Abecma
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.
What is Abecma (idecabtagene vicleucel)?
What is Abecma (idecabtagene vicleucel) used for?
- Advanced multiple myeloma in adults (after at least two or more prior therapies)
How Abecma (idecabtagene vicleucel) works
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.
Drug facts
More on Abecma (idecabtagene vicleucel) essentials
Side effects of Abecma (idecabtagene vicleucel)
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.
Common Side Effects
- Lower blood cell counts (up to 96%)
- Cytokine release syndrome (85%)
- Infection (51%)
- Tiredness (45%)
- Lower blood phosphate levels (45%)
- Muscle pain (45%)
- Lower immunoglobulin levels (41%)
- Diarrhea (35%)
- Nausea (29%)
- Nervous system problems (26%)
- Fever (25%)
- Swelling (25%)
- Headache (23%)
- Cough (23%)
- Lower appetite (22%)
Less Common Side Effects
- Faster heartbeat
- Constipation
- Vomiting
- Chills
- Dizziness
- Rash
- Pain in the mouth
- Dry eyes, dry mouth
- Trouble catching your breath
- Trouble sleeping
- Anxiety
- Weight loss
- Movement problems
Abecma (idecabtagene vicleucel) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome: Fever, trouble breathing, chills, low blood pressure, changes in heart rhythm, headache
- Serious nervous system problems: headache, confusion, difficulty speaking, difficulty writing, seizures
- Infection: fever, body aches, fast heartbeat, chills
- Bleeding (from low platelet levels): nosebleeds, blood in urine, blood in stool, unexplained bruising
The following Abecma (idecabtagene vicleucel) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Loss of appetite
- Muscle pain
- Nausea
- Swelling of the ankles, hands, or feet
Pros and cons of Abecma (idecabtagene vicleucel)
Pros
- Works in a targeted, more specific way than traditional chemotherapy
- Recommended treatment for certain people with multiple myeloma
- Offers a treatment option in people even after they’ve tried 2 or more previous therapies
Cons
- Can cause a serious reaction called cytokine release syndrome
- Treatment requires a multi-step process that takes about a month to complete
- No generic options available
Pharmacist tips for Abecma (idecabtagene vicleucel)
- Typically, you’ll be required to stay within a certain proximity to your provider’s office or hospital for at least 4 weeks after Abecma (idecabtagene vicleucel) treatment. This is to make sure you can receive prompt treatment if you have any side effects.
- If you develop a temperature of 100.4 Fahrenheit or higher, seek medical help right away. This means you have a fever. A fever with Abecma (idecabtagene vicleucel) can be serious, because it can mean you have an infection or it can be an early sign of cytokine release syndrome (CRS).
- Some people taking Abecma (idecabtagene vicleucel) developed serious infections. You can help prevent infection by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them.
- If you have multiple myeloma or take certain medications like Abecma (idecabtagene vicleucel), your immune system might not work as well. Your provider might recommend you take antiviral or antibiotic medications to help prevent certain infections.
- Abecma (idecabtagene vicleucel) can cause tiredness and nervous system problems. Because of these risks, you shouldn’t drive or handle any type of dangerous machine for 2 months after your treatment. Make sure you have family, friends, or a caregiver to help drive you to and from appointments.
- Even though it’s usually mild, you might experience some nausea during lymphodepleting chemotherapy and Abecma (idecabtagene vicleucel) treatment. Ask your provider about antiemetic medications such as ondansetron (Zofran) or prochlorperazine (Compazine) to help manage nausea.
- We don’t know if it’s safe to take live virus vaccines with Abecma (idecabtagene vicleucel). Don’t get live virus vaccines without first talking to your provider.
Common questions about Abecma (idecabtagene vicleucel)
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 (idecabtagene vicleucel) 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 (idecabtagene vicleucel) infusion. This is called lymphodepleting chemotherapy or lymphodepletion. The most common chemotherapy medications used for lymphodepletion for Abecma (idecabtagene vicleucel) 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 (idecabtagene vicleucel) cells. This helps make sure the Abecma (idecabtagene vicleucel) 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 (idecabtagene vicleucel) has a REMS program because it can cause serious nervous system problems and a complication called cytokine release syndrome. Providers who prescribe Abecma (idecabtagene vicleucel) 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 (idecabtagene vicleucel). This reaction happens when small immune proteins called cytokines overreact to the Abecma (idecabtagene vicleucel) 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 (idecabtagene vicleucel) 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 (idecabtagene vicleucel) 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.
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Risks and warnings for Abecma (idecabtagene vicleucel)
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
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.
Nervous system problems
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.
REMS program
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.
Infection
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.
Lower blood cell counts
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.
Allergic reactions
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.
Low immunoglobulin levels
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.
Possible risk for new cancers
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.
Risks driving and using machines
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) dosage
Typical dosage for Abecma (idecabtagene vicleucel)
Abecma (idecabtagene vicleucel) is usually given at a qualified treatment center or in a hospital setting. The treatment process takes several stages:
- Blood collection: Your immune cells are collected from your body. The T cells are separated, while the rest of your immune cells are infused back into your body. This process takes about 4-6 hours.
- Making Abecma: Your T cells are sent to a lab and made into Abecma that’s specific for you. This step takes about 1 month.
- Pre-treatment with chemotherapy: To prepare your body to receive Abecma, your provider will prescribe 3 days of chemotherapy, typically cyclophosphamide and fludarabine.
- Receiving Abecma: Two days after chemotherapy, your provider will infuse Abecma into the veins as a one-time infusion over 30 minutes.
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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