in activities that need you to be alert for at least 8 weeks after your Tecartus treatment or until your doctor tells you that you have completely recovered.

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

A few days before you receive Tecartus, you will be given lymphodepleting chemotherapy, which will allow the modified white blood cells in Tecartus to multiply in your body when the medicine is given to you.

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.

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

• Tecartus is given in a single dose.
• Your doctor or nurse will give you a single infusion of Tecartus through a catheter placed into your vein (intravenous infusion) over about 30 minutes.
• Tecartus is the genetically modified version of your white blood cells. Your healthcare professional handling the treatment will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases and will follow local guidelines on handling of waste of human-derived material to clean up or dispose of any material that has been in contact with it.

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

Other side effects are listed below. If these side effects become severe or serious, tell your doctor immediately.

Very common: may affect more than 1 in 10 people

• Abnormally low number of white blood cells, which may increase your risk of infection.
• Low number of cells that help clot the blood (thrombocytopenia): symptoms can include excessive or prolonged bleeding or bruising.
• High blood pressure.
• Decrease in the number of red blood cells (cells that carry oxygen): symptoms can include extreme tiredness with a loss of energy.
• Extreme tiredness.
• Fast or slow heartbeat.
• Decrease of oxygen reaching body tissues: symptoms can include changes to the colour of your skin, confusion, rapid breathing.
• Shortness of breath, cough.
• Excessive bleeding.
• Nausea, constipation, diarrhoea, abdominal pain, vomiting.
• Muscle pain, joint pain, bone pain, pain in the extremities of the body.
• Lack of energy or strength, muscular weakness, difficulty moving, muscle spasm.
• Headache.
• Kidney problems causing your body to hold onto fluid, build-up of fluids in tissue (oedema) which can lead to weight gain and difficulty in breathing.
• High levels of uric acid and sugar (glucose) seen in blood tests.
• Low levels of sodium, magnesium, phosphate, potassium or calcium seen in blood tests.
• Decreased appetite, sore mouth.
• Difficulty sleeping, anxiety.
• Swelling in the limbs, fluid around the lungs (pleural effusion).
• Skin rash or skin problems.
• Low levels of immunoglobulins seen in blood test, which may lead to infections.
• Increase in liver enzymes seen in blood tests.
• Nerve pain.

Common: may affect up to 1 in 10 people

• Low levels of albumin seen in blood tests.
• High levels of bilirubin seen in blood tests.
• Irregular heartbeat (arrhythmia).
• Loss of control of body movements.
• Dry mouth, dehydration, difficulty swallowing.
• Decreased output of urine (due to kidney problems described above).
• Breathlessness (respiratory failure).
• Difficulty breathing which makes you unable to speak in full sentence, cough due to fluid in the lungs.
• Increase of the pressure inside your skull.
• Blood clots: symptoms can include pain in the chest or upper back, difficulty breathing, coughing up blood or cramping pain, swelling in a single leg, warm and darkened skin around the painful area.
• Alteration of the blood ability to form clots (coagulopathy): symptoms can include excessive or prolonged bleeding or bruising.
• Changes in vision which makes it difficult to see things (visual impairment).
• Infusion related reactions: symptoms including dizziness or fainting, flushing, rash, itching, fever, shortness of breath or vomiting, abdominal pain, and diarrhoea
• Hypersensitivity: symptoms such as rash, hives, itching, swelling and anaphylaxis.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is brexucabtagene autoleucel (0.4 – 2 × 10⁸ cells dispersion for infusion). Each patient-specific single infusion bag contains a dispersion of anti-CD19 CAR-positive viable T cells in approximately 68 mL for a target dose of 2 × 10⁶ anti-CD19 CAR-positive viable T cells/kg for mantle cell lymphoma patients and a target dose of 1 × 10⁶ anti-CD19 CAR-positive viable T cells/kg for B-cell acute lymphoblastic leukaemia patients.

The other ingredients (excipients) are: Cryostor CS10 (contains DMSO), sodium chloride, human albumin. See section 2 “Tecartus contains sodium, dimethyl sulphoxide (DMSO), and residual gentamicin”.

This medicine contains genetically modified human blood cells.

Tecartus is a clear to opaque, white to red dispersion for infusion, supplied in an infusion bag individually packed in a metal cassette. A single infusion bag contains approximately 68 mL of cell dispersion.