Abecma 260 - 500 x 10^6 cells dispersion for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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 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 Abecma is and what it is used for
2. What you need to know before you are given Abecma
3. How Abecma is given
4. Possible side effects
5. How to store Abecma
6. Contents of the pack and other information

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.

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

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

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

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

• 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.

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

• you have any lung or heart problems.
• have problems with your nervous system (such as fits, stroke, or memory loss).
• you have low blood pressure.
• you have had a stem cell transplant in the last 4 months.
• 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.
• 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.
• you have had cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection.
• you have had a vaccination in the previous 6 weeks or are planning to have one in the next few months.

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

Patients treated with Abecma 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 Abecma 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.

Before you are given Abecma your doctor will:

• Check your lungs, heart and blood pressure.
• Look for signs of infection; any infection will be treated before you are given Abecma.
• Check if your cancer is getting worse.
• Check for CMV infection, hepatitis B, hepatitis C or HIV infection.

After you have been given Abecma

• There are serious side effects which you need to tell your doctor or nurse about straight away and which may require you to get immediate medical attention. 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 Abecma for at least 4 weeks. See sections 3 and 4.
• Do not donate blood, organs, tissues or cells for transplantation.

Abecma should not be given to children and adolescents below 18 years of age.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Before you are given Abecma, 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 interfere with the effect of Abecma.

See section 3 for information about the medicines you will be given before having Abecma.

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

Discuss pregnancy with your doctor if you have received Abecma.

Do not drive, use machines or take part in activities that need you to be alert for at least 8 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).

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.

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.

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

• 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.
• Your white blood cells will then be frozen and sent away to make 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.

• 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.

• Stay close to the treatment centre where you received Abecma - for at least 4 weeks.
• You may be monitored daily in the treatment centre for at least 10 days 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.

Call your doctor or the treatment centre as soon as possible to make another appointment.

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:

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.
• any signs of an infection, which may include fever, chills or shivering, cough, shortness of breath, rapid breathing and rapid pulse.
• feeling very tired or weak or short of breath -which may be signs of low levels of red blood cells (anaemia).
• 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.

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.

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).

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

Very common: may affect more than 1 in 10 people

• lack of energy
• high blood pressure
• decreased appetite
• constipation
• swollen ankles, arms, legs and face
• joint pain
• difficulty sleeping
• 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
• 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.

Common: may affect up to 1 in 10 people

• severe inflammation due to activation of your immune system which could lead to serious damage in the body
• muscle pain
• abnormal body movements or lack of coordination
• uneven or irregular heartbeat
• fluid in the lungs
• low oxygen level in the blood, which may cause shortness of breath, confusion or drowsiness.

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

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

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: at 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 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 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”.

This medicine contains genetically modified human blood cells.

Abecma is a colourless cell dispersion for infusion, supplied in one or more infusion bags individually packed in a metal cassette. Each bag contains 10 mL to 100 mL of cell dispersion.