Indications and Usage

Idecabtagene vicleuce is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Side effects needing medical attention 

The most common adverse reactions include Cytokine Release Syndrome, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia (not enough gamma globulins are produced in the blood, increasing risk of infection), diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy damage or disease that affects the brain), edema (swelling caused by excess fluid trapped in your body's tissues), fever, cough, headache, and decreased appetite. The most common laboratory adverse reactions include neutropenia, leukopenia, lymphopenia, thrombocytopenia, and anemia.

WARNING:

See full prescribing information for complete boxed warning.

• 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.
• Abecma is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Abecma REMS.

For information on how to manage the costs of drug therapy, please see Financial Support, or to speak with an Information Specialist, call (800) 955-4572.