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Abecma
Idecabtagene Vicleucel
$648910.00
1
BrandBranded medicine· By Bristol Myers Squibb
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FDA boxed warningCytokine release syndrome, neurologic toxicities, hlh/mas, prolonged cytopenia, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids
Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA.
About Abecma
Overview
Abecma (idecabtagene vicleucel) is a treatment made from a patient’s own T cells, which are genetically modified. It treats adults with multiple myeloma that has returned or has not responded to treatment after at least two previous lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. The modified T cells recognise a protein called BCMA on normal and cancerous plasma cells and become activated to kill cells carrying this protein.
What it treats
Relapsed or refractory multiple myeloma in adults after two or more prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
Safety information
Side effects
Common side effects of Abecma include fever, cytokine release syndrome (CRS, an inflammatory immune reaction), low antibody levels, infections, muscle or joint pain, tiredness, fever with low neutrophil counts, low blood pressure, fast heartbeat, diarrhoea, nausea, headache, chills, upper respiratory tract infections, changes in brain function, swelling and shortness of breath. Severe decreases in white blood cells, neutrophils, lymphocytes, platelets and haemoglobin are also common. Serious risks include early death, CRS, neurological problems, and severe immune-system reactions called haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS). Other serious risks include allergic reactions during infusion, infections, prolonged low blood cell counts and low antibody levels. Secondary cancers, including T-cell cancers, have occurred after treatment with therapies including Abecma. Contact your doctor promptly if you develop signs of infection, changes in brain function, breathing difficulties or a suspected allergic reaction. Blood counts need monitoring before and after treatment, and antibody levels also need monitoring. Your doctor may consider antibody replacement treatment.
FDA boxed warning
Cytokine release syndrome, neurologic toxicities, hlh/mas, prolonged cytopenia, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids
Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no contraindications for Abecma. Caution and monitoring are required for allergic reactions during infusion, infections, prolonged severe low blood cell counts, and low immunoglobulin levels. Blood counts should be checked before and after infusion. Infections should be treated as appropriate, and immunoglobulin replacement therapy may be considered. Secondary cancers, including T-cell cancers, have occurred after treatment with genetically modified T-cell therapies, including Abecma. If a secondary cancer develops after treatment, contact Bristol-Myers Squibb at 1-888-805-4555.
Interactions
Abecma may cause false-positive results with some HIV nucleic acid tests because HIV and the lentivirus used to make Abecma share short stretches of genetic material. Tell your doctor you have received Abecma if you are having an HIV test.
Using Abecma
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label ABECMA (IDECABTAGENE VICLEUCEL) SUSPENSION [CELGENE CORPORATION] (DailyMed, retrieved 19 September 2026).
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