Brexucabtagene autoleucel

What is Brexucabtagene autoleucel?

• Brexucabtagene autoleucel (Tecartus) is a CD19-directed genetically modified autologous T cell immunotherapy used for the treatment of mantle cell lymphoma (MCL) and acute lymphoblastic leukemia (ALL).

What are the uses of this medicine?

• Brexucabtagene autoleucel (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.

How does this medicine work?

• Tecartus, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells.
• Upon intravenous infusion and re-introduction of abrexucabtagene autoleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells.
• CD19 antigen is a B-cell specific cell surface antigen that is expressed in all B-cell lineage malignancies.
• CD3 zeta is one of several membrane-bound polypeptides found in the TCR/CD3 complex; it regulates both the assembly and cell surface expression of TCR complexes.
• CD28 is essential for CD4+ T-cell proliferation, interleukin-2 production, and T-helper type-2 (Th2) development.
• KTE-X19 has the same construct as axicabtagene ciloleucel, but differs in the manufacturing process in that KTE-X19 includes specific T-cell selection and lymphocyte enrichment necessary for activity against certain B-cell malignancies.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Tecartus.

Is this medicine FDA approved?

• Brexucabtagene autoleucel was approved for medical use in the United States in July 2020, and in the European Union in December 2020.

How should this medicine be used?

• Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of Tecartus.
• Verify the patient's identity prior to infusion.
• Premedicate with acetaminophen and diphenhydramine.
• Confirm availability of tocilizumab prior to infusion.

Recommended dosage:

• Dosing of Tecartus is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.

Recommended Dosage for Mantle cell lymphoma (MCL):

• The target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Recommended Dosage for Acute lymphoblastic leukemia (ALL):

• The target dose is 1 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 108 CAR-positive viable T cells.

Administration:

• Since Tecartus is made from your own white blood cells, your blood will be collected by a process called "leukapheresis" (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
• Your blood cells will be sent to a manufacturing center to make your Tecartus.
• Before you get Tecartus, you will get three days of chemotherapy to prepare your body.
• When your Tecartus is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
• You will be monitored where you received your treatment daily for at least seven days for patients with MCL and at least 14 days for patients with ALL after the infusion.
• You should plan to stay close to the location where you received your treatment for at least four weeks after getting Tecartus. Your healthcare provider will help you with any side effects that may occur.
• You may be hospitalized for side effects. Your healthcare provider will discharge you if your side effects are under control and it is safe for you to leave the hospital.
• Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As suspension for intravenous infusion

This medicine is available in fallowing brand namesː

• Tecartus

What side effects can this medication cause?

The most common side effects of this medicine include:

• Fever (100.4°F/38°C or higher)
• Low white blood cells (can occur with a fever)
• Low red blood cells
• Low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
• Fast heartbeat
• Confusion
• Difficulty speaking or slurred speech
• Nausea
• Diarrhea

Tecartus may cause side effects that are life-threatening and can lead to death

• 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

What special precautions should I follow?

• CRS, including fatal or life-threatening reactions, occurred following treatment with Tecartus. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.
• Neurologic events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Monitor patients for signs or symptoms of neurologic toxicities for four weeks after infusion and treat promptly.
• Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and Tecartus REMS Program.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including life-threatening reactions, occurred following treatment with Tecartus. Administer treatment per institutional standards.
• Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus. Monitor for hypersensitivity reactions during infusion.
• Severe or life-threatening infections occurred in patients after Tecartus infusion. Monitor patients for signs and symptoms of infection; treat appropriately.
• Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. Monitor complete blood counts.
• B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Monitor and provide replacement therapy.
• Patients treated with Tecartus may develop secondary malignancies. In the event that a secondary malignancy occurs after treatment with Tecartus, contact Kite at 1-844-454-KITE (5483).
• Due to the potential for neurologic events, including altered mental status or seizures, patients receiving Tecartus are at risk for altered or decreased consciousness or coordination in the eight weeks following Tecartus infusion.
• Do not drive, operate heavy machinery, or do other dangerous things for eight weeks after you get Tecartus because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
• Do not donate blood, organs, tissues, or cells for transplantation.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data with Tecartus use in pregnant women.
• Therefore, Tecartus is not recommended for women who are pregnant.

Can this medicine be used in children?

• The safety and efficacy of Tecartus have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredients: brexucabtagene autoleucel.
• Inactive ingredients: albumin (human); DMSO.

Who manufactures and distributes this medicine?

Manufactured by, Packed by, Distributed by:

• Kite Pharma, Inc.
• Santa Monica, CA

• Tecartus is a trademark of Kite Pharma, Inc.

What should I know about storage and disposal of this medication?

• Store Tecartus frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C).
• Thaw before using.

• Dailymed label info on Brexucabtagene autoleucel
• FDA Brexucabtagene autoleucel

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