Abecma (idecabtagene vicleucel)

Abecma is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

The US prescribing information does not list any formal contraindications. Abecma must not be administered to patients with active infection or inflammatory disorders before infusion, as specified in the warnings and precautions.

Common adverse reactions include cytokine release syndrome (CRS), fever, hypogammaglobulinemia, infections, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infections, encephalopathy, edema, dyspnea, and viral infections. Serious or potentially life-threatening complications include severe CRS, neurologic toxicity, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged cytopenias, serious infections, and secondary T-cell malignancies. Laboratory abnormalities may include decreased white blood cell, neutrophil, lymphocyte, and platelet counts, as well as decreased hemoglobin.

Abecma can cause life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients closely for fever, hypotension, hypoxia, altered mental status, seizures, and other neurologic symptoms. Monitor blood counts and signs of infection, prolonged cytopenias, hypogammaglobulinemia, and secondary malignancies. Assess hypersensitivity risks and pregnancy status where applicable. Treatment must be administered in a specialized healthcare setting with appropriate emergency management facilities. Tocilizumab must be available before infusion. Patients should be monitored closely following treatment according to the official prescribing information.

The recommended dose is 300 to 510 × 10⁶ CAR-positive T cells as a single intravenous infusion, based on the patient-specific product dose. Administer lymphodepleting chemotherapy with cyclophosphamide and fludarabine before infusion according to the official prescribing information. Premedicate with acetaminophen and an H1-antihistamine. Do not use a leukodepleting filter. The product is for autologous use only and must be administered intravenously. Treatment, preparation, and monitoring must be directed by qualified healthcare professionals experienced in CAR T-cell therapy.

Formal drug interaction studies have not been established. Concomitant medications that suppress immune function may affect the activity of Abecma. Systemic corticosteroids should generally be avoided as prophylactic medication before infusion unless clinically indicated, because they may interfere with CAR T-cell activity. Corticosteroids may be required to manage severe treatment-related toxicities. Cyclophosphamide and fludarabine are used as the required lymphodepleting chemotherapy regimen before infusion. Review all concomitant medications with the treating oncology team.

1. DailyMed, US National Library of Medicine. ABECMA (idecabtagene vicleucel) Prescribing Information.