Pronunciation: uh-BEK-muh
Generic name:  idecabtagene vicleucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 25, 2024.

What is Abecma?

Abecma is a CAR T cell therapy used to treat relapsed or refractory multiple myeloma to help patients live longer without cancer progressing or passing away. Abecma infusion is made from your white blood cells, which are changed so that they can recognize and kill multiple myeloma cancer cells. It is given as a one-time infusion after the process of making your personal infusion.

Abecma FDA approval was granted on March 26, 2021, for adult patients who have relapsed or refractory multiple myeloma and have tried two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody.  Abecma approval was based on positive results from KarMMa Pivotal Trial that showed 72% idecabtagene vicleucel treated patients had a response that was a partial response (19%), very good partial response (25%), or stringent complete response (28%). 

Abecma mechanism of action (MOA) is as a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell immunotherapy.

How does Abecma work?

Abecma (idecabtagene vicleucel) is a medicine made from your own white blood cells, which are genetically modified so that they can recognize and attack your multiple myeloma cells. Abecma Car T therapy works as your T cells (a type of white blood cell) are changed to recognize proteins on the outside MM cancer cells so that they can attack the cancer cells. A more detailed explanation of how it works is:

• Your T cells are a type of white blood cell that is part of your immune system that can attack foreign substances in your body.
• On the outside of the multiple myeloma cells are proteins called B-cell maturation antigen (BCMA).
• Normally, T cells do not recognize MM cells, so do not attack and kill them.
• Your T cells (type of white blood cell) are collected and sent to the manufacturing center where they add to the T cell a special receptor called CAR (chimeric antigen receptor) that is designed to bind to certain proteins in cancer cells.
• Your T Cells will now be able to recognize the BCMA protein on the MM cells and kill the cancer cells.
• These changed T cells, called chimeric antigen receptor T cells (CAR T cells), are then grown in large numbers in the laboratory and then given as a one-time Abecma infusion to the MM cancer patient.

BCMA = B-cell maturation antigen. CAR-T = chimeric antigen receptor-T cell.

How will I receive Abecma?

Abecma is made from your own white blood cells, so your blood will be collected by a process called "leukapheresis" (LOO-kuh-feh-REE-sis). This is when they take blood from your bloodstream and separate white blood cells from the rest of your blood, which they return to the bloodstream.

Your white blood cells will be sent to a manufacturing center to make your infusion, which usually takes about 4 weeks, but the time may vary.

Before you have your infusion, you will be given chemotherapy for 3 days to prepare your body.

You are usually given Abecma 2 days after completion of chemotherapy.

Abecma is given as an intravenous infusion through a catheter (tube) placed into your vein. Your dose may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.

Approximately 30 to 60 minutes before your infusion, you will be given an antihistamine and acetaminophen.

You will be monitored at the certified healthcare facility, where you will receive your treatment daily for at least 7 days after the infusion.

You should plan to stay within 2 hours of this location for at least 4 weeks after getting Abecma. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.

Your infusion may be delayed up to 7 days if you have any of the following conditions:

• unresolved serious adverse events (especially pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies,
• active infections, or inflammatory disorders.

Related/similar drugs

Carvykti, Darzalex, Tecvayli, Revlimid, Velcade, Pomalyst, Kyprolis, Ninlaro

Abecma side effects

Common Abecma side effects may include:

• cytokine release syndrome (confusion, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired);
• headache, dizziness;
• problems with speech;
• low blood cell counts;
• fever, chills, tiredness, or other signs of infection;
• decreased appetite, severe nausea or diarrhea;
• pain in your bones, joints, or muscles;
• swelling anywhere in your body; or
• cold symptoms such as stuffy nose, sneezing, sore throat, cough.

Serious Abecma side effects:

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also, tell your caregivers or seek emergency medical attention if you have signs of nerve problems, blood disorders, or infection. Symptoms may include problems with speech, problems with thinking or memory, confusion, fatigue, fever, swelling, or a seizure.

Call your doctor at once if you have:

• headaches, dizziness, drowsiness;
• problems with thinking or memory;
• trouble speaking or understanding what is said to you;
• tremors, anxiety, sleep problems;
• seizure;
• right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well; or
• low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abecma can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or light-headedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any of these other symptoms.

Abecma can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection. It may also lower one or more types of blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired or increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your
blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.

Abecma may increase your risk of getting cancer including certain types of blood cancers, called T-cell malignancies. Your healthcare provider should monitor you for these.

Abecma may also cause life-threatening nerve problems, blood disorders, or other life-threatening reactions. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, seizures, fatigue, shortness of breath, or chest pain.

Having Abecma in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests.

It is important that you tell your healthcare providers that you have received Abecma and to show them your Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

Before taking this medicine

Tell your doctor if you have ever had:

• an active infection or inflammation;
• hepatitis B;
• cytomegalovirus; or
• if you have received a vaccine in the past 6 weeks.

Pregnancy

This medicine is not recommended for women who are pregnant, and pregnancy after Abecma infusion should be discussed with the treating physician. Women may need to take a pregnancy test before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with Abecma and chemotherapy.

Assess immunoglobulin levels in newborns of mothers treated with this infusion. If you receive the infusion during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

What should I avoid while using Abecma?

Abecma can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are have your infusion.

Vaccination with live virus vaccines is not recommended for at least 6 weeks before the start of lymphodepleting chemotherapy, during Abecma treatment, and until immune recovery following your infusion.

Do not donate blood, an organ, or any tissues or cells.

Abecma REMS

Abecma is only available through a restricted program called the Abecma REMS (Risk Evaluation and Mitigation Strategy) program designed to manage the risk of serious side effects. The Abecma REMS program aims to reduce  the risks of cytokine release syndrome (CRS) and neurologic toxicities. This infusion can only be administered at a REMS-certified healthcare facility that is specially certified and has on-site, immediate access to treatments (tocilizumab) and facilities that may be required.

What other drugs will affect Abecma?

Other drugs may interact with Abecma, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

• Store Abecma frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C).
• Thaw Abecma prior to the infusion, according to the Prescribing Information.

Ingredients

Abecma is supplied in one or more infusion bag(s) containing a frozen suspension of genetically modified autologous T cells in 5% DMSO.

Abecma is made specifically for each individual patient with their own white blood cells. Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt.

Abecma Company

Abecma manufacturer Celgene Corporation, a Bristol-Myers Squibb Company, 556 Morris Avenue, Summit, NJ 07901.

Marketed by: Celgene Corporation, a Bristol-Myers Squibb Company (Summit, NJ 07901), and bluebird bio, Inc. (Cambridge, MA 02142).

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Further information

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