YESCARTA Full Prescribing Information and Medication Guide

TECARTUS Full Prescribing Information and Medication Guide

YESCARTA logo and TECARTUS logo

Risk Evaluation and Mitigation Strategy (REMS)

What Is the YESCARTA and TECARTUS REMS?

A REMS is a program required by the United States (US) Food and Drug Administration (FDA). The FDA has determined that a REMS is necessary to ensure that the benefits of YESCARTA and TECARTUS outweigh the risks of cytokine release syndrome and neurologic toxicities. YESCARTA and TECARTUS are available only through the YESCARTA and TECARTUS REMS.

YESCARTA logo
TECARTUS logo
YESCARTA Prescribing Information and Medication Guidedownload

BOXED WARNING FOR YESCARTA

CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids, as needed.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS.

YESCARTA AND TECARTUS REMS REQUIREMENT

Hospitals and their associated clinics must be enrolled in the YESCARTA and TECARTUS REMS to be able to dispense YESCARTA and/or TECARTUS.

Hospital Enrollment Instructions

An authorized representative must enroll in the YESCARTA and TECARTUS REMS on behalf of the hospital and its associated clinics. To be enrolled in the YESCARTA and TECARTUS REMS, the representative must:

  1. Complete the YESCARTA and TECARTUS REMS Hospital Enrollment Form.
  2. Oversee implementation and compliance with the YESCARTA and TECARTUS REMS requirement:
    • Ensure that the hospital and its associated clinics have a minimum of 2 doses of tocilizumab available on-site for each patient and are ready for immediate administration (within 2 hours of infusion)

Indication

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
  • Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
    Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

TECARTUS Prescribing Information and Medication Guidedownload

BOXED WARNING FOR TECARTUS

CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with TECARTUS. Provide supportive care and/or corticosteroids, as needed.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.
  • TECARTUS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS.

YESCARTA AND TECARTUS REMS REQUIREMENT

Hospitals and their associated clinics must be enrolled in the YESCARTA and TECARTUS REMS to be able to dispense YESCARTA and/or TECARTUS.

Hospital Enrollment Instructions

An authorized representative must enroll in the YESCARTA and TECARTUS REMS on behalf of the hospital and its associated clinics. To be enrolled in the YESCARTA and TECARTUS REMS, the representative must:

  1. Complete the YESCARTA and TECARTUS REMS Hospital Enrollment Form.
  2. Oversee implementation and compliance with the YESCARTA and TECARTUS REMS requirement:
    • Ensure that the hospital and its associated clinics have a minimum of 2 doses of tocilizumab available on-site for each patient and are ready for immediate administration (within 2 hours of infusion)

Indication

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).