Patient leaflet - Breyanzi 1.1-70 x 10^6 Cells/ml / 1.1-70 x 10^6 Cells/ml Dispersion for infusion
1. What Breyanzi is and what it is used for
What Breyanzi is
Breyanzi contains the active substance lisocabtagene maraleucel, a type of
treatment called ‘genetically modified cell therapy’.
Breyanzi is made from your own white blood cells. This involves taking some of
your blood and separating out the white blood cells and sending the white blood
cells to a laboratory so that they can be modified to make Breyanzi.
What Breyanzi is used for
Breyanzi is used to treat adults with a type of blood cancer called lymphoma
which affects your lymph tissue and causes white blood cells to grow out of
control. Breyanzi is used for:
- diffuse large B-cell lymphoma
- high-grade B-cell lymphoma
- primary mediastinal large B-cell lymphoma
- follicular lymphoma.
- mantle cell lymphoma
How Breyanzi works
Breyanzi cells have been genetically modified to recognise the lymphoma
cells in your body.
When these cells are then introduced back into your blood, they can
recognise and attack the lymphoma cells.
2. What you need to know before you are given Breyanzi
You should not be given Breyanzi:
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 cannot receive treatment, called lymphodepleting chemotherapy, which
reduce the number of white blood cells in your blood (see also section 3, How
Breyanzi is given).
Warnings and precautions
Before you are given Breyanzi you should tell your doctor if:
- you have any lung or heart problems
- you have low blood pressure
you have an infection or other inflammatory conditions. The infection will be
treated before you are given Breyanzi
you have had a stem cell transplant from another person in the last 4 months –
the transplanted cells can attack your body (graft-versus-host disease), causing
symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools
you notice the symptoms of your cancer are getting worse. These symptoms
include fever, feeling weak, night sweats, sudden weight loss
- you have had hepatitis B or C, or human immunodeficiency (HIV) infection
you had a vaccination in the last 6 weeks or you are planning to have one in
the next few months. See Live vaccines below for more information.
If any of the above apply to you (or you are not sure), talk to your doctor before
being given Breyanzi.
Patients treated with Breyanzi may develop new types of cancers. There have
been reports of patients developing cancer, beginning in a type of white blood
cells called T-cells, after treatment with Breyanzi and similar medicines. Talk to
your doctor if you experience any new swelling of your glands (lymph nodes) or
changes in your skin such as new rashes or lumps.
Tests and checks
Before you are given Breyanzi, your doctor will:
- check your lungs, heart and blood pressure
look for signs of infection – any infection will be treated before you receive
Breyanzi
look for signs of graft-versus-host disease, which can happen after a stem cell
transplant from another person
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 if your cancer is getting worse
- check for hepatitis B and C, and HIV infection
After you have been given Breyanzi
If you get certain serious side effects, you must tell your doctor or nurse
straight away because you may need treatment for them. See section 4 under
‘Serious side effects’.
Your doctor will regularly check your blood counts, as the number of blood
cells may decrease.
Stay close to the treatment centre where you had Breyanzi for at least 2 weeks.
Your doctor may recommend you stay longer to make sure the care you get
after your treatment meets your individual needs. See sections 3 and 4.
- Do not donate blood, organs, tissues or cells for transplantation.
You will be asked to enrol in a registry for at least 15 years in order to better
understand the long-term effects of Breyanzi.
Children and adolescents
Breyanzi should not be given to children and adolescents below 18 years of age.
Other medicines and Breyanzi
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines including medicines taken without a prescription.
See section 3 for information about the medicines you will be given before
having Breyanzi.
Medicines that affect your immune system
Before you are given Breyanzi tell your doctor or nurse if you are taking any
medicines that weaken your immune system such as:
- corticosteroids.
This is because these medicines may reduce the effect of Breyanzi.
Other medicines that treat cancer
Some anti-cancer medicines could reduce the effect of Breyanzi. Your doctor will
consider if you need other cancer treatments.
Live vaccines
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 Breyanzi.
- during Breyanzi treatment
- after treatment while your 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 or
lymphodepleting chemotherapy. The effects of Breyanzi in pregnant or
breast-feeding women are not known, and it may harm your unborn baby or
breast-fed child.
If you are pregnant or think you may be pregnant after treatment with Breyanzi,
talk to your doctor immediately.
You will be given a pregnancy test before treatment starts. Breyanzi should
only be given if the result shows you are not pregnant.
Discuss the need for contraception with your doctor.
Discuss pregnancy with your doctor if you have received Breyanzi.
Driving and using machines
Do not drive, use machines, or take part in activities that need you to be alert for
at least 4 weeks after treatment. Breyanzi can make you sleepy, decrease
awareness, and cause confusion and seizures (fits). Based on your individual
needs, your doctor may advise you to wait longer before driving.
Breyanzi contains sodium, potassium and dimethyl sulfoxide (DMSO)
This medicine contains up to 12.5 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 0.6% of the recommended maximum daily intake of sodium for an adult. Up to 8 vials of this medicine may be given per dose, which in total contains 100 mg sodium or 5% of the recommended maximum daily intake of sodium for an adult.
This medicine contains up to 0.2 mmol (or 6.5 mg) potassium per dose. Your doctor will take this potassium content into consideration if your kidneys do not work properly or you are on a controlled potassium diet. This medicine also contains DMSO which may cause severe hypersensitivity reactions.
3. How Breyanzi is given
Patient Card
- Your doctor will give you a Patient Card. Read it carefully and follow the instructions on it.
- Always show the Patient Card to the doctor or nurse when you see them or if you go to hospital.
Giving blood to make Breyanzi from your white blood cells
Breyanzi is made from your own white blood cells
- Your doctor will take some of your blood by putting a tube (catheter) in your vein. Some of your white blood cells will be separated from your blood. The rest of your blood is returned to your body. This is called leukapheresis and can take 3 to 6 hours. This process may need to be repeated. • Your white blood cells will then be sent away to make Breyanzi.
Other medicines you will be given before Breyanzi
- A few days before you receive Breyanzi, you will be given a short course of chemotherapy. This is to clear away your existing white blood cells. • Shortly before you receive Breyanzi, you will be given paracetamol and an antihistamine medicine. This is to reduce the risk of infusion reactions and fever.
How Breyanzi is given
- Your doctor will check that the Breyanzi was prepared from your own blood by checking that the patient identity information on the medicine labels matches your details.
- Breyanzi is given by infusion (drip) through a tube into a vein. • You will receive infusions of the CD8 positive cells, followed immediately by infusions of the CD4 positive cells. The time for infusion will vary, but will usually be less than 15 minutes for each of the 2 cell types.
After Breyanzi is given
- Stay close to the treatment centre where you received Breyanzi – for at least 2 weeks.
- During the first week after treatment, you will need to return to the treatment centre 2 to 3 times so that your doctor can check that the treatment is working – and to help you with any side effects. See sections 2 and 4.
If you miss an appointment
Call your doctor or the treatment centre as soon as possible to make another appointment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately if you get any of the following side effects after being given Breyanzi:
- fever, chills or shaking, feeling tired, fast or uneven heartbeat, feeling light-headed and short of breath – these may be signs of a serious problem called cytokine release syndrome
- confusion, being less alert (decreased consciousness), difficulty speaking or slurred speech, shaking (tremor), feeling anxious, feeling dizzy and headache – these may be symptoms of a condition called immune effector cell-associated neurotoxicity syndrome (ICANS), or signs of problems with your nervous system
feeling warm, fever, chills or shivering – these may be signs of infection The infections may be caused by:
- low levels of white blood cells, which help fight infections, or - low levels of antibodies called immunoglobulins
- blurred vision, loss of vision or double vision, difficulty speaking, weakness or clumsiness of an arm or a leg, a change in the way you walk or problems with your balance, personality changes, changes in thinking, memory and orientation leading to confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). These symptoms may start several months after treatment has ended and they usually develop slowly and gradually over weeks or months. It is important that your relatives or caregivers are also aware of these symptoms, since they may notice symptoms that you are not aware of.
- feeling very tired, weak and short of breath – these may be signs of low red blood cell levels (anaemia)
bleeding or bruising more easily –these may be signs of low levels of blood cells known as platelets.
Tell your doctor immediately if you get any of the side effects above after being given Breyanzi, as you may need urgent medical treatment.
Other possible side effects
Very common: may affect more than 1 in 10 people
- difficulty sleeping • low blood pressure including signs such as dizziness, passing out, or change in eyesight • cough • feeling sick or being sick • diarrhoea or constipation • stomach pain • swollen ankles, arms, legs and face • rash
Common: may affect up to 1 in 10 people
- trouble with balancing or walking • high blood pressure which may include signs of very bad headaches, sweating or trouble sleeping • changes in vision • changes in the way things taste • numbness and tingling in the feet or hands • blood clots or problems with blood clotting • bleeding in your gut • passing less urine • infusion reactions – such as feeling dizzy, fever, and shortness of breath • low blood levels of phosphates • low levels of oxygen in the blood
Uncommon: may affect up to 1 in 100 people
- a new type of cancer beginning in a type of white blood cells called T cells (secondary malignancy of T cell origin) • the fast breakdown of cancer cells, resulting in the release of toxic waste products into the bloodstream – a sign may be dark urine with symptoms of nausea or pain on side of stomach • severe inflammatory condition – symptoms may include fever, rash, enlarged liver, spleen and lymph nodes • heart weakness, causing shortness of breath and ankle swelling • fluid around the lungs • stroke or mini-strokes • convulsions or seizures (fits) • weakness of the face muscles, vocal cords or weakness in the body • swelling of the brain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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.
5. How to store Breyanzi
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 cartons and vial label after ‘EXP’.
Store frozen in the vapour phase of liquid nitrogen (≤ -130 °C).
6. Contents of the pack and other information
What Breyanzi contains
- The active substance is lisocabtagene maraleucel. Each 4.6 mL vial contains a dispersion of CAR-positive viable T-cells (CD8 positive cell component or CD4 positive cell component) with a strength of 1.1 × 106 to 70 × 106 CAR positive viable T cells/mL for each cell component. There may be up to 4 vials of each of the CD8 positive or CD4 positive cell components, depending upon the concentration of cryopreserved medicine.
- The other ingredients (excipients) are Cryostor CS10 (contains dimethyl sulfoxide or DMSO), sodium chloride, sodium gluconate, sodium acetate trihydrate, potassium chloride, magnesium chloride, human albumin, N-acetyl-DL-tryptophan, caprylic acid, water for injections. See section 2, “Breyanzi contains sodium, potassium and dimethyl sulfoxide (DMSO)”.
This medicine contains genetically modified human blood cells.
What Breyanzi looks like and contents of the pack
Breyanzi is a cell dispersion for infusion. It is supplied as vials of slightly opaque to opaque, colourless to yellow, or brownish-yellow dispersion. Each vial contains 4.6 mL cell dispersion of either CD8 positive or CD4 positive cell component.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland
1466889A1
PRD-005975-5
Manufacturer(s)
BMS Netherlands Operations B.V.
Francois Aragostraat 2
2342 DK Oegstgeest
Netherlands
This leaflet was last revised in 04/2026
Approved 11.0v