KYMRIAH- tisagenlecleucel injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TISAGENLECLEUCEL (UNII: Q6C9WHR03O) (TISAGENLECLEUCEL - UNII:Q6C9WHR03O)

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

TISAGENLECLEUCEL

Composition:

TISAGENLECLEUCEL 2000000

Administration route:

INTRAVENOUS

Therapeutic indications:

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. 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. Adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14.3)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). None. R

Product summary:

KYMRIAH is supplied as a frozen suspension of genetically modified autologous T cells in an infusion bag(s) labeled for the specific recipient. KYMRIAH is shipped directly to the cell lab associated with the infusion center in a liquid nitrogen Dewar. Product and patient-specific labels are located inside the Dewar. Ped ALL: NDC 0078-0846-19 DLBCL and FL: NDC 0078-0958-19

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Novartis Pharmaceuticals Corporation
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This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: May 2022
MEDICATION GUIDE
KYMRIAH® (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 healthcare providers that you have
received KYMRIAH. Your healthcare
providers may give you other medicines to treat your side effects.
What is KYMRIAH?
KYMRIAH is made from your own white blood cells and is a prescription
cancer treatment used in patients
up to 25 years old who have acute lymphoblastic leukemia (ALL) that is
either relapsing (went into
remission, then came back) or refractory (did not go into remission
after receiving other leukemia
treatments). It is also used in patients with large B-cell lymphoma or
follicular lymphoma, two types of non-
Hodgkin lymphoma, that have relapsed or are refractory after having at
least two other kinds of treatment.
How will I get KYMRIAH?
Since KYMRIAH is made from your own white blood cells, your healthcare
provider has to take some of
your blood. This is called “leukapheresis.” It takes 3 to 6 hours
and may need to be repeated. A tube
(intravenous catheter) will be placed in your vein to collect your

Summary of Product characteristics

KYMRIAH- TISAGENLECLEUCEL INJECTION, SUSPENSION
NOVARTIS PHARMACEUTICALS CORPORATION
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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
EVALUATION AND
MITIGATION STRATEGY (REMS) CALLED THE KYMRIAH REMS. (5.3)
RECENT MAJOR CHANGES
Indications and Usage, Adult Relapsed or Refractory (r/r) Follicular
Lymphoma (FL)
(1.3)
5/2022
Dosage and Administration Adult Relapsed or Refractory (r/r)
Follicular Lymphoma
(FL) (2.2, 2.3)
5/2022
Management of Severe Adverse Reactions (2.4)
5/2022
Warnings and Precautions (5.1, 5.2, 5.4, 5.6, 5.7, 5.8)
5/2022
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