TECARTUS- brexucabtagene autoleucel suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BREXUCABTAGENE AUTOLEUCEL (UNII: 4MD2J2T8SJ) (BREXUCABTAGENE AUTOLEUCEL - UNII:4MD2J2T8SJ)

Available from:

Kite Pharma, Inc.

Administration route:

INTRAVENOUS

Therapeutic indications:

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). None. Risk Summary There are no available data with TECARTUS use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with TECARTUS to assess whether TECARTUS can cause fetal harm when administered to a pregnant woman. It is not known if TECARTUS has the potential to be transferred to the fetus. Based on the mechanism of action of TECARTUS, if the transduced cells cross the placenta, they may cause fetal toxicity, including B cell lymphocytopenia. Therefore, TECARTUS is not recommended for women who are pregnant. Pregnancy after TECARTUS 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 TECARTUS 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 TECARTUS and any potential adverse effects on the breastfed infant from TECARTUS 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 negative pregnancy test prior to starting treatment with TECARTUS. 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 TECARTUS. Infertility There are no data on the effect of TECARTUS on fertility. The safety and efficacy of TECARTUS have not been established in pediatric patients. Of the 82 patients treated with TECARTUS for MCL, 42 (51%) were 65 years of age and over. Of the 78 patients treated with TECARTUS for ALL, 12 (15%) were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Product summary:

TECARTUS is supplied in an infusion bag containing approximately 68 mL of frozen suspension of genetically modified autologous T cells in 5% DMSO and human serum albumin. Each TECARTUS infusion bag is individually packed in a metal cassette. TECARTUS 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.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised: October
2021
MEDICATION GUIDE
TECARTUS (pronounced tek-ahr-tuhs)
(brexucabtagene autoleucel)
Read this Medication Guide before you start your TECARTUS 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 TECARTUS?
TECARTUS 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
TECARTUS and to show them your
TECARTUS Patient Wallet Card. Your healthcare provider may give you
other medicines to treat your
side effects.
What is TECARTUS?
TECARTUS is a treatment for adults with mantle cell lymphoma or acute
lymphoblastic leukemia. It is
used following disease progression while on or after other treatment.
TECARTUS 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 TECARTUS, 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 or breathing problems
•
Heart problems
•
Liver problems
•
Kidney problems
•
A recent or active infection
Tell your healthcare provider about all the medications you take,
including prescription and

Summary of Product characteristics

TECARTUS- BREXUCABTAGENE AUTOLEUCEL SUSPENSION
KITE PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TECARTUS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TECARTUS.
TECARTUS (BREXUCABTAGENE AUTOLEUCEL) SUSPENSION FOR INTRAVENOUS
INFUSION
INITIAL U.S. APPROVAL: 2020
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CYTOKINE RELEASE SYNDROME (CRS), INCLUDING LIFE-THREATENING REACTIONS,
OCCURRED IN
PATIENTS RECEIVING TECARTUS. DO NOT ADMINISTER TECARTUS 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 LIFE-THREATENING REACTIONS, OCCURRED
IN PATIENTS
RECEIVING TECARTUS, INCLUDING CONCURRENTLY WITH CRS OR AFTER CRS
RESOLUTION. MONITOR
FOR NEUROLOGIC TOXICITIES AFTER TREATMENT WITH TECARTUS. PROVIDE
SUPPORTIVE CARE
AND/OR CORTICOSTEROIDS, AS NEEDED (2.2, 2.3, 5.2).
TECARTUS IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM UNDER A RISK
EVALUATION
AND MITIGATION STRATEGY (REMS) CALLED THE YESCARTA AND TECARTUS REMS
PROGRAM
(5.3).
INDICATIONS AND USAGE
TECARTUS is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the
treatment of: (1)
Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on
overall response rate and durability of
response. Continued approval for this indication may be contingent
upon verification and description of
clinical benefit in a confirmatory trial.
Adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (ALL).
DOSAGE AND ADMINISTRATION
FOR AUTOLOGOUS USE ONLY. FOR INTRAVENOUS USE ONLY.
Do NOT use a leukodepleting filter.
Administer a lymphodepleting regimen of cyclophosphamide and
fludarabine before infusion of
TECARTUS. (2.2)
Verify the patien