For autologous use only. For intravenous use only. 

2.1     Dosage in Pediatric and Young Adult Relapsed or Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) 

KYMRIAH is provided as a single-dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells.

Based on the patient weight reported at the time of leukapheresis:

- Patients 50 kg or less: administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight

- Patients above 50 kg: administer 0.1 to 2.5 x 108 CAR-positive viable T cells

2.2     Dosage in Adult Relapsed or Refractory (r/r) Diffuse Large B-cell lymphoma (DLBCL)

KYMRIAH is provided as a single-dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells.

 - For adult patients: administer 0.6 to 6.0 x 108 CAR-positive viable T cells  

2.3     Administration

Preparing Patient for KYMRIAH Administration with Lymphodepletion 

 - Confirm availability of KYMRIAH prior to starting the lymphodepleting regimen. 

Pediatric and Young Adult Relapsed or Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) 

Lymphodepleting chemotherapy: Fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2 intravenous daily for 2 days starting with the first dose of fludarabine). Infuse KYMRIAH 2 to 14 days after completion of the lymphodepleting chemotherapy. 

Adult Relapsed or Refractory (r/r) Diffuse Large B-cell lymphoma (DLBCL) 

• Lymphodepleting chemotherapy: Fludarabine (25 mg/m2 i.v. daily for 3 days) and cyclophosphamide (250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine). 

• Alternate lymphodepleting chemotherapy: bendamustine 90 mg/m2 i.v. daily for 2 days if a patient experienced a previous Grade 4 hemorrhagic cystitis with cyclophosphamide or demonstrates resistance to a previous cyclophosphamide containing regimen. 

• Infuse KYMRIAH 2 to 11 days after completion of the lymphodepleting chemotherapy. 

• Lymphodepleting chemotherapy may be omitted if a patient’s white blood cell (WBC) count is less than or equal to 1 x 109/L within 1 week prior to KYMRIAH infusion. 

Preparation of KYMRIAH for Infusion and Administration  

Delay the infusion of KYMRIAH if a patient has unresolved serious adverse reactions (including pulmonary reactions, cardiac reactions, or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden following lymphodepleting chemotherapy [see Warnings and Precautions (5.1)].