epcoritamab
Tepkinly · ATC code L01FX27
Also known as: Epkoritamab
- Key facts
- Active substance
- epcoritamab
- ATC code
- L01FX27
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tepkinly 4 mg/0.8 ml solution for injection · Tepkinly 48 mg solution for injection
- Marketing authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Information as of
- 2026-10-29
Key facts
Epcoritamab (Tepkinly) is a bispecific antibody that directs T cells against B-cell lymphoma cells; it is given by injection for relapsed or refractory B-cell lymphomas.
What it is used for
- Monotherapy of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults after two or more lines of systemic therapy.
- Relapsed or refractory follicular lymphoma in adults in combination with lenalidomide and rituximab.
- Monotherapy of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Dosing
- Step-up dosing in 28-day cycles, full dose 48 mg. DLBCL (monotherapy): 0.16 mg and 0.8 mg in the first cycle, then 48 mg; follicular lymphoma: an additional 3 mg intermediate step.
- Monotherapy: weekly in cycles 2-3, every two weeks in cycles 4-9, every four weeks from cycle 10, until progression or unacceptable toxicity.
- With lenalidomide and rituximab (follicular lymphoma): weekly in cycles 2 and 3, every four weeks in cycles 4 to 12, for 12 cycles in total.
- Premedication including corticosteroids to reduce the risk of cytokine release syndrome, and adequate hydration in the first cycle; see the full text for details.
- At least 1 dose of tocilizumab must be available before cycle 1; administered only under supervision of professionals qualified in anti-cancer therapy.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Cytokine release syndrome (CRS), which may be life-threatening or fatal, mostly in cycle 1 after the first full dose; common signs are pyrexia, hypotension and hypoxia.
- Immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal events, e.g. aphasia, altered consciousness or seizures; major influence on the ability to drive.
- Serious or fatal infections; avoid in patients with clinically significant active systemic infection.
- Haemophagocytic lymphohistiocytosis and tumour lysis syndrome can occur.
Side effects
- Most common (≥ 20%, monotherapy): CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia and diarrhoea.
- Serious adverse reactions occurred in 50% of patients, most often CRS (34%); fatal adverse reactions in 3.7% (mainly pneumonia).
Interactions
- No studies; transiently raised cytokines may suppress CYP450 enzymes - therapeutic monitoring should be considered for CYP450 substrates with a narrow therapeutic index.
Pregnancy and breastfeeding
- May cause foetal harm; not recommended in pregnancy. Contraception for at least 4 months after the last dose.
- Breast-feeding should be discontinued during treatment and for at least 4 months after the last dose.
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)
- TepkinlyAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/005985
Source: European Medicines Agency (EMA), product information
Turkey
- TepkinlyABBVİE TIBBİ İLAÇLAR SAN. VE TİC. LTD. ŞTİ. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Tepkinly
- Liechtenstein
- Tepkinly
- Norway
- Tepkinly
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. Tepkinly – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-29 · 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.