Lurbinectedin

ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

). 3 Reconstitution Parenteral Products: • ZEPZELCA is a cytotoxic drug. Follow applicable special handling and disposal procedures. • Prepare the solution for infusion using aseptic technique as follows: • Inject 8 mL of Sterile Water for Injection USP into the vial.

Shake the vial until complete dissolution. The reconstituted solution is a clear, colourless or slightly yellowish solution, essentially free of visible particles. ZEPZELCA (lurbinectedin) Page 9 of 35 • Visually inspect the solution for particulate matter and discoloration.

If particulate matter or discoloration is observed, do not administer. 9% Sodium Chloride Injection USP or 5% Dextrose Injection USP. 5 mg/mL Table 3. 4 Administration Consider use of a central venous catheter to reduce the risk of extravasation with ZEPZELCA.

9% Sodium Chloride Injection USP or 5% Dextrose Injection USP). 9% Sodium Chloride Injection USP or 5% Dextrose Injection USP). 22 micron are recommended. 9% Sodium Chloride Injection USP. Compatibility with other IV administration materials and the diluted ZEPZELCA solution has been demonstrated in the following materials: • Polyolefin containers (polyethylene, polypropylene and mixtures).