Tisagenlecleucel Injection
Tisagenlecleucel (Kymriah) is a personalized, gene-modified cell therapy used to treat certain relapsed or treatment-resistant blood cancers, including acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and follicular lymphoma.
🧬 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 ▾
Kymriah carries a serious boxed warning for three major risks.
Cytokine release syndrome (CRS) — a potentially fatal immune system overreaction — has occurred in patients receiving Kymriah. Signs include high fever, difficulty breathing, and very low blood pressure. Kymriah must not be given to patients with active infections or inflammatory conditions. Severe CRS is treated with a medication called tocilizumab, sometimes combined with corticosteroids.
Serious neurological toxicities, including life-threatening reactions, have also occurred — sometimes at the same time as CRS. Patients must be monitored closely after infusion, and any neurological symptoms should be reported and treated immediately.
Secondary T cell malignancies (new cancers involving T cells) have occurred after treatment with Kymriah and similar CD19- or BCMA-directed cell therapies. These secondary cancers can appear within weeks of infusion and may be fatal. Lifelong monitoring is required.
📖 Tisagenlecleucel Injection: Patient Information Guide
A plain-language walkthrough of Tisagenlecleucel 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▾
Kymriah (tisagenlecleucel) is a CAR-T cell therapy — a personalized cancer treatment — approved for three specific blood cancer indications:
- Kymriah is approved for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory (did not respond to treatment) or in second or later relapse.
- Kymriah is approved for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — including high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma — after two or more prior lines of systemic therapy. It is not approved for primary central nervous system lymphoma.
- Kymriah is approved for adults with relapsed or refractory follicular lymphoma (FL) after two or more prior systemic therapies. This approval is under accelerated approval based on response rate and duration; continued approval depends on confirmatory trial results.
⚙️How it works▾
Kymriah works by harnessing your own immune system. Doctors collect your T cells (a type of immune cell) and send them to a lab, where they are genetically reprogrammed with a chimeric antigen receptor (CAR) — a specially designed protein that acts like a targeting system. This CAR directs your T cells to seek out and destroy cells that carry a surface protein called CD19, which is found on many blood cancer cells. A component called 4-1BB is built into the CAR to help the modified T cells multiply and survive in your body longer, extending the cancer-fighting effect over time.
💊How it's taken▾
Kymriah is given as a single, one-time intravenous infusion in a specialized medical facility — it is not taken at home. The dose is based on the number of living, CAR-positive T cells and, for younger patients, body weight. Before the infusion, most patients receive a short course of lymphodepleting chemotherapy to prepare the immune system; for the pediatric/young adult ALL indication, Kymriah is infused 2–14 days after that chemotherapy, while timing differs slightly for DLBCL and FL. There is no food restriction specific to the infusion, but follow all pre-treatment instructions from your care team exactly.
🤒Side effects — in detail▾
Because Kymriah activates the immune system intensely, side effects can be significant — the most common ones include:
- Cytokine release syndrome (CRS) — fever, chills, low blood pressure, low oxygen
- Neurological effects — headache, confusion, encephalopathy (brain dysfunction), delirium, tremor
- Infections — bacterial, viral, and fungal
- Low immunoglobulin (antibody) levels
- Prolonged low blood counts — neutropenia and thrombocytopenia (low white cells and platelets)
- Fatigue and decreased appetite
- Nausea, vomiting, and diarrhea
- Swelling (edema) and low blood pressure
Seek emergency care immediately for high fever, difficulty breathing, confusion, or seizures — these may signal serious CRS or neurological toxicity that requires urgent treatment.
⚠️Warnings & precautions▾
- Cytokine release syndrome (CRS): A potentially fatal immune overreaction that occurred in the majority of patients in trials. Symptoms include high fever, very low blood pressure, and low oxygen. Kymriah must not be given during active infection or inflammatory conditions. Tocilizumab and/or corticosteroids are used to treat severe CRS.
- Neurological toxicities: Serious or life-threatening brain-related effects occurred in a large proportion of patients, sometimes alongside CRS. Symptoms include confusion, encephalopathy, seizures, and aphasia (difficulty speaking). Monitor for at least 2 weeks after infusion.
- Secondary T cell malignancies: New cancers involving T cells have been reported after Kymriah and similar therapies — sometimes within weeks of infusion and potentially fatal. Lifelong monitoring is required.
- HLH/Macrophage Activation Syndrome: A rare but life-threatening immune condition has occurred in some patients, including fatal cases.
- Serious infections: Life-threatening infections, including opportunistic infections like progressive multifocal leukoencephalopathy (a serious brain infection), have occurred.
- Prolonged low blood counts: Neutropenia and thrombocytopenia lasting weeks after infusion increase infection and bleeding risk.
- Low antibody levels (hypogammaglobulinemia): B-cell depletion can lower your body's ability to fight infection; immunoglobulin replacement may be needed.
🔀What it interacts with▾
Kymriah has a few important interactions and interferences to know about:
- HIV nucleic acid tests (NATs): Kymriah is made using a lentivirus that shares some genetic material with HIV. Some commercial HIV NAT tests may show a false-positive result — always inform providers that you have received Kymriah before HIV testing.
- Live vaccines: Live vaccines are not recommended for at least 6 weeks before lymphodepleting chemotherapy, during treatment, or until immune recovery — they may pose an infection risk when your immune system is suppressed.
- Systemic corticosteroids (preventive use): Taking steroids as a preventive measure before infusion is not recommended because they may reduce how well Kymriah works.
- Myeloid growth factors (especially GM-CSF): These are not recommended in the first 3 weeks after infusion or until CRS resolves, as they may worsen CRS.
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▾
- You must not receive Kymriah if you have an active infection or active inflammatory condition — treatment must wait until these are resolved.
- Screening for hepatitis B, hepatitis C, and HIV is required before your cells are collected for manufacturing.
- Tell your doctor if you are pregnant — Kymriah is not recommended during pregnancy because it may harm the fetus. Discuss contraception and pregnancy planning with your care team.
- If you are breastfeeding, discuss the risks with your doctor — it is not known whether Kymriah passes into breast milk.
- If you have a history of severe bladder bleeding (hemorrhagic cystitis) with cyclophosphamide, tell your team — an alternate pre-treatment regimen using bendamustine may be used instead.
- Kymriah is approved for children as young as 2 years with ALL, but safety and efficacy in children with DLBCL or FL have not been established.
- Safety and effectiveness in patients 65 years and older have not been fully established for ALL; clinical studies did not include enough older patients to draw firm conclusions.
- Newborns of mothers who received Kymriah should have their immunoglobulin levels checked, as low antibody levels may be passed from mother to infant.
📡Pharmacodynamics — effects in the body▾
Because Kymriah targets CD19 — a marker found on both cancerous and healthy B cells — it causes B-cell aplasia (a drop in or elimination of normal B cells) as an expected on-target effect. In pediatric ALL patients with an ongoing response at 24 months, 88% had no detectable B cells. This B-cell depletion leads to lower immunoglobulin (antibody) levels, increasing the need for monitoring and possible replacement therapy. In some DLBCL patients followed long-term, B-cell levels recovered after infusion, while ongoing responders in the DLBCL and FL groups had no detectable B cells at 24 months.
🔬Pharmacokinetics — how your body processes it▾
After infusion, Kymriah's modified T cells expand rapidly in the body, reaching peak levels at roughly 10 days in most patient groups, then gradually declining. In pediatric ALL patients, Kymriah was detectable in both blood and bone marrow beyond 2 years; the cells distribute heavily into the bone marrow (up to 69% of blood levels by Month 6). In adults with DLBCL, the cells were detectable in peripheral blood for up to 18 months and in bone marrow up to 9 months. In adults with follicular lymphoma, cells were detected in peripheral blood for up to 18 months and in bone marrow for up to 3 months in responding patients.
📦How to store it▾
Store infusion bag(s) in a temperature-monitored system less than or equal to minus 120°C, e.
📄 Written from Tisagenlecleucel 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 Tisagenlecleucel Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Kymriah and how is it different from regular chemotherapy? ▾
What side effects should I actually watch out for after I get Kymriah? ▾
Do I need to stay in the hospital after receiving Kymriah? ▾
Will Kymriah affect my immune system long-term? ▾
Is there any concern about pregnancy or having children after Kymriah? ▾
I heard there's a risk of getting a new cancer from this treatment — is that true? ▾
When was Tisagenlecleucel Injection first available? ▾
💬 Answers drafted from Tisagenlecleucel 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 Tisagenlecleucel Injection comes
Tisagenlecleucel 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
- Kymriah is used for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that has not responded to treatment or has relapsed at least twice.
- Kymriah is used for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies — not for primary CNS lymphoma.
- Kymriah is used for adults with relapsed or refractory follicular lymphoma (FL) after two or more prior systemic therapies (approved under accelerated approval).
- Kymriah is given as a single intravenous infusion in a specialized healthcare facility after a course of lymphodepleting chemotherapy.
- Kymriah is for autologous use only — it is made from the patient's own T cells and must be matched to that specific patient before infusion.
- Patients must be pre-medicated with acetaminophen and an H1-antihistamine approximately 30–60 minutes before Kymriah infusion; prophylactic systemic corticosteroids should be avoided.
- After receiving Kymriah, patients must remain within proximity of a healthcare facility for at least 2 weeks and should avoid driving during that period.
📊 Tisagenlecleucel Injection across the U.S. market
How Tisagenlecleucel 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 Tisagenlecleucel Injection products
A representative set of FDA-listed product records for Tisagenlecleucel 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 | ||||
| 2000000 1 | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
| 2000000 1-Jan | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
| TISAGENLECLEUCEL 2000000 1 | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
| 60000000 1 | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
| 60000000 1-Jan | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
| TISAGENLECLEUCEL 60000000 1 | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Tisagenlecleucel 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 Tisagenlecleucel 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 Tisagenlecleucel 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 Tisagenlecleucel 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 1986438 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1986441In current FDA listings
Look up RxCUI 1986438 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 Tisagenlecleucel 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
Tisagenlecleucel 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. Novartis Pharmaceuticals Corporation 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.