BREYANZI- lisocabtagene maraleucel kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LISOCABTAGENE MARALEUCEL (UNII: 7K2YOJ14X0) (LISOCABTAGENE MARALEUCEL - UNII:7K2YOJ14X0)

Available from:

Juno Therapeutics, Inc.

Therapeutic indications:

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have: Limitations of Use : BREYANZI is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma [see Clinical Studies (14)]. None. Risk Summary There are no available data with BREYANZI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with BREYANZI to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if BREYANZI 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 and hypogammaglobulinemia. Therefore, BREYANZI is not recommended for women who are pregnant, and pregnancy after BREYANZI 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% to 4% and 15% to 20%, respectively. Risk Summary There is no information regarding the presence of BREYANZI 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 BREYANZI and any potential adverse effects on the breastfed infant from BREYANZI 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 BREYANZI. Contraception See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with BREYANZI. Infertility There are no data on the effects of BREYANZI on fertility. The safety and efficacy of BREYANZI have not been established in pediatric patients. In clinical trials of BREYANZI, 111 (41%) of 268 patients with two or more prior lines of therapy for LBCL, and 89 (59%) of 150 patients with one prior line of therapy for LBCL, were 65 years of age or older; 27 (10%) and 28 (19%) were 75 years of age or older, respectively. No clinically important differences in safety or effectiveness of BREYANZI were observed between patients aged ≥ 65 and younger patients.

Product summary:

BREYANZI consists of genetically modified autologous T cells, supplied in vials as separate frozen suspensions of each CD8 component (NDC 73153-901-08) and CD4 component (NDC 73153-902-04). Each CD8 or CD4 component is packed in a carton containing up to 4 vials, depending upon the concentration of the cryopreserved drug product CAR-positive viable T cells. The cartons for each CD8 component and CD4 component are in an outer carton (NDC 73153-900-01). BREYANZI is shipped directly to the cell lab or clinical pharmacy associated with the infusion center in the vapor phase of a liquid nitrogen shipper. A Release for Infusion (RFI) Certificate for each component and patient-specific syringe labels are affixed inside the shipper.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Juno Therapeutics, Inc.
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MEDICATION GUIDE
BREYANZI® (PRONOUNCED BRAYE AN' ZEE)
(LISOCABTAGENE MARALEUCEL)
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised: June
2023
Read this Medication Guide before you start your BREYANZI 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 BREYANZI?
BREYANZI may cause side effects that are life-threatening and can lead
to death. 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
•
fast or irregular heartbeat
•
dizziness/lightheadedness
•
severe fatigue or weakness
It is important that you tell your healthcare providers that you have
received BREYANZI and to show
them your BREYANZI Patient Wallet Card. Your healthcare provider may
give you other medicines to
treat your side effects.
What is BREYANZI?
BREYANZI is a prescription medicine used to treat large B cell
lymphoma, a type of non-Hodgkin
lymphoma, when:
•
your first treatment has not worked or your cancer returned within a
year of your first treatment OR
•
your first treatment has not worked or your cancer returned after the
first treatment, and you are not
eligible for hematopoietic stem cell transplantation because of
medical conditions or age OR
•
two or more kinds of treatment have not worked or stopped working.
BREYANZI is different than other cancer medicines because it is made
from your own white blood cells,
MEDICATION GUIDE
BREYANZI® (PRONOUNCED BRAYE AN' ZEE)
(LISOCABTAGENE MARALEUCEL)
which have been genetically modified to recognize and attack your
lymphoma

Summary of Product characteristics

BREYANZI- LISOCABTAGENE MARALEUCEL
JUNO THERAPEUTICS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BREYANZI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BREYANZI.
BREYANZI (LISOCABTAGENE MARALEUCEL) SUSPENSION FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2021
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
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INDICATIONS AND USAGE
BREYANZI is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the
treatment of adult patients with large B-cell lymphoma (LBCL),
including diffuse large B-cell lymphoma
(DLBCL) not otherwise specified (including DLBCL arising from indolent
lymphoma), high-grade B-cell
lymphoma, primary mediastinal large B-cell lymphoma, and follicular
lymphoma grade 3B, who have:
•
•
•
Limitations of Use: BREYANZI is not indicated for the treatment of
patients with primary central nervous
system lymphoma (1, 14).
DOSAGE AND ADMINISTRATION
FOR AUTOLOGOUS USE ONLY. FOR INTRAVENOUS USE ONLY.
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•
•
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
•
®
CYTOKINE RELEASE SYNDROME (CRS), INCLUDING FATAL OR LIFE-THREATENING
REACTIONS,
OCCURRED IN PATIENTS RECEIVING BREYANZI. DO NOT ADMINISTER BREYANZI TO
PATIENTS
WITH ACTIVE INFECTION OR INFLAMMATORY DISORDERS. TREAT SEVERE OR
LIFE-THREATENING
CRS WITH TOCILIZUMAB WITH OR WITHOUT CORTICOSTEROIDS (2.2, 2.3, 5.1).
NEUROLOGIC TOXICITIES, INCLUDING FATAL OR LIFE-THREATENING REACTIONS,
OCCURRED IN
PATIENTS RECEIVING BREYANZI, INCLUDING CONCURRENTLY WITH CRS, AFTER
CRS RESOLUTION,
OR IN THE ABSENCE OF CRS. MONITOR FOR NEUROLOGIC EVENTS AFTER
TREATMENT WITH
BREYANZI. PROVIDE SUPPORTIVE CARE AND/OR CORTICOSTEROIDS AS NEEDED
(2.2, 2.3,
5.2).
BREYANZI IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM UNDER A RISK
EVALUATION
AND MITIGATION STRATEGY (REMS) CALLED THE BREYANZI REMS (5.3).
refractory disease to first-line chemoimmunotherapy or relapse wit