TECARTUS brexucabtagene autoleucel 1000000 1/68mL Suspension, 68 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antineoplastic cell and gene therapy class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Brexucabtagene autoleucel is used to treat mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system) in adults that has returned or is unresponsive to other treatment(s). Brexucabtagene autoleucel is also used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in adults that has returned or is unresponsive to other treatment(s). Brexucabtagene autoleucel injection is in a class of medications called autologous cellular immunotherapy, a...
Read the full MedlinePlus article ↗- Tecartus is made from your own immune cells, not a chemical drug. Your T cells are collected from your blood, sent to a lab where they're genetically reprogrammed to find and kill...
- What exactly is Tecartus and how is it different from regular chemotherapy?
- Most people experience fever, chills, low blood pressure, rapid heartbeat, fatigue, and nausea in the days after infusion — these are common and your care team will be watching for...
- What side effects should I be ready for, and which ones are serious enough to call about right away?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
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UNII YOW8V9698H
Dimethyl sulfoxide is a clear liquid solvent derived from wood pulp. In medicines, it helps dissolve or carry active ingredients and improve how the body absorbs the drug.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tecartus 1000000 1/68mLthis 71287-0220-02 | Kite | 68 ml | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jul 24, 2032 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71287-0220-02 You're viewing this | 1 BAG in 1 PACKAGE (71287-220-02) / 68 mL in 1 BAG (71287-220-01) | 2021-10-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
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) ] .
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 [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.2) ] .
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies [see Warnings and Precautions (5.8) ] . WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES 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 ). T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies ( 5.8 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
1.1Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
1.2Acute Lymphoblastic Leukemia TECARTUS is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
⏱️ Dosage and Administration ▾
2 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 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. ( 2.1 ) MCL: dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells.
( 2.1 ) ALL: dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. ( 2.1 )
2.1Dose For autologous use only. For intravenous use only. Recommended Dosage for MCL The target dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. Recommended Dosage for ALL The target dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells.
2.2Administration TECARTUS is for autologous use only. The patient's identity must match the patient identifiers on the TECARTUS cassette and infusion bag. Do not infuse TECARTUS if the information on the patient-specific label does not match the intended patient.
Preparing Patient for TECARTUS Infusion Confirm availability of TECARTUS prior to starting the lymphodepleting chemotherapy regimen. Pre-treatment MCL: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on each of the fifth, fourth, and third day before infusion of TECARTUS. ALL: Administer a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m 2 intravenously over 30 minutes on the fourth, third, and second day and administer cyclophosphamide 900 mg/m 2 over 60 minutes on the second day before infusion of TECARTUS.
Premedication Premedicate with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to TECARTUS infusion. Avoid prophylactic use of systemic corticosteroids as it may interfere with the activity of TECARTUS. Preparation of TECARTUS for infusion Coordinate the timing of TECARTUS thaw and infusion.
Confirm the infusion time in advance, and adjust the start time of TECARTUS thaw such that TECARTUS will be available for infusion when the patient is ready. Confirm patient identity: Prior to TECARTUS preparation, match the patient's identity with the patient identifiers on the TECARTUS cassette. Do not remove the TECARTUS infusion bag from the cassette if the patient information on the cassette label does not match the intended patient.
Once patient identity is confirmed, remove the TECARTUS infusion bag from the cassette and check that the patient information on the cassette label matches the patient information on the bag label. Inspect the infusion bag for any breaches of container integrity such as breaks or cracks before thawing. If the bag is compromised, follow the local guidelines (or call Kite at 1-844-454-KITE).
Place the infusion bag inside a second sterile bag per local guidelines. Thaw the infusion bag at approximately 37°C using either a water bath or dry-thaw method until there is no visible ice in the infusion bag. Gently mix the contents of the bag to disperse clumps of cellular material.
If visible cell clumps remain, continue to gently mix the contents of the bag. Small clumps of cellular material should disperse with gentle manual mixing. Do not wash, spin down, and/or re-suspend TECARTUS in new media prior to infusion.
Once thawed, TECARTUS should be administered within 30 minutes but may be stored at room temperature (20°C to 25°C) for up to 3 hours. Administration For autologous use only. Confirm that tocilizumab and emergency equipment are available prior to…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS TECARTUS is available as a cell suspension for infusion. MCL: A single dose of TECARTUS contains 2 × 10 6 CAR-positive viable T cells per kg of body weight [maximum of 2 × 10 8 CAR-positive viable T cells (for patients 100 kg and above)] in approximately 68 mL suspension in an infusion bag [see How Supplied/Storage and Handling (16) ] . ALL: A single dose of TECARTUS contains 1 × 10 6 CAR-positive viable T cells per kg of body weight [maximum of 1 × 10 8 CAR-positive viable T cells (for patients 100 kg and above)] in approximately 68 mL suspension in an infusion bag [see How Supplied/Storage and Handling (16) ] .
TECARTUS is available as a cell suspension for infusion. MCL: Comprises a suspension of 2 × 10 6 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells in approximately 68 mL. ( 3 ) ALL: Comprises a suspension of 1 × 10 6 CAR-positive viable T cells per kg of body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells in approximately 68 mL.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
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. In the event that a secondary malignancy occurs after treatment with TECARTUS, contact Kite at 1-844-454-KITE (5483). ( 5.8 )
5.1Cytokine Release Syndrome Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with TECARTUS. CRS occurred in 93% (157/168) of patients with MCL, including ≥ Grade 3 (Lee 2014 grading system 1 ) CRS in 12% of patients in Study 1. Among the patients with MCL who died after receiving TECARTUS, 1 patient had a fatal CRS event.
The median time to onset of CRS was 4 days (range: 1 to 13 days). The median duration of CRS was 7 days (range: 1 to 50 days). CRS occurred in 92% (72/78) of patients with ALL, including ≥ Grade 3 (Lee grading system 1 ) CRS in 26% of patients.
Three patients with ALL had ongoing CRS events at the time of death. The median time to onset of CRS was 5 days (range: 1 to 12 days) and the median duration of CRS was 8 days (range: 2 to 63 days) for patients with ALL. Confirm that a minimum of 2 doses of tocilizumab are available for each patient prior to infusion of TECARTUS.
Monitor patients daily for at least 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated [see Dosage and Administration (2.3) ] .
5.2Neurologic Toxicities Neurologic toxicities (including ICANS), which may be severe, life-threatening or fatal, occurred following treatment with TECARTUS. Neurologic events occurred in 80% (135/168) of patients with MCL, including ≥ Grade 3 in 33% of patients in Study 1. The median time to onset for neurologic events was 6 days (range: 1 to 32 days).
The median duration of neurologic events was 19 days (range: 1 to 828 days). Neurologic events occurred in 87% (68/78) of patients with ALL, including ≥ Grade 3 in 35% of patients. The median time to onset for neurologic events was 7 days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL.
For patients with MCL 105 (63%) patients experienced CRS before the onset of neurological events. Six (4%) patients did not experience CRS with neurologic events and 25 patients (15%) developed neurological events after the resolution of CRS. Neurologic events resolved for 167 out of 203 (82%) patients treated with TECARTUS.
Fourteen patients (8 patients with MCL and 6 patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS.
The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS. Monitor patients daily for at least 7 days following infusion for signs and symptoms of neurologic toxicity/ICANS. Monitor patients for signs or symptoms of neurologic toxicities for 2 weeks after infusion and treat promptly [see Dosage and Administration…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction. ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Kite at 1-844-454-KITE (5483) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Study 1 (Relapsed/Refractory Mantle Cell Lymphoma) Cohort 1 and 2 The safety of TECARTUS in patients with relapsed/refractory Mantle cell lymphoma (MCL) was evaluated in a single-arm study (Study 1; Cohorts 1 and 2) in which a total of 82 patients received a single dose of TECARTUS (2 × 10 6 or 0.5 × 10 6 anti-CD19 CAR T cells/kg) [see Clinical Studies (14.1) ] .
The most common serious adverse reactions (> 2%) were encephalopathy, fever, infection with pathogen unspecified, CRS, hypoxia, aphasia, renal insufficiency, pleural effusion, respiratory failure, bacterial infections, dyspnea, fatigue, arrhythmia, tachycardia, and viral infections. Table 3 summarizes the adverse reactions that occurred in at least 10% of patients in Study 1 Cohorts 1 and 2 and Table 4 lists the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients in Study 1 Cohorts 1 and 2.
Table 3. Adverse Reactions Observed in at Least 10% of Patients in Study 1 (Cohorts 1 and 2) (N=82) Adverse Reaction Any Grade (%) Grade ≥3 (%) Blood and Lymphatic System Disorders Coagulopathy Includes multiple related terms. 10 2 Cardiac Disorders Tachycardias 45 0 Bradycardias 10 0 Non-ventricular Arrhythmias 10 4 Gastrointestinal Disorders Nausea 35 1 Constipation 29 0 Diarrhea 28 5 Abdominal pain 17 0 Oral pain 16 0 Vomiting 13 0 Dysphagia 10 2 General Disorders and Administration Site Conditions Fever 94 15 Fatigue 48 1 Chills 41 0 Edema 35 2 Pain 17 2 Immune System Disorders Cytokine release syndrome 91 18 Hypogammaglobulinemia 16 1 Infections and Infestations Infection with pathogen unspecified 43 24 Viral infections 18 4 Bacterial infections 13 6 Metabolism and Nutrition Disorders Decreased appetite 26 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain 37 2 Motor dysfunction Motor dysfunction includes asthenia, intensive care acquired weakness, mobility decreased, muscle twitching, muscular weakness, myopathy.
17 4 Nervous System Disorders Encephalopathy Encephalopathy includes encephalopathy, altered state of consciousness, amnesia, balance disorder, cognitive disorder, confusional state, disturbance in attention, dysgraphia, dyskinesia, memory impairment, mental status changes, neurotoxicity, somnolence. 51 24 Tremor 38 2 Headache 35 1 Aphasia 20 7 Dizziness Dizziness includes dizziness, presyncope, syncope. 18 6 Neuropathy Neuropathy includes hyperaesthesia, neuropathy peripheral, paraesthesia, paraesthesia oral.
13 2 Psychiatric Disorders Insomnia 21 0 Delirium Delirium includes delirium, agitation, disorientation, hallucination, hypomania, irritability, nervousness, personality change. 18 5 Anxiety 16 0 Renal and Urinary Disorders Renal insufficiency 18 9 Urine output decreased 11 1 Respiratory, Thoracic and Mediastinal Disorders Hypoxia 40 20 Cough 38 0 Dyspnea 24 6 Pleural effusion 21 5 Skin and Subcutaneous Tis…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.3Females and Males of Reproductive Potential 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.
8.4Pediatric Use The safety and efficacy of TECARTUS have not been established in pediatric patients.
8.5Geriatric Use 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.
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of TECARTUS have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action TECARTUS, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
12.2Pharmacodynamics After TECARTUS infusion, pharmacodynamic responses were evaluated over a four-week interval by measuring transient elevation of cytokines, chemokines, and other molecules in blood. Levels of cytokines and chemokines such as IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ, and sIL2Rα were analyzed. Peak elevation was generally observed within 8 days after infusion.
The majority of serum analytes returned to baseline levels by Week 4; however, ferritin, IFN-γ, IL-6, and IL-15 remained elevated ≥ 2-fold relative to baseline at Week 4. Due to the on-target effect of TECARTUS, a period of B cell aplasia is expected.
12.3Pharmacokinetics Following infusion (target dose of 2 × 10 6 anti-CD19 CAR T cells/kg) of TECARTUS in Study 1, anti-CD19 CAR T cells exhibited an initial rapid expansion followed by a decline to near baseline levels by 3 months. Peak levels of anti-CD19 CAR T cells occurred within the first 15 days after TECARTUS infusion. Following infusion (target dose of 1 × 10 6 anti-CD19 CAR T cells/kg) of TECARTUS in Study 2 (Phase 2), anti-CD19 CAR T cells exhibited an initial rapid expansion followed by a decline to near baseline levels by 6 months.
Median anti-CD19 CAR T cell time to peak was 15 days after TECARTUS infusion. Description of Pharmacokinetics in Adult r/r MCL In Study 1 Cohort 1, the number of anti-CD19 CAR T cells in blood was associated with objective response [complete remission (CR) or partial remission (PR)]. Median peak anti-CD19 CAR T cell level in responders was 102.4 cells/µL (range: 0.2 to 2589.5 cells/µL; n = 51), and in nonresponders was 12.0 cells/µL (range: 0.2 to 1364.0 cells/µL, n = 8).
The median AUC 0-28 in patients with an objective response was 1487.0 cells/µL•days (range: 3.8 to 2.77E+04 cells/µL•days; n = 51) versus 169.5 cells/µL•days in nonresponders (range: 1.8 to 1.17E+04 cells/µL•days; n = 8). In Study 1 Cohort 3 , median peak anti-CD19 CAR T cell level in responders [patients who achieved complete remission (CR) or partial remission (PR)] was 72.9 cells/μL (range: 0.5 to 1874.5 cells/μL; n = 77), and in nonresponders was 288.8 cells/μL (range: 1.32 to 912.6 cells/μL, n = 7). The median AUC 0-28 in patients with an objective response was 941.53 cells/μL•days (range: 8.8 to 1.63E+04 cells/μL•days; n = 77) versus 2141.4 cells/μL•days in nonresponders (range: 14.4 to 1.02E+04 cells/μL•days; n = 7).
In Study 1 Cohort 1, median peak anti-CD19 CAR T cell and AUC 0-28 levels in patients who received neither corticosteroids nor tocilizumab (peak: 24.7 cells/μL; AUC 0-28 : 360.4 cells/μL•days, n = 18) was similar to patients who received corticosteroids alone (peak: 24.2 cells/μL; AUC 0-28 : 367.8 cells/μL•days, n = 2); both groups were lower than patients who received tocilizumab alone (peak: 86.5 cells/μL; AUC 0-28 : 1188.9 cells/μL•days, n = 10); the highest exposure was in patients who received both corticosteroids and tocilizumab (peak: 167.2 cells/μL; AUC 0-28 : 1996.0 cells/μL•days, n = 37).
In Study 1 Cohort 3, median peak anti-CD19 CAR T cell and AUC 0-28 levels were lowest in patients who received neither corticosteroids nor tocilizumab (peak: 16.9 cells/μL; AUC 0-28 : 131.4 cells/μL•days, n = 13). Median peak anti-CD19 CAR T cell and AUC 0-28 levels in patients who received tocilizumab alone (peak 61.7 cells/ µL; AUC 0-28 : 594.3 cells/μL•days, n=8) were higher than patients who received neither cor…
🧬 Mechanism of Action ▾
12.1Mechanism of Action TECARTUS, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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. Indication Infusion Bag NDC number Metal Cassette NDC number MCL 71287-219-01 71287-219-02 ALL 71287-220-01 71287-220-02 Each TECARTUS infusion bag is individually packed in a metal cassette. TECARTUS is supplied in a liquid nitrogen dry shipper at ≤ -150°C.
Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt. At the treatment center, store TECARTUS frozen at ≤ -120°C (in a mechanical freezer or in the vapor phase of liquid nitrogen) up to the labeled expiration date. TECARTUS may be transferred from vapor phase of liquid nitrogen to mechanical freezer storage at ≤ -120°C only once and cannot be transferred back.
TECARTUS may be stored at the treatment center for a single time at -80°C (+/- 10°C), for up to 90 days, and not exceeding the labeled expiration date. Do not return TECARTUS to storage at ≤ -120°C after storage at -80°C. Thaw before using [see Dosage and Administration (2) ].
📦 Storage and Handling ▾
Each TECARTUS infusion bag is individually packed in a metal cassette. TECARTUS is supplied in a liquid nitrogen dry shipper at ≤ -150°C. Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt.
At the treatment center, store TECARTUS frozen at ≤ -120°C (in a mechanical freezer or in the vapor phase of liquid nitrogen) up to the labeled expiration date. TECARTUS may be transferred from vapor phase of liquid nitrogen to mechanical freezer storage at ≤ -120°C only once and cannot be transferred back. TECARTUS may be stored at the treatment center for a single time at -80°C (+/- 10°C), for up to 90 days, and not exceeding the labeled expiration date.
Do not return TECARTUS to storage at ≤ -120°C after storage at -80°C. Thaw before using [see Dosage and Administration (2) ].
📋 Description ▾
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. The anti-CD19 CAR T cells are expanded and infused back into the patient, where they can recognize and eliminate CD19-expressing target cells.
TECARTUS is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells and activated with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, then transduced with a replication-incompetent retroviral vector containing the anti-CD19 CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved.
The manufacture of TECARTUS includes a T cell enrichment step that may reduce the likelihood of circulating CD19-expressing tumor cells in patients' leukapheresis material driving the activation, expansion, and exhaustion of the anti-CD19 CAR T cells during the ex vivo manufacturing process. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag. The product is thawed prior to infusion [see Dosage and Administration (2.2) , How Supplied/Storage and Handling (16) ] .
In addition to T cells, TECARTUS may contain natural killer (NK) cells. The formulation contains CryoStor (dimethyl sulfoxide [DMSO], final concentration, 5%), sodium chloride (NaCl), and Human Serum Albumin (HSA).
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Ensure that patients understand the risk of manufacturing failure (4% in clinical trial). In case of a manufacturing failure, a second manufacturing of TECARTUS may be attempted.
In addition, while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period. Advise patients to seek immediate attention for any of the following: Cytokine Release Syndrome (CRS) - Signs or symptoms associated with CRS, including fever, chills, fatigue, tachycardia, nausea, hypoxia, and hypotension [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Neurologic Toxicities - Signs or symptoms associated with neurologic events, including encephalopathy, seizures, changes in level of consciousness, speech disorders, tremors, and confusion [see Warnings and Precautions (5.2) and Adverse Reactions (6) ] .
Severe Infections - Signs or symptoms associated with infection [see Warnings and Precautions (5.5) and Adverse Reactions (6) ] . Prolonged Cytopenias - Signs or symptoms associated with bone marrow suppression, including neutropenia, anemia, thrombocytopenia, or febrile neutropenia [see Warnings and Precautions (5.6) and Adverse Reactions (6) ]. Secondary Malignancies - Secondary malignancies, including T cell malignancies, have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies [see Boxed Warning , Warnings and Precautions (5.8) , Adverse Reactions (6.2) ] .
Advise patients of the need to: Avoid driving for at least 2 weeks. Contact Kite at 1-844-454-KITE (5483) if they are diagnosed with a secondary malignancy [see Warnings and Precautions (5.8) ] .
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: April 2026 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.
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 over-the-counter medicines, vitamins, and herbal supplements.
How will I receive TECARTUS? 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 3 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 daily for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 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 should I avoid after receiving TECARTUS?
Avoid driving for at least 2 weeks after you get TECARTUS. Do not donate blood, organs, tissues, or cells for transplantation. What are the possible or reasonably likely side effects of TECARTUS?
The most common side effects of TECARTUS 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 increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this. These are not all the possible side effects of TECARTUS.
Call your healthcare provider about any side effects t…