YESCARTA- axicabtagene ciloleucel suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AXICABTAGENE CILOLEUCEL (UNII: U2I8T43Y7R) (AXICABTAGENE CILOLEUCEL - UNII:U2I8T43Y7R)

Available from:

Kite Pharma, Inc.

INN (International Name):

AXICABTAGENE CILOLEUCEL

Composition:

AXICABTAGENE CILOLEUCEL 2000000 in 68 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

YESCARTA is indicated for the treatment of: - Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. - Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use : YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. YESCARTA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.2)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). None. Risk Summary There are no available data with YESCARTA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with YESCARTA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if YESCARTA has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, YESCARTA is not recommended for women who are pregnant, and pregnancy after YESCARTA infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. Risk Summary There is no information regarding the presence of YESCARTA in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YESCARTA and any potential adverse effects on the breastfed infant from YESCARTA or from the underlying maternal condition. Pregnancy Testing Pregnancy status of females with reproductive potential should be verified. Sexually active females of reproductive potential should have a pregnancy test prior to starting treatment with YESCARTA. Contraception See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with YESCARTA. Infertility There are no data on the effect of YESCARTA on fertility. The safety and efficacy of YESCARTA have not been established in pediatric patients. Of the 422 patients with NHL who received YESCARTA in clinical trials, 127 patients (30%) were 65 years of age and older. No clinically important differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients.

Product summary:

YESCARTA is supplied in an infusion bag (NDC 71287-119-01) containing approximately 68 mL of frozen suspension of genetically modified autologous T cells in 5% DMSO and 2.5% albumin (human). Each YESCARTA infusion bag is individually packed in a metal cassette (NDC 71287-119-02). YESCARTA is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen dry shipper.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Kite Pharma, Inc.
----------
MEDICATION GUIDE
YESCARTA (PRONOUNCED YES-KAR-TA)
(AXICABTAGENE CILOLEUCEL)
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: April 2024
Read this Medication Guide before you start your YESCARTA 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 YESCARTA?
YESCARTA may cause side effects that are life-threatening and can lead
to death. Call or see your
healthcare provider or get emergency help right away if you get any of
the following:
•
Fever (100.4°F/38°C or higher)
•
Difficulty breathing
•
Chills or shaking chills
•
Confusion
•
Dizziness or lightheadedness
•
Severe nausea, vomiting, or diarrhea
•
Fast or irregular heartbeat
•
Severe fatigue or weakness
It is important to tell your healthcare provider that you received
YESCARTA and to show them your
YESCARTA Patient Wallet Card. Your healthcare provider may give you
other medicines to treat your side
effects.
What is YESCARTA?
YESCARTA is a prescription medicine used to treat two types of
non-Hodgkin lymphoma:
•
large B-cell lymphoma when your first treatment did not work or your
cancer returned within a year
of first treatment, OR when at least two kinds of treatment have
failed to control your cancer.
•
follicular lymphoma when at least two kinds of treatment have failed
to control your cancer.
YESCARTA is different than other cancer medicines because it is made
from your own white blood cells,
which have been modified to recognize and attack your lymphoma cells.
Before getting YESCARTA, tell your healthcare provider about all your
medical problems, including if you
have or have had:
•
Neurologic problems (such as seizures, stroke, or memory loss)
•
Lung

Summary of Product characteristics

YESCARTA- AXICABTAGENE CILOLEUCEL SUSPENSION
KITE PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YESCARTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YESCARTA.
YESCARTA (AXICABTAGENE CILOLEUCEL) SUSPENSION FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2017
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES AND
SECONDARY
HEMATOLOGICAL MALIGNANCIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CYTOKINE RELEASE SYNDROME (CRS), INCLUDING FATAL OR LIFE-THREATENING
REACTIONS,
OCCURRED IN PATIENTS RECEIVING YESCARTA. DO NOT ADMINISTER YESCARTA TO
PATIENTS
WITH ACTIVE INFECTION OR INFLAMMATORY DISORDERS. TREAT SEVERE OR
LIFE-THREATENING CRS
WITH TOCILIZUMAB OR TOCILIZUMAB AND CORTICOSTEROIDS (2.2, 2.3, 5.1).
NEUROLOGIC TOXICITIES, INCLUDING FATAL OR LIFE-THREATENING REACTIONS,
OCCURRED IN
PATIENTS RECEIVING YESCARTA, INCLUDING CONCURRENTLY WITH CRS OR AFTER
CRS
RESOLUTION. MONITOR FOR NEUROLOGIC TOXICITIES AFTER TREATMENT WITH
YESCARTA. PROVIDE
SUPPORTIVE CARE AND/OR CORTICOSTEROIDS, AS NEEDED (2.2, 2.3, 5.2).
T CELL MALIGNANCIES HAVE OCCURRED FOLLOWING TREATMENT OF HEMATOLOGIC
MALIGNANCIES
WITH BCMA- AND CD19-DIRECTED GENETICALLY MODIFIED AUTOLOGOUS T CELL
IMMUNOTHERAPIES, INCLUDING YESCARTA (5.8).
YESCARTA IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM UNDER A RISK
EVALUATION
AND MITIGATION STRATEGY (REMS) CALLED THE YESCARTA AND TECARTUS REMS
PROGRAM
(5.3).
RECENT MAJOR CHANGES
Boxed Warning
04/2024
Warnings and Precautions, Secondary Malignancies (5.8)
04/2024
INDICATIONS AND USAGE
YESCARTA is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the
treatment of:
Adult patients with large B-cell lymphoma that is refractory to
first-line chemoimmunotherapy or that
relapses within 12 months of first-line chemoimmunotherapy. (1.1)
Adult patients with relapsed or refractory large B-cell lymphoma after
two or more lines of systemic
therapy, including diffuse large B-cell