Abecma (idecabtagene vicleucel) is an immunotherapy used to treat multiple myeloma. Specifically, it's known as chimeric antigen receptor (CAR) T-cell therapy, or CAR-T therapy. This treatment involves taking T-cells from your own body, programming them to better find cancer cells, then infusing them back into the body to fight cancer. While Abecma (idecabtagene vicleucel) is given as a one-time infusion, the entire treatment process (including preparation and recovery) can take over a month. Abecma (idecabtagene vicleucel) might cause serious side effects such as cytokine release syndrome (CRS), infection, and nervous system problems.
Your immune system can not only help fight off infections, but certain immune cells (T-cells) can also fight cancer. Sometimes, cancer cells try to hide from the T-cells. So in order for T-cells to work best to fight cancer, they need to tell the difference between healthy and cancer cells.
Abecma (idecabtagene vicleucel) is a type of immunotherapy, also called CAR-T therapy. During treatment, your T-cells are removed from your body and sent to a lab. There, they’re programmed specifically to find and attack the multiple myeloma cancer cells in your body. Once ready, the T-cells are infused back into your body to destroy cancer cells.
| Common Brands | Abecma |
|---|---|
| Drug Class | CAR-T therapy |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Abecma (idecabtagene vicleucel) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome (CRS) is a common and potentially life-threatening side effect of Abecma (idecabtagene vicleucel). It can happen when small proteins from your immune system, called cytokines, overreact to the Abecma (idecabtagene vicleucel) infusion and cause changes in your body. Most of the time, CRS is mild and symptoms include tiredness, headache, chills, fever, and fast heartbeat. But, CRS can also be serious and cause low blood pressure, trouble breathing, abnormal heart rhythm, and serious liver problems. In severe cases, other serious immune system reactions, such as hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS), can develop. These complications can cause organ failure, dangerously low blood pressure, and are life-threatening.
CRS typically occurs within one day of the Abecma (idecabtagene vicleucel) infusion, and your provider will monitor you for symptoms for up to 4 weeks after your infusion. If you do develop symptoms of CRS, get medical help right away. Typically, you’ll need to go to the hospital for treatment with corticosteroids and a medication called tocilizumab (Actemra) to manage it.
Some people taking Abecma (idecabtagene vicleucel) developed nervous system problems. These problems can be mild, such as tiredness, headache, tremor, and confusion. Or, they can be serious and cause a complication called immune effector cell-associated neurotoxicity syndrome (ICANS), which can lead to seizures and swelling in the brain. Most of the time these symptoms happened within 2 days of Abecma (idecabtagene vicleucel) treatment, but your provider will monitor you for symptoms for at least 4 weeks after. If you have symptoms of nervous system problems, seek medical help right away.
Because Abecma (idecabtagene vicleucel) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems including immune effector-cell associated neurotoxicity syndrome (ICANS), it is only available through a special program called a Risk Evaluation and Mitigation Strategy (REMS). This program requires your provider to complete special training to prescribe Abecma (idecabtagene vicleucel). Additionally, the healthcare facility where you receive treatment must keep certain medications used to manage side effects, such as Actemra (tocilizumab), available in case you need it.
People taking Abecma (idecabtagene vicleucel) have developed serious and life-threatening infections, including bacterial, viral, and fungal infections. Abecma (idecabtagene vicleucel) might cause your white blood cell (WBC) levels to drop, which can raise your risk for getting sick. Your provider will monitor your WBC level with lab tests, and they might prescribe medications, such as antibiotics or antivirals, to help protect you from serious infections.
You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your provider right away if you have any signs or symptoms of infection such as fever, body aches, chills, cough, or low blood pressure.
Abecma (idecabtagene vicleucel) treatment, including the lymphodepleting chemotherapy before T-cell infusion, can lower blood cell counts in your body. This puts you at risk for infections, bleeding, and anemia. Some people’s blood cells stayed lower than normal for 2 months or more.
Your provider will closely monitor your blood cell counts after Abecma (idecabtagene vicleucel) treatment. If your blood cell counts are low, they might recommend red blood cell or platelet transfusions, or a medication called growth factor that can prompt white blood cell growth. Make sure you attend all lab appointments that your provider recommends so that they can keep a close eye on your blood cell counts.
Abecma (idecabtagene vicleucel) might cause allergic reactions, including anaphylaxis. This reaction might be due to a preservative called dimethyl sulfoxide (DMSO), a preservative that’s part of the medication. If you have any symptoms of an allergic reaction during your infusion, such as itching, rash, swelling, or trouble breathing, tell your nurse right away.
Some people taking Abecma (idecabtagene vicleucel) experienced low immunoglobulin levels. Immunoglobulins are proteins that are an important part of your immune system, and help fight infection. When your immunoglobulins are low, this raises your risk for getting sick.
Your provider will monitor your immunoglobulin levels. If they’re too low, you might need to take a medication called intravenous immunoglobulin (IVIG) to replace immunoglobulins in your body.
It’s possible for people taking Abecma (idecabtagene vicleucel) to develop a new cancer. Your provider will monitor you for signs of a new cancer.
Abecma (idecabtagene vicleucel) treatment might cause nervous system changes that can include tiredness, confusion, and seizures. Don’t drive or participate in activities that would be dangerous if you couldn’t focus for 2 months after treatment.
Abecma (idecabtagene vicleucel) is usually given at a qualified treatment center or in a hospital setting. The treatment process takes several stages:
After treatment, you’ll need to stay at or near the qualified treatment center for at least 5 weeks so your provider can monitor your recovery and check for side effects.
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Chimeric antigen T-cell therapy, or CAR-T therapy, is a type of immunotherapy used to treat cancer. This treatment uses cells from your own immune system, called T-cells, to attack and kill cancer cells. There are many different types of CAR-T therapy, and each one programs T-cells to attack proteins specific to the type of cancer you have. Abecma is used to treat multiple myeloma, and so T-cells for this treatment are programmed to attack a protein called B-cell maturation antigen (BCMA). This is because the BCMA protein is found on multiple myeloma cells.
To prepare your body, you’ll typically receive three days of chemotherapy before the Abecma infusion. This is called lymphodepleting chemotherapy or lymphodepletion. The most common chemotherapy medications used for lymphodepletion for Abecma are fludarabine and cyclophosphamide. These medications dampen the activity of other immune cells in your body, so they don’t attack or remove the Abecma cells. This helps make sure the Abecma cells will work better to fight and kill cancer cells.
A Risk Evaluation and Mitigation Strategy (REMS) program is a special program created by the FDA. It’s used for medications that might cause serious side effects, and that, because of those serious side effects, need special monitoring or actions. These requirements help keep people taking the medication as safe as possible.Abecma has a REMS program because it can cause serious nervous system problems and a complication called cytokine release syndrome. Providers who prescribe Abecma must complete training about these side effects to make sure they can safely monitor you.
Cytokine release syndrome (CRS) is a type of immune reaction your body might have after you receive Abecma. This reaction happens when small immune proteins called cytokines overreact to the Abecma infusion and cause changes in your body. In mild cases, symptoms include tiredness, headache, chills, fever, and fast heartbeat. CRS can also be serious and cause low blood pressure, trouble breathing, abnormal heart rhythm, organ failure, and liver problems. CRS typically occurs within one day of the Abecma infusion, and your provider will monitor you for symptoms for up to 4 weeks after your infusion. If you do develop CRS, typically you’ll need to stay in the hospital for treatment with corticosteroids and a medication called Actemra (tocilizumab) to manage it.
Yes, Abecma might cause problems in your nervous system. Sometimes this is referred to as immune effector cell-associated neurotoxicity (ICANS). Symptoms are usually mild, such as tremor, confusion, or difficulty speaking. Most of the time, symptoms get better with treatment with medications, such as corticosteroids. But it’s possible for symptoms to be severe or life threatening, such as swelling in the brain. Your provider will monitor you for signs of nervous system problems after treatment. You should contact your provider right away if you have symptoms while you’re at home. It’s important for your family or caregiver to be aware of the symptoms of nervous system problems, in case you experience confusion or difficulty speaking.
