INDICATION

ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy 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.

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ABECMA® Information and Resources for Nurses

You play a critical role in the ABECMA treatment process, helping RRMM patients navigate their journey with ABECMA. Get information and tools you need to help support your patients below.

From the treatment process to adverse event monitoring and management information, it’s here—so you can continue to guide your patients throughout their treatment journey.

RRMM=relapsed/refractory multiple myeloma.

A Demonstrated Safety Profile After a One-time Infusion With ABECMA1*

CRS and NT were generally predictable in KarMMa—most were low grade, with early onset and resolution1

  • The median time to onset for CRS was 1 day (range: 1 to 23 days), with a median duration of 7 days post infusion (range: 1 to 63 days)
  • The median time to onset for NT was 2 days (range: 1 to 42 days), with a median duration of 5 days (range: 1 to 61 days) in 33 of 36 patients who had a resolved NT

Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags.

For patients who experienced NT, including 3 patients with ongoing NT, the median duration of CAR T cell-associated NT was 6 days (range: 1 to 578 days).

Post-infusion monitoring and management1

During administration and at least daily for 7 days following ABECMA infusion, monitor your patients at the certified healthcare facility for adverse reactions.

Post ABECMA® infusion monitoring instructions Post ABECMA® infusion monitoring instructions
See the ABECMA
AE Management Tool

to learn more about presentation, monitoring, and management of adverse events.

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Monitoring and management of CRS and NT1

CRS

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Counsel patients and caregivers to seek immediate medical attention should signs or symptoms of CRS occur at any time

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Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion

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Monitor patients for signs and symptoms of CRS

  • At least daily for 7 days at the certified healthcare facility following ABECMA infusion
  • For at least 4 weeks after ABECMA infusion
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Treat at the first sign of CRS with supportive care, tocilizumab, and/or corticosteroids as needed based on the grading and management guidelines

  • If concurrent CRS is suspected during an NT event, manage CRS according to the recommendations in the full Prescribing Information
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Ensure that a minimum of 2 doses of tocilizumab per patient are available prior to infusion of ABECMA

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension

  • CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap
    • In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS
    • HLH/MAS is a potentially life-threatening condition, and patients should be closely monitored for evidence of HLH/MAS. Treatment of HLH/MAS should be administered per institutional standards

Patients who experience CRS should be closely monitored for cardiac and organ function until resolution of symptoms

  • For severe or life-threatening CRS, consider intensive care unit–level monitoring and supportive therapy

NT

Speech Bubbles Icon

Counsel patients and caregivers to seek immediate medical attention should signs or symptoms of NT occur at any time

Book with i Icon

Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion

Checklist with Hand Icon

Monitor patients for signs and symptoms of NT

  • At least daily for 7 days at the certified healthcare facility following ABECMA infusion
  • For at least 4 weeks after ABECMA infusion
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Exclude other causes of neurologic signs or symptoms

ABECMA® IV Infusion Icon

Treat promptly with supportive care and/or corticosteroids as needed based on the grading and management guidelines

HLH/MAS1

150-450 x 106 CAR-positive T cells (N=127)

  • HLH/MAS rates: 4% all grades (n=5)
  • One grade 5 HLH/MAS was observed. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome
  • Median time to onset: 7 days (range: 4-9 days)
  • HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional standards

Prolonged cytopenias1‡

150-450 x 106 CAR-positive T cells (N=127)

  • Prolonged neutropenia rates: 41% grade ≥3 (n=52)
    • Median time to recovery was 1.9 months in 83% (n=43/52) of patients who recovered from grade 3 or 4 neutropenia after
      month 1
  • Prolonged thrombocytopenia rates: 49% grade ≥3 (n=62)
    • Median time to recovery was 2.1 months in 65% (n=40/62) of patients who recovered from grade 3 or 4 thrombocytopenia
  • 2 of 3 patients who underwent hematopoietic reconstitution due to prolonged cytopenia died
  • Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines

Not resolved by month 1 following ABECMA infusion.

Long-term monitoring1

Warnings and precautions include:

  • CRS: 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
  • NT: NT, 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
  • HLH/MAS: HLH/MAS, including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or NT
  • Prolonged cytopenias: Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA. Patients may exhibit grade 3 or higher cytopenias for several weeks following pretreatment and ABECMA infusion. Monitor complete blood counts prior to and after ABECMA infusion
  • Hypersensitivity reactions: Monitor for hypersensitivity reactions during infusion
  • Infections: Monitor patients for signs and symptoms of infection; treat appropriately
  • Hypogammaglobulinemia: Monitor immunoglobulin levels after treatment. Manage using infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement
  • Use of live vaccines: Not recommended for at least 6 weeks prior to lymphodepleting chemotherapy, during treatment with ABECMA, and until immune recovery following treatment
  • Secondary malignancies: Monitor life-long. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin
  • Effects on ability to drive and use machines: Advise patients to refrain from driving or operating heavy or potentially dangerous machines for at least 8 weeks after ABECMA administration

AE=adverse event; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; HLH/MAS=hemophagocytic lymphohistiocytosis/macrophage activation syndrome; NT=neurologic toxicity; REMS=Risk Evaluation and Mitigation Strategy.

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