What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/18/1299/001 .


YESCARTA (Northern Ireland)

Package leaflet: Information for the patient

Yescarta 0.4 – 2 x 108 cells dispersion for infusion

axicabtagene ciloleucel (CAR+ viable T cells)

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given 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 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.

What is in this leaflet

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

1. What Yescarta is and what it is used for

Yescarta is a type of medicine called a “genetically modified cell therapy”.

Yescarta is made specially for you as a single administration of your own modified white blood cells. It is given by a drip (infusion) into a vein (intravenously).

It is used to treat aggressive conditions in adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body. Too many of these abnormal white blood cells accumulate in your tissue and this is the cause of the symptoms you may have. It is used to treat these conditions when other available medicines have stopped working for you.

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

You should not be given Yescarta 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.

Warnings and precautions

Yescarta is made from your own white blood cells and should only be given to you.

Before you are given Yescarta you should tell your doctor if you:

  • have problems with your nervous system (such as fits, stroke, or memory loss).
  • have kidney problems.
  • have low blood cell levels (blood counts).
  • have had a stem cell transplant in the last 4 months.
  • have any lung, heart or blood pressure (low or raised) problems.
  • have signs or symptoms of graft-versus-host disease. This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.
  • notice the symptoms of your cancer are getting worse. If you have lymphoma this might include fever, feeling weak, night sweats, sudden weight loss.
  • have an infection. The infection will be treated before the Yescarta infusion.
  • have had hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.

If any of the above apply to you (or you are not sure), talk to your doctor before being given Yescarta.

Tests and checks

Before you are given Yescarta your doctor will:

  • Check your lungs, heart and blood pressure.
  • Look for signs of infection; any infection will be treated before you are given Yescarta.
  • Check if your cancer is getting worse.
  • Look for signs of graft-versus-host disease that can happen after a transplant.
  • 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.

After you have been given Yescarta

Tell your doctor or nurse immediately if you have any of the following:

  • Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, or rapid heartbeat, which may be symptoms of a condition known as cytokine release syndrome. Take your temperature twice a day for 3-4 weeks after treatment with Yescarta. 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, 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.

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

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

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you are given Yescarta. Your doctor may need to take special care of you during your treatment with Yescarta.

In some cases, it might not be possible to go ahead with the planned treatment with Yescarta. For example:

  • If Yescarta infusion is delayed for more than 2 weeks after you have received preparatory chemotherapy you may have to receive more preparative chemotherapy.

Children and adolescents

Yescarta should not be used in children and adolescents below 18 years of age.

Other medicines and Yescarta

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

Before you are given Yescarta 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 Yescarta.

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

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

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

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 Yescarta 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 Yescarta, talk to your doctor immediately.
  • You will be given a pregnancy test before treatment starts. Yescarta should only be given if the results show you are not pregnant.

Discuss pregnancy with your doctor if you have received Yescarta.

Driving and using machines

Some people may feel tired, dizzy or have some shaking after being given Yescarta. If this happens to you, do not drive or use heavy machines until at least 8 weeks after infusion or until your doctor tells you that you have completely recovered.

Yescarta contains sodium

This medicine contains 300 mg sodium (main component of cooking/table salt) in each infusion. This is the equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.

3. How Yescarta is given

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

  • Since Yescarta is made from your own white blood cells, your cells will be collected from you to prepare your medicine. Your doctor will take some of your blood using a catheter placed in your vein (a procedure call leukapheresis). Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein. This can take 3 to 6 hours and may need to be repeated.
  • Your white blood cells are frozen and sent away to make Yescarta. It usually takes about 3 to 4 weeks to receive your Yescarta therapy but the time may vary.

Medicines given before Yescarta treatment

During the 30 to 60 minutes before you are given Yescarta 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.

Prior to receiving Yescarta, you will be given other medicines such as preparative chemotherapy, which will allow your modified white blood cells in Yescarta to multiply in your body when the medicine is given to you.

Your doctor or nurse will check carefully that this medicine is yours.

How you are given Yescarta

  • Yescarta is a one-time treatment. It will not be given to you again.
  • Your doctor or nurse will give you a single infusion of Yescarta into your vein for approximately 30 minutes.
  • Yescarta contains human blood cells. Your doctor handling Yescarta will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

You must receive Yescarta infusion in a qualified clinical facility and be discharged only when your doctor thinks it is safe for you to go home.

Your doctor may do blood tests to check for side effects.

After you are given Yescarta

  • Plan to stay within proximity from the hospital where you were treated for at least 4 weeks after you have been given Yescarta. Your doctor will recommend that you return to the hospital daily for at least 10 days and will consider whether you need to stay at the hospital as an in-patient for the first 10 days after infusion. This is so your doctor can check if your treatment is working and help you if you have any side effects.

If you miss any appointments, call your doctor or the qualified clinical facility as soon as possible to reschedule your appointment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Yescarta can cause side effects to your immune system that may be serious or life-threatening, and can lead to death.

The following side effects have been reported with Yescarta.

Very common (may affect more than 1 in 10 people)

  • Fever, chills, reduced blood pressure which may cause symptoms such as dizziness, lightheadedness, fluid in the lungs, which may be severe and can be fatal (all symptoms of a condition called cytokine release syndrome).
  • Fever or chills.
  • Decrease in the number of red blood cells (cells that carry oxygen) which may cause you to feel extremely tired with a loss of energy.
  • Low blood pressure, dizziness.
  • Feeling sick, constipation, diarrhoea, pain in the stomach or being sick.
  • Headache, depressed level of consciousness, difficulty in speaking, agitation, shaking.
  • Decrease in the number of white blood cells, which are important for fighting infections.
  • Decreased levels of sodium, phosphate, or potassium which will show up on blood tests.
  • Changes in the rhythm or rate of the heartbeat.
  • Anxiety.
  • Decrease in the number of cells that help clot the blood (thrombocytopenia).
  • Infections in the blood caused by bacteria, viruses or other types of infection.
  • Shortness of breath, cough.
  • Low levels of antibodies called immunoglobulins, which may lead to infections.
  • High blood pressure.
  • Swelling in the limbs, fluid around the lungs (pleural effusion).
  • Muscle and joint pain, back pain.
  • Extreme tiredness.
  • Dehydration.
  • Decreased appetite, weight loss.
  • Confusion.
  • Increased levels of liver enzymes which will show up on blood tests.
  • Dry mouth.
  • Low oxygen level in blood.
  • Pain in the hands or feet.

Common (may affect up to 1 in 10 people)

  • Difficulty understanding numbers, memory loss, fits, loss of control of body movements.
  • Failure of the kidneys causing your body to hold onto fluid which can be serious or life threatening.
  • Fluid in the lungs.
  • Lung infection.
  • Sudden, unexpected stopping of the heart (cardiac arrest); this is serious and life-threatening.
  • Heart failure.
  • Muscle spasms.
  • Difficulty to swallow.
  • Leakage of fluids from blood vessels into surrounding tissue. This can lead to a weight gain and difficulty in breathing.
  • Decreased levels of calcium which will show up on blood tests.
  • Infections in the blood caused by fungi.
  • Decreased levels of albumin which will show up on blood tests.
  • Skin rash.
  • Increased levels of bilirubin reporting on how your liver is working, which will show up on blood tests.
  • Signs and symptoms of blood clots.
  • Difficulty sleeping.
  • Hypersensitivity.

Uncommon (may affect up to 1 in 100 people)

  • Inflammation and swelling of spinal cord which may cause partial or total paralysis of limbs and torso.

Tell your doctor immediately if you get any of the side effects listed above. Do not try to treat your symptoms with other medicines on your own.

Reporting of side effects

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 national reporting system:

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance
Website: www.hpra.ie

Malta

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Yescarta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container label and infusion bag.

Store frozen in vapour phase of liquid nitrogen ≤ -150 °C until thawed for use.

Do not refreeze.

As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product. These measures will help protect the environment. This medicine contains genetically modified blood cells. Local guidelines on handling biological waste should be followed for unused medicine or waste material.

6. Contents of the pack and other information

What Yescarta contains

The active substance is axicabtagene ciloleucel. Each patient-specific single infusion bag contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.

The other ingredients (excipients) are: Cryostor CS10, sodium chloride, human albumin. See section 2 “Yescarta contains sodium”.

What Yescarta looks like and contents of the pack

Yescarta 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.

Marketing Authorisation Holder and Manufacturer

Kite Pharma EU B.V.
Tufsteen 1
2132 NT Hoofddorp
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Gilead Sciences Ltd
Tel: + 44 (0) 8000 113700

This leaflet was last revised in 06/2020

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.