HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use  KYMRIAH  safely and effectively. See full prescribing information for  KYMRIAH . 

KYMRIAH ™ ( tisagenlecleucel ) suspension for  intravenous  infusion 

Initial U.S. Approval:  2017 

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 or tocilizumab and corticosteroids. (2.3, 2.4, 5.1) 

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. (5.2) 

KYMRIAH is available only through a restricted program under a Risk eva luation and Mitigation Strategy (REMS) called the KYMRIAH REMS. (5.3) 

RECENT MAJOR CHANGES 

Indications and Usage, Adult Relapsed or Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL) (1.2) 5/2018 

Dosage and Administration, Dosage in Adult Relapsed or Refractory (r/r) Diffuse Large B-cell lymphoma (DLBCL) (2.2) 5/2018 

Dosage and Administration, Administration (2.3) 5/2018 

Warnings and Precautions (5.1, 5.2, 5.5, 5.6, 5.7) 5/2018 

INDICATIONS AND USAGE 

KYMRIAH 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. (1.1) 

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 (1.2)

DOSAGE AND ADMINISTRATION 

For autologous use only. For intravenous use only. 

Administer a lymphodepleting regimen if needed before infusion of KYMRIAH  (2.3) 

Do NOT use a leukodepleting filter.

Verify the patient’s identity prior to infusion. (2)

Premedicate with acetaminophen and an H1-antihistamine. (2.3)

Confirm availability of tocilizumab prior to infusion. (2.3, 5.1)

Dosing of KYMRIAH is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.

Pediatric and Young Adult B-cell ALL (up to 25 years of age) 

• For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously. (2.1)

• For patients above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously. (2.1)

Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma 

Administer 0.6 to 6.0 x 108 CAR-positive viable T cells intravenously. (2.2)