tislelizumab
Tevimbra · ATC code L01FF09
- Key facts
- Active substance
- tislelizumab
- ATC code
- L01FF09
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tevimbra 100 mg concentrate for solution for infusion
- Marketing authorisation holder
- Beone Medicines Ireland Limited
- Information as of
- 2026-10-28
Key facts
Tislelizumab is a humanised monoclonal antibody of the PD-1 inhibitor class. It is used in adults with various lung, gastric, oesophageal and nasopharyngeal cancers.
What it is used for
- Non-small cell lung cancer (NSCLC): neoadjuvant with platinum chemotherapy then adjuvant in resectable NSCLC at high risk of recurrence; first-line with chemotherapy (non-squamous with PD-L1 ≥ 50% and no EGFR/ALK mutation, and squamous); monotherapy after platinum-based therapy (Tevimbra).
- Extensive-stage small cell lung cancer: first-line with etoposide and platinum.
- HER-2-negative gastric or gastro-oesophageal junction adenocarcinoma (TAP score ≥ 5%) and oesophageal squamous cell carcinoma: first-line with chemotherapy; oesophageal cancer also as monotherapy after platinum chemotherapy.
- Nasopharyngeal carcinoma: first-line with gemcitabine and cisplatin.
Dosing
- Intravenous infusion: 200 mg every 3 weeks or 400 mg every 6 weeks, as monotherapy or with chemotherapy (given before chemotherapy on the same day).
- Resectable NSCLC: neoadjuvant 200 mg every 3 weeks with chemotherapy for 3 or 4 cycles, then adjuvant 400 mg every 6 weeks for up to 8 cycles.
- Treat until progression or unacceptable toxicity; dose reductions are not recommended - withhold or discontinue depending on the adverse reaction (see the full text).
- Where specified in the indication, select patients with a validated PD-L1 test.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
Important warnings
- Immune-related adverse reactions, including fatal ones and also after the last dose, e.g. pneumonitis, hepatitis, colitis, skin reactions up to SJS/TEN, endocrinopathies, myocarditis.
- Patients must receive a Patient Card; management usually by interruption and corticosteroids.
- Infusion-related reactions may occur.
- Increased risk of rejection in solid organ transplant recipients.
Side effects
- Monotherapy, most common (≥ 20%): anaemia (27.7%), AST increased (24.7%), fatigue (24.6%) and ALT increased (22.0%).
- Monotherapy, most common grade 3/4: anaemia (4.8%), AST increased (3.7%), pneumonia (3.6%), hyponatraemia (2.9%).
- 1.0% of patients had adverse reactions leading to death (including pneumonia, pneumonitis, hepatitis). See the full text for combination therapy data.
Interactions
- As a monoclonal antibody it is not metabolised by CYP450; no pharmacokinetic interactions are expected.
- Avoid systemic corticosteroids (except low doses up to 10 mg/day prednisone) and other immunosuppressants before starting; they may be used after starting to treat immune-related reactions.
Pregnancy and breastfeeding
- Can cause foetal harm; effective contraception during treatment and for at least 4 months after the last dose.
- 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.
Common questions – ask Medelix
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)
- TevimbraBeone Medicines Ireland Limited · EMEA/H/C/005919
Source: European Medicines Agency (EMA), product information
Brand names in 2 more European countries
- Iceland
- Tevimbra
- Norway
- Tevimbra
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.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Tevimbra – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tevimbra-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.