Abecma

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Abecma Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Idecabtagene vicleucel (contains 300–460×10^6 CAR-positive T cells); per 1 or more infusion bags; cell susp for IV infusion; contains dimethyl sulfoxide (DMSO).

    Pharmacological Class

    BCMA-directed genetically modified autologous T cell immunotherapy.

    How Supplied

    Infusion bag (50mL, 250mL, 500mL)—1

    Manufacturer

    Bristol Myers Squibb

    Generic Availability

    NO

    Mechanism of Action

    Idecabtagene vicleucel is a chimeric antigen receptor (CAR)-positive T cell therapy that targets B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

    Abecma Indications

    Indications

    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.

    Abecma Dosage and Administration

    Adult

    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.

    Children

    <18yrs: not established.

    Abecma Contraindications

    Not Applicable

    Abecma Boxed Warnings

    Boxed Warning

    Cytokine release syndrome (CRS). Neurologic toxicities. Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Prolonged cytopenia.

    Abecma Warnings/Precautions

    Warnings/Precautions

    Risk of CRS; avoid in those 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.

    REMS

    YES

    Abecma Pharmacokinetics

    See Literature

    Abecma Interactions

    Interactions

    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.

    Abecma Adverse Reactions

    Adverse Reactions

    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, secondary malignancies (monitor).

    Abecma Clinical Trials

    See Literature

    Abecma Note

    Notes

    Available only through a restricted REMS Program. For more information visit www.AbecmaREMS.com or call (888) 423-5436.

    Abecma Patient Counseling

    See Literature

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