Brexucabtagene Autoleucel Injection
Brexucabtagene autoleucel (Tecartus) is a personalized CAR T-cell therapy used to treat relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Tecartus carries serious boxed warnings for three major risks: cytokine release syndrome, neurologic toxicities, and secondary blood cancers.
Cytokine release syndrome (CRS) — a powerful, body-wide immune reaction — can be life-threatening. It has occurred in the vast majority of patients who received Tecartus. Signs include high fever, low blood pressure, and difficulty breathing. Tecartus must NOT be given to anyone with an active infection or inflammatory condition. If severe CRS develops, it is treated with a medicine called tocilizumab, sometimes combined with corticosteroids.
Neurologic toxicities — including confusion, difficulty speaking, and seizures — can also be life-threatening. They may happen at the same time as CRS or after CRS has resolved. Patients are monitored closely after infusion, and treatment with supportive care or corticosteroids may be needed.
Secondary T cell malignancies (new blood cancers involving T cells) have occurred in patients treated with CD19-directed CAR T-cell therapies like Tecartus. These can appear within weeks of infusion and may be fatal. Lifelong monitoring for new cancers is required.
📖 Brexucabtagene Autoleucel Injection: Patient Information Guide
A plain-language walkthrough of Brexucabtagene Autoleucel Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Brexucabtagene autoleucel is a CD19-directed CAR T-cell immunotherapy approved for two blood cancers in adults that have relapsed (come back) or are refractory (no longer responding to treatment).
- Tecartus (intravenous infusion) is approved for adults with relapsed or refractory mantle cell lymphoma (MCL) — a type of non-Hodgkin lymphoma
- Tecartus (intravenous infusion) is approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) — an aggressive cancer of the blood and bone marrow
⚙️How it works▾
Brexucabtagene autoleucel works by re-engineering your own immune cells to fight cancer. T cells are collected from your blood, genetically modified in a laboratory to express a chimeric antigen receptor (CAR) that targets a protein called CD19 — found on the surface of certain cancer cells — and then infused back into your body. Once inside, these reprogrammed CAR T cells recognize and bind to CD19-expressing cancer cells, triggering activation, rapid multiplication, and direct killing of those cells, while also releasing signaling proteins (cytokines) that amplify the immune response.
Because CD19 is also found on normal B cells (a type of immune cell), a period of B cell depletion is an expected result of treatment. This is monitored and managed by your care team.
💊How it's taken▾
Tecartus is given as a single, one-time intravenous infusion — there are no daily pills or repeated infusion cycles. In the days before your infusion, you will receive a short course of chemotherapy (fludarabine and cyclophosphamide) to prepare your immune system, followed by premedication with acetaminophen and an antihistamine before Tecartus is given. The dose is calculated based on your body weight and is prepared specifically from your own cells.
- The infusion is given through a central venous line (a catheter in a large vein) over approximately 30 minutes
- After infusion, you must stay near a healthcare facility for at least 2 weeks and avoid driving for at least 2 weeks
- Your care team will monitor you daily for at least 7 days after infusion and will guide all follow-up care
🤒Side effects — in detail▾
Most patients experience side effects after Tecartus infusion — many related to the immune system activating. Common reactions include:
- Fever and chills
- Low blood pressure (hypotension)
- Rapid heartbeat (tachycardia)
- Low oxygen levels (hypoxia)
- Fatigue
- Nausea, diarrhea, or constipation
- Tremor and headache
- Confusion or altered mental state (encephalopathy)
- Rash
- Muscle pain
Serious reactions — including life-threatening cytokine release syndrome (CRS) and neurologic toxicity — occurred in the majority of patients in clinical trials. These require immediate medical attention. Low blood counts lasting weeks after treatment are also common and will be monitored closely.
⚠️Warnings & precautions▾
- Cytokine release syndrome (CRS): Occurred in over 90% of patients. Can be life-threatening. Signs include high fever, low blood pressure, and difficulty breathing. Treated with tocilizumab with or without corticosteroids.
- Neurologic toxicity (ICANS): Occurred in 80–87% of patients. Can include confusion, difficulty speaking, tremors, or seizures. May occur alongside CRS or after it resolves. Can be severe or fatal.
- Severe infections: Occurred in more than 40% of patients. Includes bacterial, viral, and fungal infections. Hepatitis B reactivation is also a risk. Screening for HBV, HCV, and HIV is required before cell collection.
- Prolonged low blood counts (cytopenias): Low white blood cells, platelets, and red blood cells can persist for weeks after treatment. Regular blood count monitoring is required.
- HLH/MAS: A rare but life-threatening immune complication (hemophagocytic lymphohistiocytosis/macrophage activation syndrome) has occurred, mainly in ALL patients.
- Secondary malignancies: T cell cancers — including CAR-positive tumors — have developed after treatment. Lifelong cancer monitoring is required.
- Low antibody levels (hypogammaglobulinemia): Can increase infection risk; may require immunoglobulin replacement therapy.
🔀What it interacts with▾
There are limited traditional drug interactions with Tecartus itself, but two important considerations apply:
- Systemic corticosteroids (e.g., prednisone, dexamethasone): Routine preventive use before infusion is not recommended because these may reduce Tecartus's effectiveness. Corticosteroids are used only when directed by your team to manage CRS or neurologic toxicity.
- Live vaccines: Should not be given for at least 6 weeks before starting the lymphodepleting chemotherapy, during treatment, or until your immune system has sufficiently recovered — timing will be guided by your care team.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active infection or inflammation: Tecartus must not be given to anyone with a clinically significant active infection or inflammatory disorder
- HBV/HCV/HIV: Screening for hepatitis B, hepatitis C, and HIV is required before cells are collected; hepatitis B reactivation can be fatal
- Pregnancy: Tecartus is not recommended during pregnancy; the modified cells may cross the placenta and harm the fetus, including causing B cell depletion
- Breastfeeding: It is unknown if Tecartus is present in breast milk; weigh benefits and risks with your doctor
- Females of childbearing potential: A negative pregnancy test is required before starting treatment; discuss contraception with your care team
- Children: Safety and effectiveness have not been established in pediatric patients
- Older adults (65+): Have been treated with Tecartus without overall differences in safety or effectiveness, but continue to require close monitoring
📡Pharmacodynamics — effects in the body▾
After Tecartus is infused, the body's immune signaling molecules — including cytokines and chemokines like IL-6, IL-15, IFN-γ, and TNF-α — rise significantly in the blood, peaking within about 8 days of infusion. Most of these return to baseline levels within 4 weeks, though some remain elevated longer. Because Tecartus targets CD19, which is also present on normal B cells, a period of B cell depletion (aplasia) is an expected and monitored effect of treatment.
🔬Pharmacokinetics — how your body processes it▾
After infusion, the reprogrammed CAR T cells expand rapidly in the body, reaching peak levels within approximately 15 days. In patients treated for MCL, cell levels declined toward baseline by about 3 months; in ALL patients, they declined to near baseline by about 6 months. Higher levels of CAR T cell expansion were generally associated with better treatment responses. Gender did not significantly affect how the cells expanded or persisted in the body.
📦How to store it▾
store TECARTUS frozen at ≤ -120°C (in a mechanical freezer or in the vapor phase of liquid nitrogen) up to the labeled expiration date. at ≤ -120°C only once and cannot be transferred back.
📄 Written from Brexucabtagene Autoleucel Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Brexucabtagene Autoleucel Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Tecartus and how is it different from regular chemotherapy? ▾
What side effects should I be ready for, and which ones are serious enough to call about right away? ▾
Since this is made from my own cells, do I need to worry about rejection or my body fighting it? ▾
Can I drive or go home right after my infusion? ▾
Is it safe to get vaccinated or take other medications while I'm being treated? ▾
What if I want to get pregnant after this treatment? ▾
When was Brexucabtagene Autoleucel Injection first available? ▾
💬 Answers drafted from Brexucabtagene Autoleucel Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Brexucabtagene Autoleucel Injection comes
Brexucabtagene Autoleucel Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Tecartus is used to treat adults with relapsed or refractory mantle cell lymphoma (MCL)
- Tecartus is used to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
- Tecartus is given as a single, one-time intravenous infusion by a healthcare professional — never self-administered
- Tecartus must be preceded by a lymphodepleting chemotherapy regimen (cyclophosphamide and fludarabine) given in the days before infusion
- Tecartus is for autologous use only — it is made from the individual patient's own T cells and must be matched to that patient before infusion
- After Tecartus infusion, patients must remain near a healthcare facility for at least 2 weeks and should avoid driving for at least 2 weeks
📊 Brexucabtagene Autoleucel Injection across the U.S. market
How Brexucabtagene Autoleucel Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Brexucabtagene Autoleucel Injection products
A representative set of FDA-listed product records for Brexucabtagene Autoleucel Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 68 mL | Intravenous | Kite Pharma, Inc. × 4 listings | BLA | View NDC → |
| 1000000 1/68 mL | Intravenous | Kite Pharma, Inc. × 2 listings | BLA | View NDC → |
| 2000000 1/68 mL | Intravenous | Kite Pharma, Inc. × 2 listings | BLA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Brexucabtagene Autoleucel Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Brexucabtagene Autoleucel Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Brexucabtagene Autoleucel Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Brexucabtagene Autoleucel Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2387277 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 2387346In current FDA listingsClinical drug / strength (SCD) 68 ML brexucabtagene autoleucel 1471000 CELLS/MLRxCUI 257200268 ML brexucabtagene autoleucel 2940000 CELLS/MLRxCUI 2387347
Look up RxCUI 2387277 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Brexucabtagene Autoleucel Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Brexucabtagene Autoleucel Injection belongs to the Antineoplastic cell and gene therapy class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Kite Pharma, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.