Leukemias, lymphomas, and other hematologic cancers:
Indications for ABECMA:
In adults with relapsed or refractory multiple myeloma after ≥4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
For autologous and IV use only; confirm patient identity prior to infusion. Do not use a leukodepleting filter. Give lymphodepleting chemotherapy (cyclophosphamide 300mg/m2 IV + fludarabine 30mg/m2 IV) for 3 days. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Abecma infusion; avoid prophylactic corticosteroids. Infuse Abecma 2 days after lymphodepleting chemotherapy. Dose range: 300–460×106 CAR-positive T cells. May need ≥1 infusion bag to achieve treatment dose. Management of severe adverse reactions: see full labeling.
<18yrs: not established.
Cytokine release syndrome (CRS). Neurologic toxicities. Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Prolonged cytopenia.
Risk of CRS; do not give to patients with active infection and/or inflammatory disorders. Have tocilizumab and emergency equipment readily available. Monitor at least daily for 7 days at the healthcare facility following infusion for signs/symptoms of CRS and neurologic toxicities. Continue to monitor for CRS for 4 weeks after infusion; at 1st sign, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated (see full labeling). Monitor for neurologic toxicities for 4 weeks after infusion and treat promptly (see full labeling). Evaluate for HLH/MAS if CRS or neurologic toxicities occur. Monitor for infection, febrile neutropenia, CMV reactivation; evaluate, manage and treat appropriately. Screen for CMV, HBV, HCV, and HIV prior to cell collection for manufacturing. Monitor blood counts (prior to and after initiation), immunoglobulin levels after treatment. Hepatic or renal impairment: not studied. Pregnancy: not recommended. Verify pregnancy status prior to initiation. Nursing mothers.
BCMA-directed genetically modified autologous T cell immunotherapy.
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Abecma treatment, and until immune recovery. May cause false (+) results in certain HIV nucleic acid tests.
Neutropenia, leukopenia, lymphopenia, thrombocytopenia, anemia, CRS, infections (pathogen unspecified), fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, decreased appetite; hypersensitivity reactions, neurologic toxicities, HLH/MAS, prolonged cytopenias, secondary malignancies (monitor).
Available only through a restricted REMS Program. For more information visit www.AbecmaREMS.com or call (888) 423-5436.
Generic Drug Availability:
Infusion bag (50mL, 250mL, 500mL)—1