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

A single dose of KYMRIAH contains 0.2 to 5.0 x 106 CAR-positive viable T cells per kg of body weight for patients 50 kg or less, or 0.1 to 2.5 x 108 CAR-positive viable T cells for patients more than 50 kg, suspended in a patient-specific infusion bag for i.v. infusion. (3) 

Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma 

A single dose of KYMRIAH contains 0.6 to 6.0 x 108 CAR-positive viable T cells suspended in one or more patient-specific infusion bag(s) for i.v. infusion. (3) 

CONTRAINDICATIONS 

None. (4) 

WARNINGS AND PRECAUTIONS 

Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. (5.4)

Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately. (5.5) 

Prolonged Cytopenias: Patients may exhibit ≥ Grade 3 cytopenias for several weeks following KYMRIAH infusion. Prolonged neutropenia has been associated with increased risk of infection. (5.6)

Hypogammaglobulinemia: Monitor and provide replacement therapy until resolution. Assess immunoglobulin levels in newborns of mothers treated with KYMRIAH. (5.7) 

Secondary Malignancies: In the event that a secondary malignancy occurs after treatment with KYMRIAH, contact Novartis Pharmaceuticals Corporation at 1-844-4KYMRIAH. (5.8)

Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks after receiving KYMRIAH. (5.9)

ADVERSE REACTIONS 

Pediatric and Young Adult B-cell ALL (up to 25 years of age): The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, hypogammaglobulinemia, infections-pathogen unspecified, pyrexia, decreased appetite, headache, encephalopathy, hypotension, bleeding episodes, tachycardia, nausea, diarrhea, vomiting, viral infectious disorders, hypoxia, fatigue, acute kidney injury, edema, cough and delirium. (6) 

Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma: The most common adverse reactions (incidence greater than 20%) are CRS, infections-pathogen unspecified, pyrexia, diarrhea, nausea, fatigue, hypotension, edema and headache. (6) 

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2018

FULL PRESCRIBING INFORMATION: CONTENTS* 

WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES 

1     INDICATIONS AND USAGE 

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

1.2     Adult Relapsed or Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL) 

2     DOSAGE AND ADMINISTRATION 

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