Abecma: detailed information

Package leaflet: Information for the patient

Abecma 260 - 500 x 10 cells dispersion for infusion

idecabtagene vicleucel (viable T cells expressing chimeric antigen receptor, CAR)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
Your doctor will provide you with a patient alert card. Read it carefully and follow the instructions contained therein.
Always show your patient alert card to your doctor or nurse during visits or if you go to hospital.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet

What Abecma is and what it is used for
What you need to know before receiving Abecma
How Abecma is administered
Possible side effects
How to store Abecma
Contents of the pack and other information

1. What Abecma is and what it is used for

What Abecma is
Abecma is a type of medicine called a "genetically modified cellular therapy". The active substance in
the medicine is idecabtagene vicleucel, which is produced from your own white blood cells, known as T cells.
What Abecma is used for
Abecma is used to treat adults with multiple myeloma, a cancer of the bone marrow.
It is administered when previous treatments for the cancer have not worked or the cancer has returned.
How Abecma works
The white blood cells taken from your blood are genetically modified to target myeloma cells present in your body.
When Abecma is infused into the bloodstream, the modified white blood cells destroy the myeloma cells.

2. What you need to know before receiving Abecma

Do not receive Abecma

if you are allergic to any of the other components 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 components of the medicine that will be administered to you for lymphodepleting chemotherapy, used to prepare your body for treatment with Abecma.

Warnings and precautions
Before receiving Abecma, you must inform your doctor if:

you have heart or lung problems;
you have low blood pressure;
you have received a stem cell transplant within the last 4 months;
you have signs or symptoms of graft-versus-host disease. This occurs when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea, and blood in the stool;
you have an infection. The infection will be treated before Abecma is administered to you;
you notice that your tumour symptoms are worsening. In myeloma, these may include fever, feeling weak, bone pain, and unexplained weight loss;
you have had a cytomegalovirus (CMV), hepatitis B or C, or human immunodeficiency virus (HIV) infection;
you have received a vaccination within the past 6 weeks or are planning to receive one in the coming months.

If you fall into any of the above conditions (or if you have any doubts), consult your doctor
before receiving Abecma.
Patients treated with Abecma may develop new types of cancer. Cases have been reported of
patients who, after treatment with Abecma and similar medicines, developed a cancer originating from a type of white blood cells called T cells. Contact your doctor if you develop new swelling of the glands (lymph nodes) or skin changes, such as new nodules or rashes.
Tests and monitoring
Before Abecma is administered to you, your doctor will:

perform an examination of your lungs, heart, and blood pressure;
look for signs of infection; any infection will be treated before Abecma is administered to you;
check whether your tumour is worsening;
verify whether you have a CMV, hepatitis B, hepatitis C, or HIV infection.

After receiving Abecma

There are serious side effects that you must immediately report to your doctor or nurse, which may require emergency medical treatment. See section 4 below, “Serious side effects”.
Your doctor will regularly monitor your blood counts, as the number of blood cells may decrease.
Remain close to the treatment centre where you received 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 must not be administered to children and adolescents under 18 years of age.
Other medicines and Abecma
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Medicines affecting the immune system
Before receiving Abecma, inform your doctor or nurse if you are taking medicines that weaken the immune system, such as corticosteroids. This is because such medicines may interfere with the effect of Abecma.
Refer to section 3 for information about the medicines that will be administered to you before receiving Abecma.
Vaccinations
You must not receive certain vaccines known as live vaccines:

within 6 weeks before undergoing a short course of chemotherapy (called lymphodepleting chemotherapy) to prepare your body to receive Abecma;
during treatment with Abecma;
after treatment while your immune system is recovering.

Consult your doctor if you need any vaccinations.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast milk, consult your doctor before receiving this medicine. This is because the effects of Abecma in pregnant or breastfeeding women are unknown, and this medicine could harm the foetus or the newborn breastfed infant.

If you are pregnant or think you may be pregnant after treatment with Abecma, consult your doctor immediately.
You will be given a pregnancy test before starting treatment. Abecma should only be administered if test results show that you are not pregnant.

Discuss pregnancy with your doctor if you have received Abecma.
Driving and using machines
Avoid driving vehicles, operating machinery, or engaging in activities requiring alertness for at least
8 weeks after treatment or until your doctor confirms your full recovery.
Abecma may cause drowsiness, confusion, or seizures (convulsions).
Abecma contains sodium, potassium, and dimethyl sulfoxide (DMSO)
This medicine contains up to 752 mg of sodium (a main component of table salt) per
dose. This corresponds to 37.6% of the maximum daily recommended dietary intake for an adult.
This medicine contains up to 274 mg of potassium per dose. This should be taken into account in patients with reduced kidney function or those following a low-potassium diet.
If you have not been previously exposed to DMSO, you must be closely monitored during the first minutes of the infusion.

3. How Abecma is administered

Blood collection to produce Abecma from white blood cells

Your doctor will collect your blood using a tube (catheter) inserted into a vein. Some of your white blood cells will be separated from the blood, and the remaining blood will be returned to your body. This procedure is called "leukapheresis" and may take from 3 to 6 hours. The procedure may need to be repeated.
Your white blood cells will then be frozen and sent for the production of Abecma.

Other medicines you will receive before Abecma

A few days before receiving Abecma, you will undergo a short course of chemotherapy. This is to eliminate existing white blood cells.
Shortly before receiving Abecma, you will be given paracetamol and an antihistamine. This is to reduce the risk of infusion reactions and fever.

How Abecma is administered

Your doctor will verify that Abecma has been prepared from your own blood by checking that the patient identification details on the medicine label match your personal information.
Abecma is administered by intravenous infusion (drip) through a small tube inserted into a vein.

After receiving Abecma

Remain near the treatment centre where you received Abecma for at least 4 weeks.
You may be monitored daily at the treatment centre for at least 10 days to check whether the treatment is working and to assist you if you experience any side effects. See sections 2 and 4.
Do not donate blood, organs, tissues, or cells for transplantation.

If you miss an appointment
Contact your doctor or treatment centre as soon as possible to schedule another appointment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Contact your doctor immediately if, after receiving Abecma, you experience any of the following side effects, which usually occur within the first 8 weeks after infusion but may also develop later:
Very common: may affect more than 1 in 10 people

fever, chills, difficulty breathing, dizziness or mild confusion, nausea, headache, rapid heartbeat, low blood pressure, or fatigue: these may be symptoms of cytokine release syndrome (CRS), a serious condition that can be fatal;
any signs of infection, which may include fever, chills or shaking, cough, shortness of breath or rapid breathing, and rapid pulse;
extreme tiredness or weakness, or shortness of breath, which may be signs of low red blood cell levels (anaemia);
increased tendency to bleed or bruise without cause, including nosebleeds or bleeding from the mouth or intestines, which may be a sign of low platelet levels in the blood.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

confusion, memory problems, difficulty speaking or slurred speech, difficulty understanding speech, loss of balance or coordination, disorientation, reduced alertness (reduced level of consciousness), or excessive drowsiness, loss of consciousness, delirium, seizures (convulsive episodes), which could be symptoms of a condition called immune effector cell-associated neurotoxicity syndrome (ICANS).

Contact your doctor immediately if you experience any of the above side effects, as you may require urgent medical treatment.
Other possible side effects
Very common: may affect more than 1 in 10 people

loss of energy
high blood pressure
reduced appetite
constipation
swelling of ankles, arms, legs, and face
joint pain
difficulty sleeping
low white blood cell count (neutrophils, leukocytes, and lymphocytes), which may increase the risk of infection
infections, including lung infection or respiratory tract infections, mouth, skin, urinary tract, or blood infections, which may be of bacterial, viral, or fungal origin
laboratory test results showing low levels of antibodies, called immunoglobulins (hypogammaglobulinaemia), which are important for fighting infections
laboratory test results showing reduced levels of calcium, sodium, magnesium, potassium, phosphate, or albumin, which may cause fatigue, muscle weakness or cramps, or irregular heartbeat
laboratory test results showing increased liver enzymes or elevated C-reactive protein in the blood, which may indicate inflammation.

Common: may affect up to 1 in 10 people

severe inflammation caused by activation of the immune system, which could cause serious damage to the body
muscle pain
abnormal body movements or lack of coordination
irregular or uneven heartbeat
fluid in the lungs
low oxygen levels 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 originating from a type of white blood cells called T cells (malignant secondary neoplasm of T-cell origin).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abecma

The following information is intended for healthcare professionals only.
Do not use this medicinal product after the expiry date stated on the label of the metal container and on the infusion bag label after "Exp".
Store and transport frozen in liquid nitrogen vapour (≤ -130 °C). Do not thaw the product until ready for use. Do not refreeze.
Do not use this medicinal product if the infusion bag is damaged or shows signs of leakage.

6. Package contents and other information

What Abecma contains

The active substance is idecabtagene vicleucel. Each Abecma infusion bag contains idecabtagene vicleucel cellular dispersion at a batch-dependent concentration of genetically modified autologous T cells expressing the anti-BCMA CAR (viable T cells expressing the CAR receptor). One or more infusion bags contain a total of 260–500 x 10^6 viable T cells expressing the CAR receptor.
The other components (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 medicinal product contains genetically modified human blood cells.
Description of the appearance of Abecma and contents of the pack
Abecma is a colourless cellular dispersion for infusion supplied in one or more infusion bags, each individually wrapped in a transparent plastic pouch folded behind the infusion bag, and packed in a metal container. Each bag contains 10 mL to 100 mL of cellular dispersion.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Celgene Distribution B.V.
Orteliuslaan 1000
3528 BD Utrecht
The Netherlands
BMS Netherlands Operations B.V.
Francois Aragostraat 2
2342 DK Oegstgeest
The Netherlands
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Belgique/België/Belgien Lietuva
N.V. Bristol-Myers Squibb Belgium S.A. Swixx Biopharma UAB
Tél/Tel: + 32 2 352 76 11 Tel: + 370 52 369140
[email protected] [email protected]
България Luxembourg/Luxemburg
Swixx Biopharma EOOD N.V. Bristol-Myers Squibb Belgium S.A.
Teл.: + 359 2 4942 480 Tél/Tel: + 32 2 352 76 11
[email protected] [email protected]
Česká republika Magyarország
Bristol-Myers Squibb spol. s r.o. Bristol-Myers Squibb Kft.
Tel: + 420 221 016 111 Tel.: + 36 1 301 9797
[email protected] [email protected]
Danmark Malta
Bristol-Myers Squibb Denmark A.M. Mangion Ltd
Tlf: + 45 45 93 05 06 Tel: + 356 23976333
[email protected] [email protected]
Deutschland Nederland
Bristol-Myers Squibb GmbH & Co. KGaA Bristol-Myers Squibb B.V.
Tel: 0800 0752002 (+ 49 89 121 42 350) Tel: + 31 (0)30 300 2222
[email protected] [email protected]
Eesti Norge
Swixx Biopharma OÜ Bristol-Myers Squibb Norway AS
Tel: + 372 640 1030 Tlf: + 47 67 55 53 50
[email protected] [email protected]
Ελλάδα Österreich
Bristol-Myers Squibb A.E. Bristol-Myers Squibb GesmbH
Τηλ: + 30 210 6074300 Tel: + 43 1 60 14 30
[email protected] [email protected]
España Polska
Bristol-Myers Squibb, S.A. Bristol-Myers Squibb Polska Sp. z o.o.
Tel: + 34 91 456 53 00 Tel.: + 48 22 2606400
[email protected] [email protected]
France Portugal
Bristol-Myers Squibb SAS Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Tél: + 33 (0)1 58 83 84 96 Tel: + 351 21 440 70 00
[email protected] [email protected]
Hrvatska România
Swixx Biopharma d.o.o. Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 385 1 2078 500 Tel: + 40 (0)21 272 16 19
[email protected] [email protected]
Ireland Slovenija
Bristol-Myers Squibb Pharmaceuticals Ltd Swixx Biopharma d.o.o.
Tel: 1 800 749 749 (+ 353 (0)1 483 3625) Tel: + 386 1 2355 100
[email protected] [email protected]
Ísland Slovenská republika
Vistor ehf. Swixx Biopharma s.r.o.
Sími: + 354 535 7000 Tel: + 421 2 20833 600
[email protected] [email protected]
Italia Suomi/Finland
Bristol-Myers Squibb S.r.l. Oy Bristol-Myers Squibb (Finland) Ab
Tel: + 39 06 50 39 61 Puh/Tel: + 358 9 251 21 230
[email protected] [email protected]
Κύπρος Sverige
Bristol-Myers Squibb A.E. Bristol-Myers Squibb Aktiebolag
Τηλ: 800 92666 (+ 30 210 6074300) Tel: + 46 8 704 71 00
[email protected] [email protected]
Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

The following information is intended exclusively for healthcare professionals:

It is important to read the entire content of this procedure before administering Abecma.
Precautions to be taken before handling or administration of the medicinal product

Abecma must be transported within the facility in closed, sealed, and leak-proof or break-resistant containers.
This medicinal product contains human blood cells. Healthcare professionals handling Abecma must take appropriate precautions (wear gloves and protective eyewear) to avoid potential transmission of infectious diseases.

Preparation prior to administration

Prior to infusion of Abecma, patient identity must be confirmed to match the patient identification details on the box(es), infusion bag(s), and the Release for Infusion Certificate (RfIC) of Abecma.
The Abecma infusion bag must not be removed from the box if the patient-specific label information does not match the patient to be treated. In case of any discrepancies between labels and patient identification details, the company must be contacted immediately.
If more than one infusion bag has been received for treatment, thaw each infusion bag one at a time. The timing of Abecma thawing and infusion must be coordinated. The start time of infusion must be confirmed in advance and scheduled so that Abecma is available for infusion when the patient is ready.

Thawing

Remove the Abecma infusion bag from the box and inspect it for any compromise in container integrity, such as breaks or cracks, prior to thawing. If the infusion bag appears damaged or appears to be leaking, do not proceed with infusion and dispose of the bag according to local guidelines for handling waste derived from human material.
Place the infusion bag into a second sterile bag.
Thaw Abecma at approximately 37 °C using an approved thawing device or a water bath until no visible ice remains in the infusion bag. Gently mix the contents of the bag to disperse any visible clumps of cellular material. The presence of small clumps of cellular material in Abecma is expected. Do not wash, centrifuge, or resuspend Abecma in a new medium prior to infusion.
The Abecma infusion bag is wrapped in a transparent plastic covering folded over the back of the infusion bag. Carefully remove the infusion bag from the covering by unfolding the plastic covering on the back to expose the infusion bag. Remove the infusion bag from the covering.

Administration

DO NOT use a leukodepletion filter.
Intravenous infusion of Abecma must be administered only by a healthcare professional experienced in the treatment of immunocompromised patients and trained in the management of anaphylaxis.
Ensure that tocilizumab and emergency equipment are available before infusion and during the recovery period. In the rare event that tocilizumab is unavailable due to a shortage listed in the European Medicines Agency’s list of centrally monitored medicinal products, ensure that adequate local alternative measures to tocilizumab are available to treat CRS.
A central venous access may be used for Abecma infusion, recommended in patients with poor peripheral access.
Prior to administration, confirm that the patient’s identity matches the unique patient information on the Abecma infusion bag and accompanying documentation. Also verify the total number of infusion bags to be administered against the patient-specific information on the Release for Infusion Certificate (RfIC).
Prime the infusion set tubing with 9 mg/mL (0.9%) sodium chloride solution for injection prior to infusion. For thawed products, use an infusion set with an in-line filter (a non-leukodepletion filter with pore size between 170 and 260 μm).
Infuse Abecma via gravity flow within 1 hour of starting the thawing process, as rapidly as possible according to tolerance.
After the entire contents of the infusion bag have been infused, flush the tubing, including the in-line filter, with 9 mg/mL (0.9%) sodium chloride solution for injection at the same infusion rate to ensure that as many cells as possible are delivered to the patient.
Follow the same procedure for all subsequent infusion bags for the identified patient.

Measures to be taken in case of accidental exposure

In case of accidental exposure, follow local guidelines for handling human-derived material. Work surfaces and materials that may have come into contact with Abecma must be decontaminated with an appropriate disinfectant.

Precautions to be taken for disposal of the medicinal product

Unused medicinal product and all materials that have come into contact with Abecma (solid and liquid waste) must be handled and disposed of as potentially infectious waste in accordance with local guidelines for handling human-derived material.