Learn how ABECMA is made
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How your ABECMA (idecabtagene vicleucel) is made: keeping your cells in good hands.
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At Bristol Myers Squibb, we’re dedicated to helping you at every step of your multiple myeloma, or MM, journey, so you can be confident when making important treatment decisions.
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If you have relapsed or refractory multiple myeloma, one treatment you may be considering is ABECMA, a CAR T cell therapy.
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In fact, ABECMA is the first CAR T cell therapy for MM, and this kind of therapy may be unlike anything you’ve received before.
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ABECMA is made from your own immune cells that are reprogrammed to fight your MM. Your dose of ABECMA is made specifically for you.
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The process of creating your dose of ABECMA takes multiple steps and throughout the process, your cells are passed to different team members, like passing a baton in a race.
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Every step of the way, rest assured that your cells are in good hands. All manufacturing team members go through months of training, and they are experts at what they do.
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Despite working on different parts of the process, we are all united by a common goal giving you the best chance to change your MM story with ABECMA.
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And that story starts with you.
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After your doctor has determined that ABECMA is right for you, they will secure a reservation to ensure that the team is ready and available to create your personalized dose of ABECMA.
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When it’s time for your reservation, your blood is collected through a process called apheresis. During apheresis, only certain cells, called white blood cells, are taken to create ABECMA. Other parts of your blood are returned back into your body.
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Next, your cells are shipped to our state-of-the art, specialized manufacturing laboratory.
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Your cells travel to the lab in refrigerated containers with temperature tracking to ensure they stay viable. We also track the GPS location to make sure they get to their destination.
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Your cells are logged in an electronic system with a unique code that’s specific to you. We check the code throughout the entire process to make sure only your cells get back to you. Your doctor and nurse will also use this code to keep track of your cells.
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Within a few days, your cells will arrive at the manufacturing laboratory. This lab is strictly regulated and constantly monitored to keep the environment clean and your cells safe.
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Although everyone’s cells are different, the process of making ABECMA is the same. We follow a detailed recipe to keep each step consistent, so you can have confidence that your dose of ABECMA was made correctly.
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To start the process, we separate out specific white blood cells, called T cells. T cells are your body’s immune cells that have the natural ability to kill abnormal cells, including cancer cells.
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We then reprogram your T cells by adding hooks called chimeric antigen receptors, or CARs. This creates your very own dose of ABECMA.
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These hooks can specifically attach to BCMA, a target found on nearly all myeloma cells. This can help your CAR T cells find and destroy myeloma cells.
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We let them multiply until they reach the recommended dose of between 300 and 460 million cells.
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Your dose is then divided across one or more infusion bags—the very same bags you will see on the day of your ABECMA infusion.
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Some of the cells are handed off for quality checks, a critical part of the process. There are multiple steps to ensure the strength and purity of your cells.
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Your cells must pass multiple tests before they can be returned to you, so you can be confident that your dose of ABECMA has the best chance at fighting your MM.
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Your ABECMA dose is then securely shipped to your care team at the CAR T cell therapy treatment center.
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When your dose of ABECMA arrives, the baton is passed back to you and your care team, and your treatment can begin
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You will receive your dose of ABECMA with a one-time infusion and your CAR T cells can start fighting your MM.
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It can take several weeks to create ABECMA; every patient’s cells are different and process times may vary.
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While you’re waiting, rest assured that we’re hard at work making your dose of ABECMA, and taking care to ensure your cells are in good hands.
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You can learn more about what to expect from ABECMA at ABECMA.com. ABECMA, also known as idecabtagene vicleucel, is a prescription medicine used to treat adults with relapsed or refractory multiple myeloma (MM), when: you have tried two or more kinds of treatments that have not worked or have stopped working, and you have received at least one therapy from each of these drug classes: an immunomodulatory agent, a proteasome inhibitor, an anti-CD38 antibody.
WARNING: RISK OF SERIOUS SIDE EFFECTS
ABECMA may cause side effects that are life-threatening and can lead to death, including risk of cytokine release syndrome, also called CRS, neurologic toxicity, infections, low blood cell counts, also called cytopenia, and certain types of blood cancers.
Call your healthcare provider or get emergency help right away if you experience any of the following symptoms: trouble breathing, fever (100.4°F or 38°C or higher), chills or shivering, confusion, feeling dizzy or lightheaded, shaking or twitching (tremor), fast or irregular heartbeat, feeling severely tired or weak, severe nausea, vomiting, or diarrhea.
Because of the risk of serious side effects, your healthcare provider will give you an ABECMA Patient Wallet Card that describes symptoms to look out for that require emergency medical care right away. It's important that you tell your healthcare providers that you have received ABECMA and to show them your ABECMA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
How will I receive ABECMA?
ABECMA is a CAR (chimeric antigen receptor) T-cell therapy. It is a prescription medicine made using your own white blood cells. These white blood cells have been changed (genetically modified) to find and attack your multiple myeloma cells. ABECMA is given as an intravenous (IV) infusion.
Before receiving your ABECMA infusion: Your blood cells will be collected by a process called leukapheresis, sometimes called apheresis.
Your blood cells will be sent to a manufacturing site to make your ABECMA. Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. Your healthcare provider will give you 3 days of chemotherapy to prepare your body before receiving your ABECMA treatment.
On the day of your ABECMA infusion: you will receive ABECMA through a tube (catheter) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. Each infusion bag usually takes up to 30 minutes.
After receiving your ABECMA infusion:
For at least 1 week (7 days) after receiving ABECMA, you will stay at the facility where you received your treatment and be monitored daily. For 2 weeks after receiving ABECMA, you should plan to stay close (within 2 hours) to the facility where you received your treatment. During this time, your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
What should I avoid after receiving ABECMA?
Do not drive for at least 2 weeks after you get ABECMA. Do not donate blood, organs, tissues, or cells for transplantation.
What are the possible or reasonably likely side effects of ABECMA?
Serious side effects. ABECMA can increase the risk of serious side effects. A serious side effect is a side effect that is severe or life-threatening and can lead to death. The serious side effects of ABECMA include, but are not limited to:
Early deaths. In a clinical study comparing ABECMA to standard treatments, a higher proportion of people died in the first 9 months from when they were assigned to receive ABECMA compared to people assigned to receive standard treatments. The higher rate of early death was seen before people received ABECMA, and the main reason was that their multiple myeloma had gotten worse. There was also an increase in the rate of death from side effects after receiving ABECMA.
Cytokine release syndrome, also called CRS. ABECMA can increase the risk of CRS, a very common side effect which can be severe or fatal. CRS happens when the immune system responds to an infection or a drug more aggressively than it should. Symptoms to look out for include: fever (100.4°F/38°C or higher), trouble breathing, dizziness or lightheadedness, nausea, headache, fast heartbeat, low blood pressure, feeling tired or weak.
Infections. ABECMA can increase the risk of life-threatening infections that may lead to death. Symptoms to look out for include: fever (100.4°F/38°C or higher), chills, any other signs or symptoms of an infection.
Low blood cell counts, also known as cytopenia. ABECMA can lower the number of one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired, and could increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your blood to check for this. Symptoms to look out for include: fever (100.4°F/38°C or higher), feeling weak or tired, bruising, bleeding.
Other (secondary) blood cancers. ABECMA may increase your risk of getting certain types of cancers, including certain types of blood cancers. You may hear your healthcare provider call these “secondary hematological malignancies.” Your healthcare provider should monitor you for any signs of secondary cancers.
ABECMA may cause a false-positive HIV (Human Immunodeficiency Virus) test result by some commercial tests.
Call your healthcare provider right away if you have any of these symptoms after receiving ABECMA. Remember to bring and show your ABECMA Patient Wallet Card to any healthcare provider who treats you.
Most common side effects
The most common side effects of ABECMA include: feeling tired or weak, fever (100.4°F/38°C or higher), chills or shivering, severe nausea or diarrhea, decreased appetite, headache, dizziness or lightheadedness, confusion, trouble speaking or slurred speech, cough, trouble breathing, fast or irregular heartbeat.
These are not all the possible side effects of ABECMA.
Talk to your healthcare team for medical advice about side effects. You are encouraged to report side effects to Bristol Myers Squibb at ABECMA.com or by calling 1-888-805-4555, or to the FDA by calling 1-800-FDA-1088.
For more information, please see the U.S. Full Prescribing Information, including Boxed WARNINGS, and Medication Guide for ABECMA at ABECMA.com. Talk to your healthcare provider for more information about this medication.