Abecma

Abecma (idecabtagene vicleucel) is a genetically modified autologous T cell immunotherapy directed against B-cell maturation antigen (BCMA), approved for intravenous infusion in adult patients with relapsed or refractory multiple myeloma after at least two prior therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. It carries risks of serious adverse reactions including cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenia, and secondary hematological malignancies.

Indicated for treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

idecabtagene vicleucel, dimethyl sulfoxide, water

For autologous use only. For intravenous infusion only. Dose based on CAR-positive T cells with a recommended range of 300 to 510 × 10^6 CAR-positive T cells administered as a single infusion dose (one or more infusion bags).

Pretreatment with lymphodepleting chemotherapy consisting of cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV daily for 3 days is required, with Abecma infusion two days after chemotherapy completion.

Premedicate with acetaminophen 650 mg orally and diphenhydramine 12.5 mg IV or 25 to 50 mg orally (or other H1-antihistamine) 30 to 60 minutes before infusion. Avoid prophylactic dexamethasone or systemic corticosteroids prior to infusion.

Confirm patient identity matches on all product labels before infusion.

Administer the thawed suspension within one hour of thaw initiation; the product is stable for up to two hours at room temperature post-thaw.

Infuse by gravity flow; do NOT use a leukodepleting filter. Prime tubing with normal saline before infusion and flush tubing after infusion with 30 to 60 mL normal saline at the same rate to ensure delivery of cells.

If multiple bags, thaw and infuse sequentially, completing one before thawing the next.

Delay infusion for up to 7 days if unresolved serious adverse events or active infection/inflammatory disorders are present.

Monitor patients daily for at least 7 days post-infusion for signs of cytokine release syndrome and neurologic toxicities. Patients should remain near a healthcare facility and avoid driving for at least 1 week post-treatment.

Boxed Warning: Fatal or life-threatening cytokine release syndrome (CRS) and neurologic toxicities have occurred. Do not administer to patients with active infections or inflammatory disorders. Treat CRS with tocilizumab and corticosteroids as indicated. Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged cytopenias with bleeding and infection, and secondary T cell malignancies have been reported after treatment. Monitor closely for these events and provide supportive care and corticosteroids as needed.