Axicabtagene Ciloleucel Injection
Axicabtagene ciloleucel is a personalized CAR T-cell therapy used to treat certain types of relapsed or hard-to-treat large B-cell lymphoma and follicular lymphoma 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 ▾
Yescarta carries a serious boxed warning for three major risks:
Cytokine Release Syndrome (CRS): A powerful and potentially life-threatening immune reaction occurred in most patients who received Yescarta. Symptoms include high fever, severe low blood pressure, and difficulty breathing. Yescarta must NOT be given to anyone with an active infection or inflammatory condition. Severe CRS is treated with a medication called tocilizumab, sometimes combined with steroids.
Neurologic toxicities: Serious and sometimes fatal brain and nervous system reactions — including confusion, seizures, and brain swelling — have occurred, sometimes at the same time as CRS or after it has resolved. Patients must be monitored closely after treatment.
Secondary T-cell malignancies: New T-cell cancers, including some that were fatal, have been reported after treatment with CAR T-cell therapies targeting CD19 (including Yescarta). These can appear within weeks of the infusion. Patients require lifelong monitoring for new cancers after treatment.
📖 Axicabtagene Ciloleucel Injection: Patient Information Guide
A plain-language walkthrough of Axicabtagene Ciloleucel 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▾
Yescarta (axicabtagene ciloleucel) is a CD19-directed CAR T-cell therapy approved for the following conditions in adults:
- Large B-cell lymphoma (LBCL) — early relapse or refractory disease: Yescarta treats adults whose LBCL did not respond to first-line chemoimmunotherapy, or whose cancer came back within 12 months of completing it.
- Large B-cell lymphoma — later lines of therapy: Yescarta treats adults with relapsed or refractory LBCL after two or more prior systemic treatments, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
- Follicular lymphoma (FL): Yescarta treats adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This approval is under accelerated approval based on response rate; continued approval may depend on confirmatory trial results.
⚙️How it works▾
Yescarta is built from your own T cells — a type of white blood cell that normally fights infection. Your cells are collected, sent to a lab, and genetically modified to carry a chimeric antigen receptor (CAR) that targets CD19, a protein on the surface of many lymphoma cells. When these modified CAR T cells are infused back into you, they recognize, attach to, and destroy CD19-expressing cancer cells. The modified cells also multiply inside your body, amplifying the attack. Because normal B cells also carry CD19, they are affected too — leading to a temporary drop in healthy B cells, which your immune team will monitor and manage.
💊How it's taken▾
Yescarta is given as a single, one-time intravenous infusion through a central venous line — it is not a pill or a repeated injection. Before the infusion, a short course of lymphodepleting chemotherapy is given to prepare your immune system. A premedication of acetaminophen and an antihistamine is given about one hour before the infusion to reduce the risk of reactions. After infusion, you must stay near a certified healthcare facility for at least two weeks and avoid driving for at least two weeks. Your care team will provide all specific timing and follow-up instructions.
🤒Side effects — in detail▾
The most common side effects of Yescarta include:
- Fever and chills
- Low blood pressure (hypotension)
- Rapid heart rate (tachycardia)
- Fatigue
- Confusion or difficulty thinking (encephalopathy)
- Headache
- Nausea, diarrhea, or decreased appetite
- Febrile neutropenia (fever with low white blood cell counts)
- Low oxygen levels (hypoxia)
- Tremor or dizziness
More serious reactions — including severe cytokine release syndrome (CRS), serious neurologic toxicities, life-threatening infections, and prolonged low blood counts — require immediate medical attention and ongoing monitoring by your care team.
⚠️Warnings & precautions▾
- Cytokine Release Syndrome (CRS): CRS occurred in 90% of NHL patients receiving Yescarta. It can range from fever and chills to life-threatening low blood pressure and breathing failure. It is treated with tocilizumab and/or corticosteroids. Report any fever, difficulty breathing, or dizziness right away.
- Neurologic toxicities (ICANS): Serious brain and nerve effects — including confusion, difficulty speaking, tremors, seizures, and brain swelling — occurred in up to 87% of LBCL patients. These can be fatal. Monitor closely for at least 2 weeks after infusion.
- Secondary T-cell malignancies: New T-cell cancers have occurred after CAR T-cell therapy with Yescarta. Some appeared within weeks and were fatal. Lifelong monitoring for new cancers is required.
- Serious infections: Severe infections — including fungal, bacterial, viral, and opportunistic infections — occurred in 17% of patients at Grade 3 or higher. Hepatitis B reactivation has also been reported.
- Prolonged low blood counts: Low white blood cells, platelets, and red blood cells can persist for several weeks after treatment, increasing risk of infection and bleeding.
- Hypogammaglobulinemia (low antibody levels): Low protective antibody levels were reported in 14% of patients, requiring monitoring and possible replacement therapy.
🔀What it interacts with▾
Your care team needs to know about everything you are taking before and after your Yescarta infusion:
- Live vaccines: Not recommended for at least 6 weeks before the preparatory chemotherapy, during treatment, or until immune recovery — the immune response to live vaccines is unpredictable after CAR T-cell therapy.
- Corticosteroids (e.g., dexamethasone, methylprednisolone): Used to manage CRS and neurologic toxicities; prophylactic use may affect the severity and timing of those reactions and should only be used as directed by your care team.
- Tocilizumab: Required on hand at all times during infusion and recovery; used to treat severe CRS — your team must confirm it is available before your infusion begins.
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 inflammatory disorder: Yescarta must NOT be given if you have an active, clinically significant infection or inflammatory condition.
- Hepatitis B: Screening for HBV, HCV, and HIV is required before cells are collected for manufacturing; HBV reactivation, including fatal cases, has occurred.
- History of CNS disorders or autoimmune disease: History of seizures, stroke, or autoimmune disease requiring systemic immunosuppression may affect eligibility — discuss with your doctor.
- Pregnancy: Yescarta is not recommended during pregnancy. If the modified cells cross the placenta, they may harm the fetus. Discuss pregnancy planning with your treating physician.
- Breastfeeding: It is not known whether Yescarta passes into breast milk; discuss the risks and benefits with your doctor.
- Women of reproductive potential: A pregnancy test is required before starting treatment.
- Children: The safety and effectiveness of Yescarta have not been established in pediatric patients.
- Older adults (65+): About 30% of clinical trial participants were 65 or older; no significant differences in safety or effectiveness were found compared to younger adults.
- Kidney or liver impairment: Formal studies in patients with hepatic or renal impairment have not been conducted.
📡Pharmacodynamics — effects in the body▾
After your Yescarta infusion, the modified CAR T cells trigger a wave of immune activity — including a rise in cytokines (immune signaling molecules like IL-6, IL-10, IFN-γ, and TNF-α) that peaks within the first 14 days and typically returns to baseline within 28 days. As an expected effect of targeting CD19, a period of B-cell aplasia (loss of normal B cells) follows the infusion — most patients have few or no detectable B cells in the months after treatment, though the majority see B-cell recovery by Month 24.
🔬Pharmacokinetics — how your body processes it▾
After infusion, Yescarta's CAR T cells rapidly expand in the body, reaching peak levels within 7 to 14 days, then declining to near-baseline levels by about 3 months. Higher peak cell levels and greater overall exposure (measured over the first 28 days) have been associated with better treatment responses in patients with large B-cell lymphoma. Age (21–80 years) and sex did not significantly affect how the CAR T cells expanded. Formal studies of how kidney or liver impairment affects Yescarta have not been conducted.
📦How to store it▾
store YESCARTA 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 Axicabtagene Ciloleucel 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 Axicabtagene Ciloleucel Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Yescarta and how is it different from regular chemotherapy? ▾
What are the most important side effects I should watch out for after treatment? ▾
Do I need to stay in the hospital after my Yescarta infusion? ▾
Can I get vaccines or take other medications while being treated with Yescarta? ▾
Is Yescarta safe if I'm pregnant or thinking about becoming pregnant? ▾
My doctor mentioned a risk of a new cancer forming after Yescarta — should I be worried? ▾
When was Axicabtagene Ciloleucel Injection first available? ▾
💬 Answers drafted from Axicabtagene Ciloleucel 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 Axicabtagene Ciloleucel Injection comes
Axicabtagene Ciloleucel 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
- Yescarta is used intravenously to treat adults with large B-cell lymphoma refractory to or relapsing within 12 months of first-line chemoimmunotherapy
- Yescarta is used intravenously to treat adults with relapsed or refractory large B-cell lymphoma after two or more prior lines of systemic therapy
- Yescarta is used intravenously to treat adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy (accelerated approval based on response rate)
- Yescarta is given as a single IV infusion over approximately 30 minutes, for autologous use only — it is made from the patient's own T cells
- Yescarta must be preceded by lymphodepleting chemotherapy (cyclophosphamide and fludarabine) given on the 5th, 4th, and 3rd days before infusion
- Yescarta must not be infused through a leukodepleting filter; central venous access is recommended
- After Yescarta infusion, patients must be monitored at least daily for 7 days and remain within proximity of a healthcare facility for at least 2 weeks
📊 Axicabtagene Ciloleucel Injection across the U.S. market
How Axicabtagene Ciloleucel 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 Axicabtagene Ciloleucel Injection products
A representative set of FDA-listed product records for Axicabtagene Ciloleucel 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. × 3 listings | BLA | View NDC → |
| 2000000 1/68 mL | Intravenous | Kite Pharma, Inc. × 2 listings | BLA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Axicabtagene Ciloleucel 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 Axicabtagene Ciloleucel 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 Axicabtagene Ciloleucel 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 Axicabtagene Ciloleucel 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 1987398 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1987401In current FDA listingsClinical drug / strength (SCD) 68 ML axicabtagene ciloleucel 2940000 CELLS/MLRxCUI 1987402
Look up RxCUI 1987398 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 Axicabtagene Ciloleucel 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
Axicabtagene Ciloleucel Injection belongs to the CD19-directed Chimeric Antigen Receptor 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.