Neurological Toxicities -- Report altered or decreased consciousness, delirium, confusion, agitation, seizures, difficulty speaking and understanding, or loss of balance to their healthcare professional [see Warnings and Precautions (5.2), Adverse Reactions (6.1)]. 

Serious Infections -- KYMRIAH may cause serious infections. Advise patients that they will be screened for HBV, HCV, and HIV before collection of cells [see Warnings and Precautions (5.5), Adverse Reactions (6.1)]. 

Hypogammaglobulinemia -- Patients may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with KYMRIAH. Patients should tell their physician about their treatment with KYMRIAH before receiving a live virus vaccine [see Warnings and Precautions (5.7), Adverse Reactions (6.1)]. 

Driving and Engaging in Hazardous Occupations -- Patients should refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks after treatment [see Warnings and Precautions (5.9)].

Prolonged Cytopenia -- Patient may exhibit signs or symptoms associated with bone marrow suppression (i.e., neutropenia, thrombocytopenia and anemia) for several weeks following lymphodepleting chemotherapy and KYMRIAH.

Patients should be instructed to contact Novartis Pharmaceuticals Corporation at 1-844-4KYMRIAH if they get secondary malignancies [see Warnings and Precautions (5.8)]. 

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

T2018-67

MEDICATION GUIDE 

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: May 2018 

MEDICATION GUIDE 

KYMRIAHTM (pronounced KIM-RYE-AH) 

(tisagenlecleucel) 

Read this Medication Guide before you start your KYMRIAH treatment. The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment. 

What is the most important information I should know about KYMRIAH? 

KYMRIAH may cause side effects that are severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: 

difficulty breathing

fever (100.4°F/38°C or higher)

chills/shaking chills

confusion

severe nausea, vomiting, diarrhea

severe muscle or joint pain

very low blood pressure

dizziness/lightheadedness

It is important that you tell your health care providers that you have received KYMRIAH. Your healthcare providers may give you other medicines to treat your side effects.

What is KYMRIAH?