Generic Name: idecabtagene vicleucel; ide-cel
Trade Name: ABECMA®
For which conditions is ABECMA approved for? ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have had four or more prior treatments that include immunotherapy, a proteasome inhibitor and an anti-CD38 monoclonal antibody. The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and or life-threatening side effects including cytokine release syndrome (CRS), neurological toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLM/MAS), or prolonged cytopenia with bleeding and infection. Because of these risks, ABECMA is being approved with a risk evaluation and mitigation strategy (REMS).
What is the mechanism of action? ABECMA is a genetically-modified personalized immune cell therapy; a patient’s own white blood cells are genetically modified to recognize and attack multiple myeloma cells that express a specific protein called B-cell maturation antigen (BCMA). Nearly all multiple myeloma cells express BCMA.
How is ABECMA typically given (administered)? Each dose of ABECMA is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. Your T-cells are collected in a 3-6 hour procedure called leukapheresis and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill multiple myeloma cells that have a specific antigen, BCMA, on the surface. Before you get ABECMA, your healthcare provider may give you chemotherapy for three days to prepare your body. Once the cells are modified, ABECMA is infused.
How are patients typically monitored? Patients will be monitored daily for 7 days after receiving ABECMA and will usually have scheduled meetings with their healthcare provider while for the leukapheresis procedure, chemotherapy, treatment with ABECMA, and follow up after treatment. Typically, blood will be drawn before and after treatment to check levels of blood cells and to monitor for low white blood cell counts and infections. In addition, patients may undergo physical examinations, scans, or other measures to assess side effects and response to therapy. You should plan to stay close to the location where you received your treatment for at least 4 weeks after treatment with ABECMA.
What are the most common side effects of treatment with ABECMA?
- Severe nausea or diarrhea
- Decrease in appetite
- Dizziness or lightheadedness
- Difficulty speaking or slurred speech
- Difficulty breathing
- Fast or irregular heartbeat
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ABECMA works and can cause side effects.
- ABECMA may cause severe or life-threatening side effects and it is important that you call your healthcare provider right away if you experience symptoms of CRS, infection, neurologic toxicities, cytopenia or HLM/MAS. If you seek emergency care, it is important to let your healthcare providers know that you have received ABECMA.
Are there any special precautions patients should be aware of before starting treatment?
- You should plan to stay close to the location where you received your treatment for at least 4 weeks after treatment with ABECMA.
- Do not operate heavy machinery or drive for at least 8 weeks after you receive ABECMA; ABECMA can cause sleepiness, confusion, dizziness and seizures as well as memory problems.
- A false-positive HIV test is possible while being treated with ABECMA.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. ABECMA may cause severe or life-threatening side effects and it is important that you call your healthcare provider right away if you experience:
- Symptoms of CRS: fever, difficulty breathing, dizziness or lightheadedness, nausea, headache, fast heartbeat, low blood pressure or fatigue.
- Symptoms of infection: fever, chills, any sign of an infection
- Symptoms of cytopenia: weakness, tiredness
If you seek emergency care, it is important to let your healthcare providers know that you have received ABECMA.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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