Lurbinectedin is an alkylating drug indicated in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, among other approved uses. MedsAcross supplies Lurbinectedin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZEPZELCA is an alkylating drug indicated: • in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.
Source: US FDA prescribing information
Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death. Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumors in mice.
Source: US FDA prescribing information
• Recommended Dosage: 3.2 mg/m 2 administered as an intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity. • Administration via a central venous line is recommended to reduce the risk of extravasation that can cause tissue necrosis requiring debridement. • To reduce the risk of febrile neutropenia, administer granulocyte colony-stimulating factor (G-CSF) [Refer to Prescribing Information]. • To reduce the risk of nausea, administer corticosteroids and serotonin agonists prior to Cycle 1 and consider use for subsequent cycles. • Moderate Hepatic Impairment: Recommended dosage is 1.6 mg/m 2 administered intravenously every 21 days until disease progression or unacceptable toxicity. • Severe Hepatic Impairment: Avoid use of ZEPZELCA.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
• Myelosuppression: Monitor blood counts prior to each administration. Initiate treatment with ZEPZELCA only if baseline neutrophil count is ≥ 1,500 cells/mm 3 and platelet count is ≥ 100,000/mm 3. For neutrophil count less than 500 cells/mm 3 or any value less than lower limit of normal, administer G-CSF. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity. • Hepatotoxicity: Monitor liver function tests prior to initiating ZEPZELCA, periodically during treatment and as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity. • Extravasation Resulting in Tissue Necrosis: Consider use of a central venous catheter to reduce the risk of extravasation. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA infusion.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression • Hepatotoxicity • Extravasation Resulting in Tissue Necrosis • Rhabdomyolysis The most common adverse reactions, for ZEPZELCA in combination with atezolizumab including laboratory abnormalities, (≥ 15%) are: decreased lymphocytes, decreased platelets, decreased hemoglobin, decreased neutrophils, nausea, fatigue, increased alkaline phosphatase, decreased sodium, increased ALT, increased AST, decreased calcium, increased creatinine, musculoskeletal pain, decreased appetite and diarrhea.
Source: US FDA prescribing information
Effect of Other Drugs on ZEPZELCA: Avoid coadministration with strong or a moderate CYP3A inhibitors and strong CYP3A inducers. Effect of Other Drugs on ZEPZELCA Strong and Moderate CYP3A Inhibitors Coadministration of ZEPZELCA with a strong or a moderate CYP3A inhibitor increases lurbinectedin systemic exposure, which may increase the incidence and severity of adverse reactions to ZEPZELCA. Avoid grapefruit and Seville oranges during ZEPZELCA treatment, as these contain strong or moderate inhibitors of CYP3A. Avoid coadministration of ZEPZELCA with strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the dose of ZEPZELCA. Strong CYP3A Inducers Avoid coadministration of ZEPZELCA with strong CYP3A inducers. Coadministration of ZEPZELCA with a strong CYP3A inducer may decrease lurbinectedin systemic exposure, which may decrease the efficacy of ZEPZELCA.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Lurbinectedin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zepzelca 0.5 mg/mL powder for injectionIntravenous Cold chain | Jazz Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Lurbinectedin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lurbinectedin, including Zepzelca.
Yes. The US FDA first approved Lurbinectedin on 15 June 2020, according to Drugs@FDA.
Yes. Lurbinectedin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Lurbinectedin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Lurbinectedin is classified under ATC code L01XX69 (Lurbinectedin).
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