2.3     Administration 

2.4     Management of Severe Adverse Reactions 

3     DOSAGE FORMS AND STRENGTHS 

4     CONTRAINDICATIONS 

5     WARNINGS AND PRECAUTIONS 

5.1     Cytokine Release Syndrome (CRS) 

5.2     Neurological Toxicities 

5.3     KYMRIAH REMS to Mitigate Cytokine Release Syndrome and Neurological Toxicities 

5.4     Hypersensitivity Reactions 

5.5     Serious Infections 

5.6     Prolonged Cytopenias 

5.7     Hypogammaglobulinemia 

5.8     Secondary Malignancies 

5.9     Effects on Ability to Drive and Use Machines 

6     ADVERSE REACTIONS 

6.1     Clinical Trials Experience  

6.2     Immunogenicity 

7     DRUG INTERACTIONS 

8     USE IN SPECIFIC POPULATIONS 

8.1     Pregnancy 

8.2     Lactation 

8.3     Females and Males of Reproductive Potential 

8.4     Pediatric Use 

8.5     Geriatric Use 

11     DESCRIPTION 

12     CLINICAL PHARMACOLOGY 

12.1     Mechanism of Action 

12.3     Pharmacokinetics/Cellular Kinetics 

13     NONCLINICAL TOXICOLOGY 

13.1     Carcinogenesis, Mutagenesis, Impairment of Fertility 

14     CLINICAL STUDIES 

14.1     Relapsed or Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL)  

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

15     REFERENCES 

16     HOW SUPPLIED/STORAGE AND HANDLING 

17     PATIENT COUNSELING INFORMATION  

* Sections or subsections omitted from the full prescribing information are not listed.  

1     INDICATIONS AND USAGE 

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

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

Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

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

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.