Abecma (idecabtagene vicleucel) is a brand-name cell therapy that’s prescribed for multiple myeloma in certain situations. Abecma is made using cells from your body’s immune system. It’s a CAR T-cell therapy.
Abecma is FDA approved for use in adults to treat multiple myeloma that’s:
- refractory (hasn’t responded to past treatments) or relapsed (came back after being treated in the past), and
- been previously treated with certain types of medications, but they didn’t work or stopped working
Drug details
You’ll find key information about Abecma below.
- Drug class: chimeric antigen receptor (CAR) T-cell therapy, which is a type of immunotherapy
- How it’s given: intravenous infusion
- Generic available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2021
Abecma has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Abecma precautions” section below.
Abecma is a type of immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapies are made using cells from your own immune system. It is a custom-made treatment. It isn’t available in a biosimilar or generic version.
Abecma is a brand-name cell therapy. Its active ingredient is idecabtagene vicleucel, which is made using cells from your body’s immune system. (To learn more about how Abecma is made and given, see the “Abecma dosage” section just below.)
As with all medications, the cost of Abecma can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Drug coupons: You can visit Optum Perks for price estimates of Abecma. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.
Financial and insurance assistance: If you need financial support to pay for Abecma, or if you need help understanding your insurance coverage, help is available.
A program called Cell Therapy 360 is available for Abecma. For more information and to find out if you’re eligible for support, call 888-805-4555 or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Biosimilar version: Abecma is a brand-name cell therapy. Abecma is not available in a generic or biosimilar form.
To learn more about saving money on prescriptions, check out this article.
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Here are answers to some frequently asked questions about Abecma.
How does Abecma work?
Abecma is a type of immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. T-cells are a type of immune system cell.
Similar to other CAR T-cell therapies, Abecma is custom-made using T-cells from your own immune system. The process requires your T-cells to be collected from your blood. The T-cells are sent to a special lab. There, your Abecma treatment is made by genetically modifying your T-cells to add a surface protein called CAR. This genetic modification enhances the T-cells’ ability to detect and destroy certain cells, including multiple myeloma cells.
After you receive the infusion, Abecma works by targeting a protein called B-cell maturation antigen (BCMA). BCMA is found on the surface of most multiple myeloma cells and some healthy blood cells. When Abecma targets BMCA, it activates your immune system to make more CAR T-cells and destroys cells with BCMA on their surfaces.
If you have questions about what to expect with Abecma treatment, talk with your doctor.
How does Abecma compare to Carvykti?
Abecma and Carvykti (ciltacabtagene autoleucel) are both CAR T-cell therapies. Abecma is the first CAR T-cell therapy that the FDA approved for treating relapsed or refractory multiple myeloma in certain situations. It was first approved in 2021. In 2022, Carvykti became the second CAR T-cell therapy approved for this purpose.
At first, Abecma and Carvykti were only approved to treat relapsed or refractory multiple myeloma that’s been previously treated with at least four lines of treatment. Now, as of April 2024, the FDA has approved earlier use of these treatments.
Abecma is now approved for use after trying at least two previous lines of treatment (including certain drug types). And Carvykti is now approved for use after trying at least one line of treatment (also including certain drug types).
This change may allow more people to receive CAR T-cell therapy sooner. While Abecma and Carvykti can be effective for treating multiple myeloma, they also carry serious risks. Talk with your oncologist to determine if CAR T-cell therapy may be an option for you.
What should I avoid after Abecma treatment?
Due to the risk of side effects that may occur after your Abecma infusion, you’ll be required to take certain precautions to help keep you safe. Your doctor will explain all the precautions. Some examples include:
- You should not drive or engage in potentially hazardous activities for at least 8 weeks after your Abecma infusion. This is because Abecma can cause confusion, dizziness, and other neurologic toxicities. (Abecma has a boxed warning about neurologic toxicities. A boxed warning is the most serious warning from the FDA. For details, see the “Abecma precautions” section below.)
- You should not donate blood, cells, tissues, or organs for transplant at any time after Abecma treatment.
- If you can become pregnant, your doctor may recommend continuing to use birth control after Abecma treatment. It isn’t known how long to avoid pregnancy after the treatment. (See the “Things to consider when taking Abecma” section below for details.)
- Plan to stay in the hospital for at least a week after your infusion. You’ll also need to return for frequent monitoring for the next 4 weeks (or longer) after you get out of the hospital, so plan on staying nearby.
During this time, you and your doctor will closely monitor for side effects. This way, any side effects that develop can be promptly managed.
Talk with your doctor or pharmacist to learn more about what to avoid after Abecma treatment.
The Food and Drug Administration (FDA) approves prescription treatments such as Abecma for certain conditions. Abecma may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.
Abecma for relapsed or refractory multiple myeloma
Abecma is a type of immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. It’s FDA approved to treat multiple myeloma (a type of blood cancer) in adults. Specifically, Abecma may be prescribed if the cancer is either:
- relapsed, which means the cancer came back after being treated in the past
- refractory, which means that past treatments didn’t work or stopped working
Abecma is only used after you’ve received at least two lines of treatment for multiple myeloma. And your first-line and second-line treatments must have included certain types of medications. These include:
- an immunomodulator such as lenalidomide (Revlimid)
- a proteasome inhibitor such as carfilzomib (Kyprolis)
- an anti-CD38 monoclonal antibody such as daratumumab (Darzalex)
Abecma may be prescribed for multiple myeloma that is “triple-class refractory.” This means you’ve tried medications from all three of the drug classes listed above, but they didn’t work or stopped working.
For this purpose, Abecma is given after a short-term pretreatment with certain chemotherapy drugs. These include cyclophosphamide and fludarabine. You may also be prescribed other treatments while you are waiting to receive your Abecma treatment, which is custom-made. (To learn more about the Abecma treatment process, see the “Abecma dosage for multiple myeloma” section below.)
To learn more about your condition and other treatment options, visit our cancer hub.
Abecma and children
Abecma is not FDA approved for use in children. It isn’t known if Abecma is safe or effective for treating multiple myeloma (or any other condition) in people younger than 18 years old.
Abecma can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Abecma. These lists do not include all possible side effects.
For more information about the possible side effects of Abecma, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Abecma, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Abecma. To learn about other mild side effects, talk with your doctor or pharmacist, or view Abecma’s prescribing information.
Mild side effects of Abecma can include:
- fever
- muscle pain
- fatigue
- diarrhea
- nausea
- headache
- chills
- mild infection, such as the common cold
- edema (fluid retention)
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects may occur with Abecma. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.
Serious side effects may include:
- severe bacterial, viral, or fungal infections, which may cause symptoms such as:
- fever
- cough
- organ problems (varies with specific infection)
- cytokine release syndrome*
- neurologic toxicities*
- hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)*
- prolonged cytopenias*
- T-cell malignancies*
* Abecma has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Abecma precautions” section below.
ALLERGIC REACTIONFor some people, an Abecma infusion can cause an allergic reaction.
But it’s not clear how often this side effect occurred in the Abecma studies.
In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Abecma or the ingredient dimethyl sulfoxide (DMSO), your doctor may recommend a different treatment instead.
This section describes the Abecma treatment process and how it’s given.
Abecma treatment process
Abecma is made using T-cells, which are cells from your body’s immune system. Each dose of Abecma is custom-made using two basic steps:
- T-cell harvesting: You’ll go through a blood collection procedure called leukapheresis. During this procedure, your T-cells are collected from your blood. This procedure usually takes a few hours.
- CAR T-cell manufacturing: Your T-cells are sent to a special lab. Here, they are genetically modified to add a surface protein called chimeric antigen receptor (CAR). Then, the lab grows millions of these cells, now called CAR T-cells. Next, the cells are washed, made into the Abecma suspension (a liquid mixture), then frozen. Finally, after Abecma is tested to ensure it is sterile (germ-free), the medication gets shipped to your treatment center. The manufacturing process typically takes about 4 weeks.
Before receiving Abecma
Before receiving Abecma, you’ll receive short-term chemotherapy as a pretreatment. This helps prepare your body for Abecma. It includes a 3-day regimen of two chemotherapy drugs, given intravenously: cyclophosphamide and fludarabine.
Your Abecma infusion will likely be scheduled for 2 days after you complete the pretreatment chemotherapy. However, your Abecma treatment may be delayed by up to 7 days if you develop an infection, certain side effects from the chemotherapy, or other health problems.
Up to an hour before you start the Abecma infusion, you’ll be given medications to help prevent side effects. These include acetaminophen (Tylenol) and an antihistamine, such as diphenhydramine (Benadryl).
Receiving Abecma
Abecma comes as a frozen suspension. (A suspension is a mixture that contains solid and liquid components.) A healthcare professional will thaw the suspension, prepare it, and administer it as an intravenous (IV) infusion. It is a single-dose infusion and may take 30 minutes or longer. Abecma is given by a healthcare professional at a hospital (or another healthcare facility) that is certified to provide Abecma treatment.
After the Abecma infusion, you’ll stay in the hospital for at least a week. During this time, healthcare professionals will closely monitor you for side effects. Careful monitoring will continue for at least a month after your Abecma infusion. And you should not drive or engage in activities that may lead to harmful effects for at least 2 months after receiving Abecma. Your doctor will tell you more about what to expect after Abecma treatment.
If you have questions about your Abecma dosage or treatment process, talk with your doctor. Abecma’s manufacturer also describes the whole process in detail on their website.
About receiving Abecma
Below you’ll find information about key dosage issues.
- Length of use: Abecma is a short-term treatment. But the entire treatment process requires a few months of careful planning along with long-term monitoring for side effects.
- Length of time to work: Abecma starts working right away. Your doctor will order tests to check how your body is responding to the treatment. But it may take at least a month before test results show how well the treatment is working. In clinical trials, some people had a complete response within 3 months after receiving Abecma. (With a complete response, your test results show no signs of cancer.)
Abecma may interact with certain vaccines and lab tests. These are shown in the table below.
Interactions with vaccines and lab tests
Lab tests that may interact with Abecma | • HIV tests: a false positive result may occur in people who have received Abecma. |
Vaccines that may interact with Abecma | • Live vaccines, such as chickenpox (Varivax) and measles, mumps, and rubella (MMR): live vaccines before or during the Abecma treatment hasn’t been studied, but it is recommended to avoid live vaccines 6 weeks before starting treatment through the recovery period. |
Abecma is not known to interact with medications, herbs, supplements, foods, or alcohol. The manufacturer did not list these types of interactions in Abecma’s prescribing information.
However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could become available that interact with Abecma.
Before receiving Abecma, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about interactions that may affect you, talk with your doctor or pharmacist.
Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Abecma, talk with your doctor. They can tell you about other medications that may work well for you.
Similar to Abecma, one other CAR T-cell therapy is approved to treat relapsed or refractory multiple myeloma in certain adults. It’s called Carvykti (ciltacabtagene autoleucel).
Other drugs may be used to treat this condition. Examples include:
If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.
Abecma and pregnancy
It’s not known whether Abecma should be used during pregnancy. This treatment hasn’t been studied in pregnant people. But based on how the treatment works in the body, it may cause harm to a fetus.
If you’re able to become pregnant, your doctor will give you a pregnancy test before you receive Abecma treatment. This is done to confirm that you aren’t pregnant before receiving the treatment.
Your doctor may also suggest birth control options to use during and after treatment with Abecma. It isn’t known how long you should continue using birth control after Abecma treatment. This is because it isn’t known how long to avoid pregnancy after the treatment. Your doctor may recommend avoiding pregnancy indefinitely.
If you’re planning to have children in the future, talk with your doctor about this before receiving Abecma. Your doctor can help you consider family planning options and connect you with available resources.
Abecma and birth control
It’s not known if Abecma is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Abecma.
Abecma and breastfeeding
It’s not known whether Abecma should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before planning to receive Abecma treatment.
Abecma treatment comes with several warnings and precautions.
FDA warnings
Abecma has several boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
As with other CAR T-cell therapies, Abecma carries risks of serious side effects, such as CRS and neurologic toxicities (more details just below). As such, Abecma is only available through a special program called the Abecma REMS. (REMS stands for risk evaluation and mitigation strategy.) Due to the requirements of the REMS program, Abecma can only be administered by specially trained healthcare professionals at certified hospitals or treatment centers. To learn more about this, talk with your doctor or visit the Abecma REMS website.
Abecma’s boxed warnings are described below.
Cytokine release syndrome (CRS)
Abecma may cause cytokine release syndrome (CRS). Cytokines are signaling proteins that help the immune system function. CRS is a common side effect of immunotherapy. It occurs when the immune system rapidly releases a large number of cytokines into the blood.
CRS can cause symptoms such as fever, nausea, and headache. In some cases, CRS can cause widespread inflammation in your body, which can be life threatening. Tell your doctor right away if you develop symptoms of CRS during or after your Abecma infusion. Due to the risk of CRS and other serious side effects, you’ll be closely monitored by healthcare professionals during and after your treatment.
Neurologic toxicities
Abecma may cause neurologic toxicities. This is a broad term that refers to side effects that affect the brain and nerves. Certain neurologic toxicities are common with Abecma. These are usually mild, such as headache, dizziness, or trouble with coordination. In rare cases, Abecma may cause serious neurologic toxicities that are severe or life threatening. Examples of these are confusion, seizures, and encephalopathy (brain damage).
Tell your doctor right away if you develop any symptoms of neurologic toxicity during or after your Abecma infusion. Due to the risk of neurologic toxicities and other serious side effects, you’ll be closely monitored by healthcare professionals during and after your treatment.
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
Abecma may cause a rare disorder known as HLH/MAS. With this condition, excessive inflammation occurs throughout your body. Signs and symptoms of HLH/MAS that have occurred with Abecma use include low blood pressure, hypoxia, kidney problems, problems with multiple organs, and low blood cell counts.
Without prompt treatment, HLH/MAS may be fatal. Due to the risk of HLH/MAS and other serious side effects, you’ll be closely monitored by healthcare professionals during and after your treatment.
Prolonged cytopenias
You may experience prolonged cytopenias (long-lasting low blood cell counts) during CAR T-cell therapy. This may occur after the 3-day chemotherapy pretreatment that you’ll receive to prepare your body for the Abecma infusion. Or this may occur following the Abecma infusion.
Having low blood cell counts is associated with anemia, bleeding problems, and an increased risk of infections. Throughout the treatment process, you’ll get blood tests regularly so that your doctor can monitor your blood cell counts. If your blood cell counts become too low, they’ll prescribe treatments or blood transfusions to raise your blood cell counts.
T-cell malignancies
Abecma is used to treat multiple myeloma (a type of blood cancer) in certain people. Rarely, some people have reported developing another type of cancer following Abecma treatment. This includes T-cell malignancies (cancers affecting T-cells, which are a type of immune system cell). Due to this risk, you will have regular follow-up visits with your doctor to monitor for cancers after your Abecma treatment ends.
Other precautions
Before taking Abecma, discuss your health history with your doctor. Abecma may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- active infections or inflammatory disorders
- past or active hepatitis B infection
- previous allergic reaction to Abecma, another CAR T-cell therapy, or the ingredient dimethyl sulfoxide (DMSO)
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Abecma, see the “Abecma side effects” section above.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.