Abecma - patient leaflet, side effects, dosage

Patient leaflet - Abecma

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Abecma 260 – 500 × 10 cells dispersion for infusion

idecabtagene vicleucel (CAR+ viable T cells)

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
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 have any further questions, ask your doctor or nurse.
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.

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

1. What Abecma is and what it is used for

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.

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.

3. How Abecma is given

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.

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 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.

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 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 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.

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 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 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Manufacturer

Celgene Distribution B.V.

Orteliuslaan 1000

3528 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:. There are also links to other websites about rare diseases and treatments.

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.

Precautions to be taken before handling or administering the medicinal product

Abecma should be transported within the treatment centre in closed, break-proof, leak-proof

containers.

This medicinal product contains human blood cells. Healthcare professionals handling Abecma

should take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

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).
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.
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 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.

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.
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 clumps of cellular material. If visible cell clumps remain, continue to gently mix the contents of the bag. Small clumps of cellular material should disperse with gentle manual mixing. Do not wash, spin down and/or resuspend Abecma in new media prior to infusion.

Abecma administration

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.

Ensure that tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
Central venous access may be utilised for the infusion of Abecma and is encouraged in patients

with poor peripheral access.

Confirm the patient’s identity matches the patient identifiers on the Abecma infusion bag.
Prime the tubing of the infusion set with sodium chloride 9 mg/mL (0.9%) solution for injection

prior to infusion.

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 with sodium chloride

9 mg/mL (0.9%) solution for injection at the same infusion rate to ensure all product is delivered.

Follow the same procedure for all subsequent infusion bags for the identified patient.

Disposal of Abecma

Unused medicinal product and all material that has been in contact with Abecma (solid and

liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local guidelines on handling of human-derived material.

Accidental exposure

In case of accidental exposure local guidelines on handling of human-derived material should be followed. Work surfaces and materials which have potentially been in contact with Abecma must be decontaminated with appropriate disinfectant.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

OTHER SPECIAL WARNING(S), IF NECESSARY

For autologous use only.

tlso contains: CryoStor CS10, sodium chloride, sodium gluconate, sodium acetate trihydrate,

potassium chloride, magnesium chloride, water for injections. See leaflet for further information

PHARMACEUTICAL FORM AND CONTENTS

Dispersion for infusion 10–30 mL per bag 30–70 mL per bag 55–100 mL per bag

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Do not irradiate.

Intravenous use.

Gently mix the contents of the bag while thawing.

Do NOT use a leukodepleting filter.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

Justification for not including Braille accepted.

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

OTHER SPECIAL WARNING(S), IF NECESSARY

SAVE THIS DOCUMENT AND HAVE IT AVAILABLE WHEN PREPARING FOR ADMINISTRATION OF ABECMA.

For autologous use only.

SPECIAL STORAGE CONDITIONS

Not applicable.

EU/1/21/1539/001

What you need to know before you are given Abecma

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.