Boxed Warning

CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI®. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.

  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.

  • BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.

About BREYANZI REMS

A REMS is a drug safety program to manage known or potential risks associated with a drug and is required by the United States (US) Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. BREYANZI is available only under a restricted program called BREYANZI REMS because of the serious risks of CRS and neurologic toxicities.

The goals of the BREYANZI REMS are to mitigate the risks of CRS and neurologic toxicities by:

  1. Ensuring that hospitals and their associated clinic(s) that dispense BREYANZI are specially certified and have on-site immediate access to tocilizumab.

  2. Ensuring that those who prescribe, dispense, or administer BREYANZI are aware of how to manage the risks of CRS and neurologic toxicities.

BREYANZI REMS Requirements

All hospitals and their associated clinic(s) must be certified and enrolled in the BREYANZI REMS to be able to infuse BREYANZI.

All relevant staff involved in the prescribing, dispensing, or administering of BREYANZI are trained on the BREYANZI REMS requirements, and must successfully complete the Knowledge Assessment and submit it to the REMS Program.

Hospital and Associated Clinic Enrollment Instructions

To become certified to infuse BREYANZI, hospitals and their associated clinic(s) must designate an authorized representative (AR) to complete REMS requirements and enroll in the BREYANZI REMS. The AR must:

  1. Complete the BREYANZI REMS Training Program (live in-person, via webcast, or online), which includes review of:

    • REMS Training Program

  2. Successfully complete the Knowledge Assessment and submit it to the REMS Program.

  3. Oversee implementation and compliance with the BREYANZI REMS requirements to:

    • Ensure all relevant staff involved in prescribing, dispensing, or administering of BREYANZI are trained on the REMS requirements using the Training Program, and successfully complete and submit the Knowledge Assessment, and records are maintained of staff training.

    • Put processes and procedures in place to ensure that staff involved in the prescribing, dispensing, or administering of BREYANZI are retrained on the BREYANZI REMS if BREYANZI has not been dispensed at least once annually from the date of certification in the BREYANZI REMS.

    • Dispense BREYANZI only after verifying a minimum of 2 doses of tocilizumab are available on-site for each patient and ready for immediate administration (within 2 hours of infusion).

    • Before discharge, provide patients/caregivers with the Patient Wallet Card and instruct patients to remain within 2 hours of the certified healthcare facility for at least 4 weeks following BREYANZI infusion.

    • Ensure that when the hospital and its associated clinic(s) designate an AR, the AR must complete the Training Program, successfully complete the Knowledge Assessment, and complete and submit a new Hospital Enrollment Form.

  4. Submit a completed Hospital Enrollment Form.

Report suspected adverse reactions to Bristol Myers Squibb at www.bms.com or 1-888-805-4555 or to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

Indication

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

  • refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or

  • refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or

  • relapsed or refractory disease after two or more lines of systemic therapy.

Limitation of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.