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 →
Kymriah, one of the first CAR T-cell therapies (on the U.S. market since about 2017, not available generically), reprograms a patient's own immune cells to hunt leukemia and lymphoma cells carrying a marker called CD19, and is given as one IV infusion after other treatments fail. It is demanding, since most people get cytokine release syndrome (an immune overreaction causing fever and low blood pressure) and blood counts can stay low for weeks. The boxed warning covers that syndrome, serious brain effects like confusion or seizures, and rare new T-cell cancers, so stay near the treatment center for at least 2 weeks and treat fever or confusion as an emergency.
Clinical pearls
- Some HIV blood tests can read falsely positive after Kymriah, so tell anyone ordering an HIV test that you received it.
- Skip live vaccines from at least 6 weeks before the preparatory chemotherapy until your immune system has recovered.
- Do not drive for at least 2 weeks after the infusion, because confusion or seizures can occur.
- Avoid steroids taken just to prevent reactions before the infusion, since they may blunt how well Kymriah works.
⚠️ 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.
Patient information guide A plain-language walkthrough of Tisagenlecleucel Injection, written from its FDA label.
What Tisagenlecleucel Injection is used for
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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 Tisagenlecleucel Injection works
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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.
Tisagenlecleucel Injection dosage
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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.
Dosing details from the FDA-approved label
From the Tisagenlecleucel Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (up to 25 years of age), patients 50 kg or less
- 0.2 to 5.0 x 10^6 CAR-positive viable T cells per kg body weight intravenously
- Based on patient weight reported at the time of leukapheresis; lymphodepleting chemotherapy: fludarabine 30 mg/m2 intravenously daily for 4 days and cyclophosphamide 500 mg/m2 intravenously daily for 2 days starting with the first dose of fludarabine; infuse KYMRIAH 2 to 14 days after completion
- Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (up to 25 years of age), patients above 50 kg
- 0.1 to 2.5 x 10^8 total CAR-positive viable T cells (non-weight based) intravenously
- Based on patient weight reported at the time of leukapheresis
- Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma
- 0.6 to 6.0 x 10^8 CAR-positive viable T cells intravenously
- Lymphodepleting chemotherapy: fludarabine 25 mg/m2 intravenously daily for 3 days and cyclophosphamide 250 mg/m2 intravenously daily for 3 days starting with the first dose of fludarabine; alternate: bendamustine 90 mg/m2 intravenously daily for 2 days; infuse 2 to 11 days (r/r DLBCL) or 2 to 6 days (r/r FL) after completion
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Administer a lymphodepleting regimen if needed before infusion of KYMRIAH. ( 2.2) Do NOT use a leukodepleting filter. ( 2.2 ) Verify the patient’s identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and an H1-antihistamine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of KYMRIAH is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. Pediatric and Young Adult B-cell ALL (up to 25 years of age) • For patients 50 kg or less, administer 0.2 to 5.0 x 10 6 CAR-positive viable T cells per kg body weight intravenously. ( 2.1 ) • For patients above 50 kg, administer 0.1 to 2.5 x 10 8 total CAR-positive viable T cells (non-weight based) intravenously. ( 2.1 ) Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma • Administer 0.6 to 6.0 x 10 8 CAR-positive viable T cells intravenously. ( 2.1 ) Note: The patient identifier number may be preceded by the letters DIN or Aph ID. Figure 1. KYMRIAH Infusion Bag 2.1 Recommended Dose For autologous use only. For intravenous use only. Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia KYMRIAH is provided as a single-dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells. Based on the patient weight reported at the time of leukapheresis: - Patients 50 kg or less: administer 0.2 to 5.0 x 10 6 CAR-positive viable T cells per kg body weight. - Patients above 50 kg: administer 0.1 to 2.5 x 10 8 CAR-positive viable T cells. Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma KYMRIAH is provided as a single-dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells. - For adult patients: administer 0.6 to 6.0 x 10 8 CAR-positive viable T cells. 2.2 Administration Preparing Patient for KYMRIAH Administration with Lymphodepletion - Confirm availability of KYMRIAH prior to starting the lymphodepleting regimen. Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Lymphodepleting chemotherapy: Fludarabine (30 mg/m 2 intravenously daily for 4 days) and cyclophosphamide (500 mg/m 2 intravenously daily for 2 days starting with the first dose of fludarabine).
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Tisagenlecleucel Injection side effects
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Because Kymriah activates the immune system intensely, side effects can be significant — the most common ones include:
Common side effects
- Cytokine release syndrome (CRS) — fever, low blood pressure, low oxygen levels
- Infections (bacterial, viral, or fungal)
- Low immunoglobulin (antibody) levels
- Fever and fatigue
- Headache
- Nausea, diarrhea, and vomiting
- Low blood cell counts (neutropenia, thrombocytopenia)
- Swelling (edema)
- Neurological effects — headache, confusion, encephalopathy (brain dysfunction), delirium, tremor
- Fatigue and decreased appetite
When to get medical help
- Get emergency help immediately for high fever, difficulty breathing, rapid heart rate, or very low blood pressure — these can be signs of cytokine release syndrome (CRS), which can be life-threatening.
- Seek immediate care for confusion, memory problems, seizures, slurred speech, or loss of consciousness — these may be signs of serious neurological toxicity.
- Call your doctor right away for signs of serious infection — prolonged fever, chills, or feeling very unwell.
- Tell your care team if you develop new or unusual symptoms weeks or months after infusion — rare T cell malignancies (secondary cancers) have been reported.
- Contact your doctor for signs of HLH (hemophagocytic lymphohistiocytosis/macrophage activation syndrome), a rare but life-threatening immune reaction — symptoms include prolonged high fever, enlarged spleen, and organ dysfunction.
- Report any new bleeding, severe bruising, or prolonged low blood counts after treatment.
Seek emergency care immediately for high fever, difficulty breathing, confusion, or seizures — these may signal serious CRS or neurological toxicity that requires urgent treatment.
Tisagenlecleucel Injection warnings and precautions
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- 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.
Tisagenlecleucel Injection interactions
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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.
Interactions listed in the FDA-approved label
From the Tisagenlecleucel Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- HIV nucleic acid tests (NATs): HIV and the lentivirus used to make KYMRIAH have limited, short spans of identical genetic material (RNA), so some commercial HIV NATs may yield false-positive results in patients who have received KYMRIAH.
Read the label’s full interactions text
7 DRUG INTERACTIONS HIV and the lentivirus used to make KYMRIAH have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests (NATs) may yield false-positive results in patients who have received KYMRIAH.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tisagenlecleucel Injection
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- 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.
What Tisagenlecleucel Injection does in the body
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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.
How your body processes Tisagenlecleucel Injection
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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 Tisagenlecleucel Injection
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Store infusion bag(s) in a temperature-monitored system less than or equal to minus 120°C, e.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Tisagenlecleucel Injection: pharmacist answers to common questions
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?
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What side effects should I actually watch out for after I get Kymriah?
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Do I need to stay in the hospital after receiving Kymriah?
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Will Kymriah affect my immune system long-term?
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Is there any concern about pregnancy or having children after Kymriah?
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I heard there's a risk of getting a new cancer from this treatment — is that true?
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When was Tisagenlecleucel Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tisagenlecleucel Injection on HelloPharmacist
Tisagenlecleucel Injection forms and strengths (how it 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tisagenlecleucel Injection inactive ingredients by manufacturer.
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 on the U.S. market: products, makers and brands
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.
1 company lists 2 Tisagenlecleucel Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2017. Brand names on the directory include Kymriah; the rest are generics.
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 | ||||
| TISAGENLECLEUCEL 2000000 1 | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
| TISAGENLECLEUCEL 60000000 1 | Intravenous | Novartis Pharmaceuticals Corporation | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Tisagenlecleucel Injection NDCs →
Tisagenlecleucel Injection side effects reported to the 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.
Tisagenlecleucel Injection FDA approval history
How Tisagenlecleucel Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Tisagenlecleucel Injection 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.
The FDA’s enforcement reports list no Tisagenlecleucel recalls since July 2021.
✅No Tisagenlecleucel recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
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.
Tisagenlecleucel Injection supply and 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.
Tisagenlecleucel Injection brand names
Tisagenlecleucel Injection is sold under one brand name in the FDA directory — Kymriah. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tisagenlecleucel Injection: manufacturers and labelers
One company lists Tisagenlecleucel Injection products with the FDA. By number of product records, the largest are Novartis Pharmaceuticals Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sources for this Tisagenlecleucel Injection page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →