Lurbinectedin
Zepzelca · ATC code L01XX69
Also known as: Lurbinektedin
- Key facts
- Active substance
- Lurbinectedin
- ATC code
- L01XX69
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ZEPZELCA 2 mg powder for concentrate for solution for infusion / ZEPZELCA 4 mg powder for concentrate for solution for infusion
- Marketing authorisation holder
- Pharma Mar S.A.
- Information as of
- 2026-10-28
Key facts
Lurbinectedin (Zepzelca) is an alkylating anticancer agent given by infusion with atezolizumab as maintenance treatment for extensive-stage small cell lung cancer.
What it is used for
- In combination with atezolizumab for maintenance treatment of adults with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction with atezolizumab, carboplatin and etoposide.
Dosing
- 3.2 mg/m2 every 21 days with atezolizumab until progression or unacceptable toxicity; on the same day atezolizumab is given first.
- Start only if neutrophils are at least 1.5 x 10⁹/L and platelets at least 100 x 10⁹/L.
- Dose reductions for adverse reactions to 2.6 mg/m2 and then 2.0 mg/m2, then stop.
- Moderate hepatic impairment or unavoidable strong or moderate CYP3A inhibitors: dose reduced by 50% (1.6 mg/m2).
- Antiemetic premedication before each infusion (intravenous dexamethasone 8 mg and ondansetron 8 mg); primary G-CSF prophylaxis is recommended.
- Should not be given in severe renal impairment (CrCL < 30 mL/min); not recommended with AST or ALT > 3 × ULN.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Breastfeeding.
Important warnings
- Severe and life-threatening myelosuppression including febrile neutropenia and sepsis; blood counts before each cycle.
- ALT and AST increases; liver tests before starting and periodically.
- Extravasation can cause tissue necrosis; a central venous catheter should be considered.
- Rhabdomyolysis: monitor CPK; caution with statins.
- Tumour lysis syndrome, which may be fatal, can occur; strong CYP3A inducers should be avoided.
Side effects
- Most common: nausea (37.6%), fatigue (34.3%), anaemia (33.9%), thrombocytopenia (27.7%) and neutropenia (25.2%).
- Serious adverse reactions in 34.3% of patients, most often pneumonia (3.7%) and thrombocytopenia (2.9%); fatal adverse reactions in 5%, mostly due to lung infections.
Interactions
- Itraconazole (a strong CYP3A4 inhibitor) increased exposure approximately 2.7-fold; strong or moderate CYP3A inhibitors should be avoided, otherwise the dose is halved.
- Strong CYP3A inducers (e.g. carbamazepine, phenytoin, rifampicin, St John's wort) should be avoided.
- Medicines associated with rhabdomyolysis (e.g. statins) require caution.
Pregnancy and breastfeeding
- Can cause foetal harm; women should use contraception for 7 months and men (condom) for 4 months after the last dose.
- Contraindicated during breastfeeding.
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)
- ZepzelcaPharma Mar S.A. · EMEA/H/C/006673
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Zepzelca
- Liechtenstein
- Zepzelca
- Norway
- Zepzelca
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. Zepzelca – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/zepzelca-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.