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Tisagenlecleucel

Kymriah · ATC code L01XL04

Also known as: Tisagenlesel

Key facts
Active substance
Tisagenlecleucel
ATC code
L01XL04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-28

Key facts

Tisagenlecleucel is a CD19-directed CAR T-cell therapy made from the patient's own T cells modified with a lentiviral vector. It is used for certain relapsed or refractory B-cell leukaemias and lymphomas.

What it is used for

  • Paediatric and young adult patients up to and including 25 years of age with B-cell ALL that is refractory, in relapse post-transplant or in second or later relapse.
  • Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • Adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Dosing

  • Kymriah (dispersion for infusion): autologous use only, as a single dose in a qualified treatment centre; manufacture usually takes about 3-4 weeks.
  • B-cell ALL: 50 kg and below 0.2 to 5 × 10⁶ CAR-positive viable T cells per kg; above 50 kg 0.1 to 2.5 × 10⁸ cells (non-weight based).
  • DLBCL and FL: 0.6 to 6 × 10⁸ CAR-positive viable T cells (non-weight based).
  • Preceded by lymphodepleting chemotherapy (e.g. fludarabine and cyclophosphamide in ALL); infuse 2 to 14 days after its completion for ALL and DLBCL, 2 to 6 days for FL.
  • At least one dose of tocilizumab must be available before infusion; patients should stay within 2 hours of travel of a qualified facility for at least 4 weeks after infusion.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Contraindications of the lymphodepleting chemotherapy must be considered.

Important warnings

  • Cytokine release syndrome (CRS), including fatal events, occurs frequently, usually within the first days after infusion; managed e.g. with tocilizumab and corticosteroids.
  • Neurological adverse reactions (ICANS) such as encephalopathy, confusional state or delirium, sometimes severe; no driving or operating machines for 8 weeks after infusion.
  • Infections, prolonged cytopenias, hypogammaglobulinaemia; HBV reactivation can occur.
  • Secondary malignancies including of T-cell origin; monitor life-long.
  • Delay infusion with unresolved serious reactions from prior chemotherapy, active uncontrolled infection or active GVHD.

Side effects

  • B-cell ALL: most common non-haematological cytokine release syndrome (75%), infections (70%), hypogammaglobulinaemia (49%), pyrexia (43%) and decreased appetite (28%).
  • Very commonly decreased white blood cells, haemoglobin, neutrophils, lymphocytes and platelets.
  • For adverse reactions in DLBCL and FL see the full text.

Interactions

  • No interaction studies. Live vaccines not recommended for at least 6 weeks before lymphodepleting chemotherapy, during treatment and until immune recovery.
  • GM-CSF not recommended during the first 3 weeks after infusion or until CRS has resolved.

Pregnancy and breastfeeding

  • Verify pregnancy status before treatment; for contraception see the lymphodepleting chemotherapy information. For pregnancy and breast-feeding see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • KymriahNovartis Europharm Limited · EMEA/H/C/004090

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Kymriah
Liechtenstein
Kymriah
Norway
Kymriah

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

  1. European Medicines Agency. Kymriah – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.