Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - abecma

Document Subject

Generated Narrative: MedicinalProductDefinition mp7e98051b7b877024b322905712140ea8

identifier: http://ema.europa.eu/identifier/EU/1/21/1539/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Abecma 260 - 500 x 106 cells dispersion for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7e98051b7b877024b322905712140ea8

identifier: http://ema.europa.eu/identifier/EU/1/21/1539/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - abecma

Attesters

What is in this leaflet

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

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

How Abecma works 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.

You should not be given Abecma

• 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.

Warnings and precautions Before you are given Abecma you should tell your doctor if

• you have any lung or heart problems.
• 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 being given Abecma.

Tests and checks 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.

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

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

Medicines that affect your immune system 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.

Vaccinations 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. 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 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.

Driving and using machines 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).

Abecma contains sodium, potassium and dimethly sulfoxide (DMSO) 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.

Giving blood to make Abecma from your white blood cells

• 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.

Other medicines you will be given before Abecma

• A few days before you receive Abecma, you will be given a short course of chemotherapy. This is to clear away your existing white blood cells.
• 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.

After Abecma is given

• 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.

If you miss an appointment Call your doctor or the treatment centre as soon as possible to make another appointment.

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 Abecma. They usually happen in the first 8 weeks after the infusion, but can also develop later:

• 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.
• 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), shaking or weakness with loss of movement on one side of the body. Symptoms of parkinsonism, such as tremor, slow movements and stiffness.
• 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.

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

Other possible side effects

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
• 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
• difficulty sleeping
• 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.

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

The following information is intended for doctors only.

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 cassette label and infusion bag label after EXP .

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.

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

This medicine contains genetically modified human blood cells. Local guidelines on handling of waste of human-derived material should be followed for unused medicine or waste material.

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 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 .

What Abecma looks like and contents of the pack 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.

Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG Plaza Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland

Manufacturer Celgene Distribution B.V. Orteliuslaan 13528 BD Utrecht Netherlands

This leaflet was last revised in

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: