Brexucabtagene Autoleucel
Generic Name: brexucabtagene autoleucel
Brand Names:
Tecartus
11 DESCRIPTION TECARTUS (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare TECARTUS, a patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains.
Overview
11 DESCRIPTION TECARTUS (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare TECARTUS, a patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains.
Uses
1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: 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. 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). 1.1 Mantle Cell Lymphoma Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Dosage
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Each single infusion bag of TECARTUS contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. 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 patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and diphenhydramine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicities [see Warnings and Precautions (5.2) ] Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Severe Infections [see Warnings and Precautions (5.5) ] Prolonged Cytopenias [see Warnings and Precautions (5.6) ] Hypogammaglobulinemia [see Warnings and Precautions (5.7) ] The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: fever, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection with pathogen unspecified, chil...
Warnings
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES 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 [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ] . 5 WARNINGS AND PRECAUTIONS Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome: Administer treatment per institutional standards. ( 5.3 ) Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.4 ) Severe Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.5 ) Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following TECARTUS infusion. Monitor complete blood counts. ( 5.6 ) Hypogammaglobulinemia: Monitor and provide replacement therapy. ( 5.7 ) Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy 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.
Storage
Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt. Store TECARTUS frozen in the vapor phase of liquid nitrogen (less than or equal to -150°C). TECARTUS may be stored for a single time at -80°C (+/- 10°C), for up to 90 days, and not exceeding the labeled expiration date.
Frequently Asked Questions
What is Brexucabtagene Autoleucel used for?▼
1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: 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. 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). 1.1 Mantle Cell Lymphoma Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
What are the side effects of Brexucabtagene Autoleucel?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicities [see Warnings and Precautions (5.2) ] Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Severe Infections [see Warnings and Precautions (5.5) ] Prolonged Cytopenias [see Warnings and Precautions (5.6) ] Hypogammaglobulinemia [see Warnings and Precautions (5.7) ] The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: fever, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection with pathogen unspecified, chil...
Can I take Brexucabtagene Autoleucel during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Brexucabtagene Autoleucel?▼
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES 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 [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ] . 5 WARNINGS AND PRECAUTIONS Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome: Administer treatment per institutional standards. ( 5.3 ) Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.4 ) Severe Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.5 ) Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following TECARTUS infusion. Monitor complete blood counts. ( 5.6 ) Hypogammaglobulinemia: Monitor and provide replacement therapy. ( 5.7 ) Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.