Tisagenlecleucel

Indications and Usage

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

• Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
• Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
  Limitation of Use: Kymriah is not indicated for 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 and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Side effects needing medical attention

Cytokine release syndrome, hypogammaglobulinemia, infections-pathogen unspecified, pyrexia (fever), decreased appetite, headache, encephalopathy, hypotension (low blood pressure), bleeding episodes, tachycardia (rapid heart rate), nausea, diarrhea, vomiting, viral infectious disorders, hypoxia (deprivation of oxygen to the brain), fatigue, acute kidney injury, and delirium.

WARNING:

Cytokine release syndrome and neurological toxicities

See full prescribing information for complete boxed warning.

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Kymriah. Do not administer Kymriah to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab.
• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with Kymriah, including concurrently with CRS. Monitor for neurological events after treatment with Kymriah. Provide supportive care as needed.
• Kymriah is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Kymriah REMS.