Abecma 260-500 x 10e6 celulas dispersion para perfusion

Prospect: information for the patient

Abecma 260‑500×106cell dispersion for perfusion

idecabtagén vicleucel (viable lymphocytesT‑CAR+)

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect carefully before this medicine is administered to you, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• Your doctor will give you a patient information leaflet. Read it carefully and follow the instructions it contains.
• Always show the patient information leaflet to your doctor or nurse when you see them or visit a hospital.
• If you experience any type of adverse effect, consult your doctor or nurse, even if it is an adverse effect that does not appear in this prospect. See section4.

What is Abecma

Abecma is a type of medication called “genetically modified cellular therapy”. The active ingredient of the medication is idecabtagen vicleucel, which is produced from its own white blood cells, called lymphocytes T.T.

What is Abecma used for

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

It is administered when previous treatments for their cancer have not worked or the cancer has reappeared.

How Abecma works

Its white blood cells are collected from the blood and genetically modified so that they can target the multiple myeloma cells present in the body.

When Abecma is infused into the blood, the modified white blood cells will attack the multiple myeloma cells.

You should not receive Abecma

• if you are allergic to any of the other components of this medication (listed in section6). If you think you may be allergic, consult your doctor.
• if you are allergic to any of the components of the chemotherapy medications that will be administered to reduce the number of lymphocytes, which are used to prepare your body for treatment with Abecma.

Warnings and precautions

Before receiving Abecma, you must inform your doctor if:

• you have lung or heart problems.
• you have low blood pressure.
• you have received a stem cell transplant in the last 4months.
• you are experiencing symptoms or signs of graft-versus-host disease. This disease occurs when the transplanted cells attack your own body and causes symptoms such as skin rash, nausea, vomiting, diarrhea, and blood in the stool.
• you have an infection. You will receive treatment for the infection before receiving Abecma.

• you notice that your cancer symptoms are getting worse. In the case of multiple myeloma, these may include fever, feeling weak, bone pain, or unexplained weight loss.
• you have had a CMV infection, hepatitis B or C virus, or HIV infection.
• you have been vaccinated in the last 6weeks or plan to receive a vaccine in the coming months.

If you are in any of the above circumstances (or are unsure), consult your doctor before receiving Abecma.

Patients treated with Abecma may develop new types of cancer. Cases have been reported of patients developing cancer, which starts with a type of white blood cells called T lymphocytes, after treatment with Abecma and similar medications. Consult your doctor if you experience any new inflammation of the lymph nodes or changes in the skin, such as new rashes or lumps.

Tests and examinations

Before receiving Abecma, your doctor

• will examine your lungs, heart, and blood pressure.
• will look for signs of infection (any infection will be treated before administering Abecma).
• will check if your cancer is getting worse.
• will perform a test to detect CMV, hepatitis B, hepatitis C, or HIV infection.

After receiving Abecma

• there are severe side effects that you must inform your doctor or nurse immediately and may require immediate medical attention. See “severe side effects” in section4.
• your doctor will perform regular blood tests to monitor your blood cell counts, as the number of blood cells may decrease.
• you must stay near the treatment center where you received Abecma for at least 4weeks. See sections3and4.
• do not donate blood, organs, tissues, or cells for transplantation.

Children and adolescents

Abecma should not be administered to children or adolescents under 18years of age.

Other medications and Abecma

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Medications that affect the immune system

Before receiving Abecma, inform your doctor or nurse if you are taking medications that weaken the immune system, such as corticosteroids. You must do this because these medications may interfere with the effect of Abecma.

For information on the medications you will receive before Abecma, see section3.

Vaccinations

You should not receive certain vaccines, specifically live vaccines:

• in the 6weeks before receiving a short course of chemotherapy (called lymphocyte-reducing chemotherapy) that is administered to prepare your body for Abecma.
• during treatment with Abecma.
• after treatment, while your immune system is recovering.

Consult your doctor if you need to receive a vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before receiving this medication. The effects of Abecma on pregnant women or breastfeeding women are unknown and may be harmful to the fetus or infant.

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

If you have received Abecma, consult your doctor about pregnancy.

Driving and operating machinery

Do not drive, operate machinery, or participate in activities that require you to be alert for at least 8weeks after treatment or until your doctor tells you that you are fully recovered. Abecma may cause drowsiness, confusion, or seizures.

Abecma contains sodium, potassium, and dimethyl sulfoxide (DMSO)

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

This medication contains up to 274mg of potassium per dose, which should be taken into account in the treatment of patients with renal insufficiency or those on low-potassium diets.

If you have not been exposed to DMSO before, you should be closely monitored during the first minutes of the infusion period.

Blood donation to manufacture Abecma from your white blood cells

• Your doctor will draw blood through a vein (catheter) that is inserted into a vein. Some white blood cells will be separated from the blood and the rest of the blood will be returned to your body. This procedure is called “leucaféresis” and may take 3 to 6 hours. You may need to repeat the process.
• Next, your white blood cells will be frozen and sent for the manufacture of Abecma.

Other medications that will be administered before Abecma

• A few days before receiving Abecma, you will be administered a brief cycle of chemotherapy. The goal of this is to eliminate your white blood cells.
• Just before receiving Abecma, you will be administered paracetamol and an antihistamine. The goal of these 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, checking that the patient identification information on the medication labels matches your data.
• Abecma is administered through a vein via a catheter using intravenous infusion.

After Abecma administration

• You must remain near the treatment center where you received Abecma for at least 4 weeks.
• You may be followed up daily at the treatment center for at least 10 days to check if the treatment is working and to attend to any side effects. See sections 2 and 4.
• Do not donate blood, organs, tissues, or cells for transplantation.

Missing an appointment

Call your doctor or the treatment center as soon as possible to reschedule an appointment.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor immediately if you experience any of the following side effects after treatment with Abecma. They usually occur within the first 8 weeks after infusion, but can also appear later:

Very common: can affect more than 1 in 10 people

• fever, chills, difficulty breathing, dizziness, nausea, headache, tachycardia, low blood pressure, or fatigue. They may be symptoms of cytokine release syndrome (CRS) or SLC, a serious and potentially life-threatening condition.
• any sign of infection, such as fever, chills, or shivering, cough, difficulty breathing, rapid breathing, and accelerated pulse.
• extreme fatigue or weakness or difficulty breathing, which may be signs of anemia.
• bleeding or bruising more easily without cause, including nosebleeds or oral or intestinal bleeding, which may be a sign of low platelet counts in the blood.

Common: can affect up to 1 in 10 people

• tremors, weakness with loss of mobility in one side of the body, tremor, slow movements, or stiffness, which may be symptoms of parkinsonism.

Uncommon: can affect up to 1 in 100 people

• confusion, memory problems, difficulty speaking or slow speech, difficulty understanding language, dizziness, disorientation, decreased level of consciousness, or excessive somnolence, loss of consciousness, delirium, seizures, which may be symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS).

Inform your doctor immediately if you experience any of these side effects, as you may need urgent medical treatment.

Other possible side effects

Very common: can affect more than 1 in 10 people

• lack of energy
• high blood pressure
• decreased appetite
• constipation
• swelling of the 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, such as pneumonia or respiratory tract infections, mouth, skin, urinary tract, or blood infections, caused by bacteria, viruses, or fungi
• results in clinical tests showing low levels of antibodies, called immunoglobulins (hypogammaglobulinemia), which are important for fighting infections
• results in clinical tests showing decreased levels of calcium, sodium, magnesium, potassium, phosphate, or albumin, which may cause fatigue, weakness, or muscle cramps or irregular heartbeats
• results in clinical tests showing increased levels of liver enzymes (abnormalities in liver function tests) or increased levels of a protein (C-reactive protein) in the blood, which may indicate inflammation.

Common: can affect up to 1 in 10 people

• severe inflammation due to immune system activation, which could cause severe damage to the body
• muscle pain
• abnormal body movements or discoordination
• irregular or arrhythmic heartbeats
• fluid in the lungs
• low oxygen levels in the blood, which may cause difficulty breathing, confusion, or somnolence.

Rare: can affect up to 1 in 1000 people

• a new type of cancer that begins in a type of white blood cells called T cells (secondary neoplasia of T cells).

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This information is intended for healthcare professionals only.

Do not use this medication after the expiration date appearing on the cartridge label and the infusion bag label after “CAD”.

Preserve and transport in the vapor phase of liquid nitrogen (≤−130°C). Do not thaw the medication until it is ready to use. Do not re-freeze.

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

Composition of Abecma

• The active ingredient is idecabtagene vicleucel. Each infusion bag of Abecma contains a cellular dispersion of idecabtagene vicleucel at a concentration dependent on the batch of autologous modified T cells genetically engineered to express a chimeric antigen receptor for anti-BCMA (T cells CAR positive viable). One or more infusion bags contain a total of 260 to 500 × 10^6 T cells CAR positive viable.
• The other components (excipients) are CryoStor CS10, sodium chloride, sodium gluconate, sodium acetate trihydrate, potassium chloride, magnesium chloride, and water for injection. See section 2, “Abecma contains sodium, potassium, and DMSO”.

This medicine contains genetically modified human blood cells.

Appearance of the product and contents of the pack

Abecma is an incolorous infusion cell dispersion, supplied in one or more infusion bags individually packaged in a metal cartridge. Each bag contains between 10 ml and 100 ml of cell dispersion.

Marketing authorization 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

BMS Netherlands Operations B.V.

Francois Aragostraat 2

2342 DK Oegstgeest

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

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This information is intended solely for healthcare professionals:

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

Precautions to be taken before handling or administering the medicine

• Abecma must be transported within the facility in closed, leak-proof, and break-proof containers.
• This medicine contains human blood cells. Healthcare professionals handling Abecma must take the necessary precautions (wear gloves and eye protection) to avoid the possible transmission of infectious diseases.

Preparation before administration

• Before infusing Abecma, confirm that the patient's identity matches the patient identifiers on the cartridge, infusion bag, and the infusion certificate (RfIC) for Abecma.
• Do not remove the infusion bag from the cartridge if the patient identifier on the specific patient label does not match the patient's identity. In case of discrepancies between the labels and patient identifiers, contact the company immediately.
• If more than one infusion bag is received for treatment, thaw each bag individually. Coordinate the thawing time of Abecma with the infusion. Confirm the start time of the infusion in advance and adjust it to take into account the thawing time so that Abecma is available for infusion when the patient is ready.

Thawing

• Remove the infusion bag from the cartridge and inspect it for any signs of damage to the packaging, such as cracks or breaks, before thawing. If the infusion bag appears to be damaged or leaking, do not infuse and dispose of it according to local guidelines for handling human biological materials.
• Place the infusion bag inside a sterile outer bag.
• Thaw Abecma at approximately 37°C using an authorized thawing device or a water bath until no ice is visible in the infusion bag. Gently mix the contents of the bag to disperse any visible clumps of cellular material. Small clumps of cellular material are normal in Abecma. Do not wash, invert, or resuspend Abecma in a new medium before infusion.

Administration

• DO NOT use a leukodepletion filter.
• Abecma infusion should only be administered by a healthcare professional experienced in treating immunocompromised patients and prepared to manage anaphylaxis cases.
• Ensure that tocilizumab and emergency equipment are available before infusion and during the recovery period. In the exceptional case of tocilizumab unavailability due to a shortage listed on the European Medicines Agency's shortage catalog, ensure that alternative measures are available at the center instead of tocilizumab, to treat SLC.
• A central venous access may be used for Abecma infusion and is recommended in patients with poor peripheral access.
• Before administration, confirm that the patient's identifiers match the information on the infusion bag and accompanying documentation. Also confirm the total number of infusion bags to be administered by comparing it with the patient-specific information on the infusion certificate (RfIC).
• Prime the infusion equipment with a 9 mg/ml sodium chloride injection (0.9%) before infusion. Use an infusion equipment with an in-line filter (or a filter not for leukodepletion with a pore size range of 170 to 260 μm) for thawed medicines.
• Infuse Abecma at the maximum tolerated flow rate using gravity flow within 1 hour from the start of thawing.
• Once the contents of the infusion bag have been infused, flush the line, including the in-line filter, with a 9 mg/ml sodium chloride injection (0.9%) at the same infusion rate to ensure that the maximum number of cells possible are infused into the patient.
• All other infusion bags for the identified patient will be administered following the same procedure.

Measures to be taken in case of accidental exposure

• In case of accidental exposure, follow local guidelines for handling human biological materials. The work surfaces and materials that may have come into contact with Abecma should be decontaminated with an appropriate disinfectant.

Precautions to be taken in the disposal of the medicine

• The unused medicine and all materials that have come into contact with Abecma (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local guidelines for handling human biological materials.