Abecma 260 - 500 x 106 cells dispersion for infusion – patient leaflet, side effects, dosage

1. What Abecma is and what it is used for

You must not be given certain vaccines called live vaccines: • in the 6 weeks before you are given a short course of chemotherapy (called lympodepleting chemotherapy) to prepare your body for Abecma. • during Abecma treatment.

1. 2. What you need to know before you are given Abecma
2. 3. How Abecma is given
3. 4. Possible side effects
4. 5.
   • after treatment while the immune system is recovering.
5. 6.

   Contents of the pack and other information

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

6. 1.

   What Abecma is and what it is used for

   Pregnancy and breast-feeding

What Abecma is

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 Abecma 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 Abecma, talk to your doctor immediately.

Abecma is a type of medicine called a ‘genetically modified cell therapy’. The active substance in the medicine is idecabtagene vicleucel, which is made from your own white blood cells, called T cells.

What Abecma is used for

Abecma is used to treat adults with multiple myeloma, which is a cancer of the bone marrow.

• You will be given a pregnancy test before treatment starts. Abecma should only be given if the results show you are not pregnant.

It is given when previous treatments for your cancer have not worked or the cancer has come back.

Discuss pregnancy with your doctor if you have received Abecma.

How Abecma works

Driving and using machines

The white blood cells are taken from your blood and are genetically modified so that they can target the myeloma cells in your body.

Do not drive, use machines or take part in activities that need you to be alert for at least 4 weeks after treatment or until your doctor tells you that you have completely recovered. Abecma may make you feel sleepy, may cause confusion or fits (seizures). Based on your individual needs, your doctor may advise you to wait longer before driving.

When Abecma is infused into your blood, the modified white blood cells will kill the myeloma cells.

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

Abecma contains sodium, potassium and dimethyl sulfoxide (DMSO)

You must not be given Abecma

This medicine contains up to 752 mg sodium (main component of cooking/ table salt) per dose. This is equivalent to 37.6% of the recommended maximum daily intake of sodium for an adult.

• 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 are allergic to any of the ingredients in the medicines you will be given for lymphodepleting chemotherapy, which is used to prepare your body for Abecma treatment.

  This medicine contains up to 274 mg potassium per dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Warnings and precautions

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

If you have not been previously exposed to DMSO you should be observed closely during the first minutes of the infusion period.

• you have any lung or heart problems.
• have problems with your nervous system (such as fits, stroke, or memory loss).

3. How Abecma is given

• you have low blood pressure.

• you have had a stem cell transplant in the last 4 months.

  Giving blood to make Abecma from your white blood cells

• you 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.

  • Your doctor will take some of your blood using a tube (catheter) in your vein. Some of your white blood cells will be separated from your blood and 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.
• you have an infection. The infection will be treated before you are given Abecma.

• you notice the symptoms of your cancer getting worse. In myeloma these might include fever, feeling weak, bone pain, unexplained weight loss.

  be coordinated. The infusion start time should be confirmed in advance and adjusted for thaw so that Abecma is available for infusion when the patient is ready.

The following information is intended for healthcare professionals only:

It is important that you read the entire content of this procedure prior to administering Abecma.

Thawing

• Remove the Abecma infusion bag from the cassette and inspect the infusion bag for any breaches of container integrity such as breaks or cracks before thawing. If the infusion bag appears to have been damaged or to be leaking, it should not be infused and should be disposed of according to local guidelines on handling of waste of human-derived material. • Place the infusion bag inside a second sterile bag.

Precautions to be taken before handling or administering the medicinal product • Abecma must be transported within the facility in closed, break-proof, leak-proof containers.

• This medicinal product contains human blood cells. Healthcare professionals handling Abecma must take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

  • Thaw Abecma at approximately 37°C using an approved thaw device or water bath until there is no visible ice in the infusion bag. Gently mix the contents of the bag to disperse visible clumps of cellular material. Small clumps of cellular material may persist despite gentle manual mixing. Do not wash, spin down and/or resuspend Abecma in new media prior to infusion.

Preparation prior to administration

• Prior to Abecma infusion, it must be confirmed that the patient’s identity matches the patient identifiers on the Abecma cassette(s), the infusion bag(s) and the release for infusion certificate (RfIC).

  Administration

• The Abecma infusion bag must not be removed from the cassette if the information on the patient-specific label does not match the intended patient. The company must be contacted immediately if there are any discrepancies between the labels and the patient identifiers.

  • Do NOT use a leukodepleting filter.
  • Intravenous infusion of Abecma should only be administered by a healthcare professional experienced with immunosuppressed patients and prepared to manage anaphylaxis.

• If more than one infusion bag has been received for treatment, thaw each infusion bag one at a time. The timing of thaw of Abecma and infusion should

  • Ensure that tocilizumab and emergency equipment are available prior to infusion and during the recovery period. In the exceptional case where

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    Other medicines you will be given before Abecma

    • A few days before you receive Abecma, you will be given a short course of chemotherapy (called lymphodepleting chemotherapy). This is to clear away your existing white blood cells. If Abecma infusion is delayed for more than 4 weeks after you have received lymphodepleting chemotherapy you should receive more preparative chemotherapy.
    • Shortly before you receive Abecma, you will be given paracetamol and an antihistamine medicine. This is to reduce the risk of infusion reactions and fever.

How Abecma is given

• Your doctor will check that the Abecma was prepared from your own blood by checking the patient identity information on the medicine labels matches your details.

• Abecma is given as an infusion drip through a tube into your vein.

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After Abecma is given

• Stay close to the treatment centre where you received Abecma - for at least 2 weeks.
• You may be monitored daily in the treatment centre for at least 1 week to check if your treatment is working - and help you if you have any side effects. See sections 2 and 4.
• Do not donate blood, organs, tissues or cells for transplantation.

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.

Rare: may affect up to 1 in 1,000 people

Serious side effects

• a new type of cancer beginning in a type of white blood cells called T cells (secondary malignancy of T cell origin).

Tell your doctor immediately if you get any of the following side effects after being given Abecma. They usually happen in the first 8 weeks after the infusion, but can also develop later:

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 Yellow Card Scheme

Very common: may affect more than 1 in 10 people

• fever, chills, difficulty breathing, dizziness or light-headedness, nausea, headache, fast heartbeat, low blood pressure or fatigue - these may be symptoms of cytokine release syndrome or CRS, a serious and potentially fatal condition.

  Website: at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

• any signs of an infection, which may include fever, chills or shivering, cough, shortness of breath, rapid breathing and rapid pulse.

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

• feeling very tired or weak or short of breath, which may be signs of low levels of red blood cells (anaemia).

5. How to store Abecma

• bleeding or bruising more easily without cause, including nosebleeds or bleeding from the mouth or bowels, which may be a sign of low levels of platelet cells in your blood.

  The following information is intended for doctors only.

  Do not use this medicine after the expiry date which is stated on the cassette label and infusion bag label after ‘EXP’.

Common: may affect up to 1 in 10 people

• shaking, weakness with loss of movement on one side of the body, tremor, slow movements, or stiffness, which may be symptoms of parkinsonism.

  Stored and transport frozen in the vapour phase of liquid nitrogen (≤ -130°C). Do not thaw the product until it is ready to be used. Do not refreeze.

Uncommon: may affect up to 1 in 100 people

• confusion, difficulty with memory, difficulty speaking or slowed speech, difficulty understanding speech, loss of balance or coordination, disorientation, being less alert (decreased consciousness) or excessive sleepiness, loss of consciousness, delirious, fits (seizures), which may be symptoms of a condition called immune effector cell-associated neurotoxicity syndrome (ICANS).

  Do not use this medicine if the infusion bag is damaged or leaking.

6. Contents of the pack and other information

What Abecma contains

• The active substance is idecabtagene vicleucel. Each infusion bag of Abecma contains idecabtagene vicleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-BCMA chimeric antigen receptor (CAR-positive viable T cells). One or more infusion bags contain a total of 260 to 500 × 10⁶

Tell your doctor immediately if you get any of the side effects above, as you may need urgent medical treatment.

Other possible side effects

CAR-positive viable T cells.

• The other ingredients (excipients) are Cryostor CS10, sodium chloride, sodium gluconate, sodium acetate trihydrate, potassium chloride, magnesium chloride, water for injections. See section 2, “Abecma contains sodium, potassium and DMSO”.

Very common: may affect more than 1 in 10 people

• lack of energy
• high blood pressure
• decreased appetite

• constipation

  This medicine contains genetically modified human blood cells.

• swollen ankles, arms, legs and face

• joint pain

  What Abecma looks like and contents of the pack

• difficulty sleeping

  Abecma is a colourless cell dispersion for infusion, supplied in one or more infusion bags individually overwrapped with a transparent plastic sleeve that is folded to the back of the infusion bag and packed in a metal cassette. Each bag contains 10 mL to 100 mL of cell dispersion.

• low number of white blood cells (neutrophils, leucocytes and lymphocytes), which can increase your risk of infection

• infections including pneumonia or infections of the respiratory tract, mouth, skin, urinary tract or blood, which may be bacterial, viral or fungal • laboratory test results showing low levels of antibodies, called immunoglobulins (hypogammaglobulinaemia) that are important in fighting infections • laboratory test results showing decreased levels of calcium, sodium, magnesium, potassium, phosphate or albumin, which may cause fatigue, muscle weakness or cramps or an irregular heartbeat

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• laboratory test results showing increased levels of liver enzymes (abnormal liver function test) or a higher level of a protein (C-reactive protein) in blood that may indicate inflammation.

  Ireland

  Manufacturer

  BMS Netherlands Operations B.V.

Common: may affect up to 1 in 10 people

Francois Aragostraat 2

• severe inflammation due to activation of your immune system which could lead to serious damage in the body

  2342 DK Oegstgeest

  Netherlands

• muscle pain

• abnormal body movements or lack of coordination

  This leaflet was last revised in 12/2025

• uneven or irregular heartbeat
• fluid in the lungs

• low oxygen level in the blood, which may cause shortness of breath, confusion or drowsiness.

  Measures to take in case of accidental exposure

  tocilizumab is not available due to a shortage that is listed in the MHRA Central Alerting System, ensure that suitable alternative measures to treat CRS instead of tocilizumab are available on-site.

  • In case of accidental exposure, local guidelines on handling of human-derived material must be followed. Work surfaces and materials which have potentially been in contact with Abecma must be decontaminated with appropriate disinfectant.
• Central venous access may be utilised for the infusion of Abecma and is encouraged in patients with poor peripheral access.

• Before administration, it must be confirmed that the patient’s identity matches the unique patient information on the Abecma infusion bag and accompanying documentation. The total number of infusion bags to be administered must also be confirmed with the patient specific information on the release for infusion certificate (RfIC).

  Precautions to be taken for the disposal of the medicinal product • Unused medicinal product and all material that has been in contact with Abecma (solid and liquid waste) must be handled and disposed of as potentially infectious waste in accordance with local guidelines on handling of human-derived material.

• Prime the tubing of the infusion set with sodium chloride 9 mg/mL (0.9%) solution for injection prior to infusion. Infusion set with in-line filter (NOT a leukodepleting filter) can be used for thawed products with visible clumps of cellular material that do not disperse after gentle manual mixing. • Infuse Abecma within 1 hour from start of thaw as quickly as tolerated by gravity flow.
• After the entire content of the infusion bag is infused, rinse the tubing, inclusive of the in-line filter if used, with sodium chloride 9 mg/mL (0.9%) solution for injection at the same infusion rate to ensure as many cells as possible are infused into the patient.
• Follow the same procedure for all subsequent infusion bags for the identified patient.