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

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

From clinical trial data to monitoring and management information, it’s all here—so you can continue to help your patients feel comfortable and secure throughout their treatment journey.

RRMM=relapsed/refractory multiple myeloma.

A Demonstrated Safety Profile After a One-Time Infusion With ABECMA®1*

A patient’s care team is the first line of defense when monitoring for AEs and treating them if they arise, and you play an important role in this post-infusion monitoring process. Below, you will find useful information on common AEs that may occur after ABECMA infusion.

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

CRS rates1,2†‡§

Median time to onset

1 day
Range: 1-23 days

Median duration

7 days
Range: 1-63 days
9% Grade ≥3 (n=12) /
85% All grades (n=108) /
46% Grade 1 (n=58) /
30% Grade 2 (n=38) /
Grade 5 CRS was reported in one (0.8%) patient.
CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA.

NT rates1,2†‡

Median time to onset

2 days
Range: 1-42 days

Median duration

5|| days
Range: 1-61 days

In 33 of 36 patients
who had resolved NT

4% Grade 3 (n=5) /
28% All grades (n=36) /
17% Grade 1 (n=21) /
8% Grade 2 (n=10)
There were no grade 4 or 5 NT events in KarMMa.
Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS (n=34), with onset during CRS (n=29), before CRS (n=3), after CRS resolution (n=2), or in the absence of CRS.

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.

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

Data at primary analysis. Safety profile remained consistent with longer follow-up and no new safety signals were observed.

Lee criterial for grading CRS (Lee et al, 2014).

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).

See the ABECMA Nurse-to-Patient Dialogue Tool

for tips on how to discuss adverse events with your patients.

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Monitoring and management of CRS and NT1

CRS

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

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 CRS

  • At least daily for 7 days at the certified healthcare facility following ABECMA infusion
  • For at least 4 weeks after ABECMA infusion
ABECMA® IV Infusion Icon

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
Checkmark Icon

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

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

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

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

Information Icon

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

See the ABECMA
AE Management Tool

to learn more about presentation, monitoring, and management of AEs.

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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

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)

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
See the ABECMA
Clinician Guide for Nurses

to learn more about managing
adverse reactions.

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ABECMA REMS1

Due to the risk of CRS and NT, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

The required components of the ABECMA REMS are:

  • Healthcare facilities that dispense and administer ABECMA must be enrolled and comply with the REMS requirements
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab
  • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after ABECMA infusion, if needed for treatment of CRS
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer ABECMA are trained on the management of CRS and NT
  • Further information is available at www.AbecmaREMS.com, or contact Bristol Myers Squibb at 1-888-423-54361-888-423-5436

AEs=adverse events; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; HLH/MAS=hemophagocytic lymphohistiocytosis/macrophage activation syndrome; NT=neurologic toxicity.

Learn more about ABECMA
efficacy

See more ABECMA safety
information