ZEPZELCA

Following the approved recommended dosage, geometric mean (%CV) of plasma C max and AUC 0-inf , were 107 µg/L (79%) and 551 µg

• h/L (94%), respectively. No accumulation of lurbinectedin in plasma is observed upon administrations every 3 weeks.

DistributionThe volume of distribution of lurbinectedin at steady state is 504 L (39%). Plasma protein binding is approximately 99%, to both albumin and α-1-acid glycoprotein.

EliminationThe terminal half-life of lurbinectedin is 51 hours. Total plasma cl...

14.1 Extensive-Stage Small Cell Lung Cancer The efficacy of ZEPZELCA in combination with intravenous (IV) atezolizumab was evaluated in IMforte (NCT05091567), a randomized, multicenter, open-label study in patients with first-line extensive-stage small cell lung cancer (ES-SCLC). Patients were eligible if their disease had not progressed after completion of four cycles of atezolizumab, carboplatin and etoposide (induction treatment) and their Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1. The trial excluded patients with CNS metastases, history of autoimmune disease, ...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Myelosuppression [see Warnings and Precautions (5.1) ]
• Hepatotoxicity [see Warnings and Precautions (5.2) ]
• Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.3) ]
• Rhabdomyolysis [see Warnings and Precautions (5.4) ] The most common adverse reactions for ZEPZELCA as a single agent, including laboratory abnormalities, (≥20%) are leukopenia, lymphopenia, fatigue, anemia,...

None. None. ( 4 )

• 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. ( 5.1 )
• Hepatotoxicity : Monitor liver function tests prior to initiating ZEPZELCA, periodically during tr...

7 DRUG INTERACTIONS

Effect of Other Drugs on ZEPZELCA Avoid coadministration with strong or a moderate CYP3A inhibitors and strong CYP3A inducers. ( 7.1 ) 7.1 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 [see Clinical Pharmacology (12.3) ], which may increa...