Zepzelca Dosage
Generic name: LURBINECTEDIN .5mg in 1mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Alkylating agents
Medically reviewed by Drugs.com. Last updated on Jul 28, 2023.
Recommended Dosage
The recommended dosage of ZEPZELCA is 3.2 mg/m2 by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity.
Initiate treatment with ZEPZELCA only if absolute neutrophil count (ANC) is at least 1,500 cells/mm3 and platelet count is at least 100,000/mm3.
Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are listed in Table 1. Permanently discontinue ZEPZELCA in patients who are unable to tolerate 2 mg/m2 or require a dose delay greater than two weeks.
Dose Reduction |
Total Dose |
First Second |
2.6 mg/m2 every 21 days 2 mg/m2 every 21 days |
Dosage modifications for ZEPZELCA for adverse reactions are presented in Table 2.
Adverse Reaction |
Severitya |
Dosage Modification |
Neutropeniab |
Grade 4 or Any grade febrile neutropenia |
|
Thrombocytopenia |
Grade 3 with bleeding or Grade 4 |
|
Hepatotoxicity |
Grade 2 |
|
Grade ≥ 3 |
|
|
Rhabdomyolysis |
Grade 2 |
|
Grade ≥ 3 |
|
|
Other Adverse Reactions |
Grade 2 |
|
Grade ≥ 3 |
|
- a
- National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
- b
- Patients with isolated Grade 4 neutropenia (neutrophil count less than 500 cells/mm3) may receive G-CSF prophylaxis rather than undergo lurbinectedin dose reduction.
2.3 Dosage Modifications for Use with Strong CYP3A Inhibitors
Avoid coadministration of ZEPZELCA with strong CYP3A inhibitors. If coadministration of ZEPZELCA with a strong CYP3A inhibitor cannot be avoided, reduce the dose of ZEPZELCA by 50%. After discontinuation of a strong CYP3A inhibitor for 5 half-lives of the inhibitor, increase the ZEPZELCA dose to the dose used before starting the inhibitor.
Premedication
Consider administering the following pre-infusion medications for antiemetic prophylaxis:
- •
- Corticosteroids (dexamethasone 8 mg intravenously or equivalent)
- •
- Serotonin antagonists (ondansetron 8 mg intravenously or equivalent)
Preparation, Administration and Storage
ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures1.
Preparation
- •
- Inject 8 mL of Sterile Water for Injection USP into the vial, yielding a solution containing 0.5 mg/mL lurbinectedin. Shake the vial until complete dissolution.
- •
- Visually inspect the solution for particulate matter and discoloration. The reconstituted solution is a clear, colorless or slightly yellowish solution, essentially free of visible particles.
- •
- Calculate the required volume of reconstituted solution as follows:
- •
- For administration through a central venous line, withdraw the appropriate amount of reconstituted solution from the vial and add to an infusion container containing at least 100 mL of diluent (0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP).
- •
- For administration through a peripheral venous line, withdraw the appropriate amount of reconstituted solution from the vial and add to an infusion container containing at least 250 mL of diluent (0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP).
Administration
- •
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter is observed, do not administer.
- •
- ZEPZELCA can be administered with or without an in-line filter. If infusion lines containing in-line filters are utilized for administration of ZEPZELCA, polyethersulfone (PES) in-line filters with pore sizes of 0.22 micron are recommended.
- o
- Do not use in-line nylon membrane filters when the reconstituted ZEPZELCA solution is diluted using 0.9% Sodium Chloride Injection, USP. Adsorption of ZEPZELCA to the Nylon membrane filters has been observed when 0.9% Sodium Chloride Injection, USP is used as the diluent.
- •
- Compatibility with other intravenous administration materials and the diluted ZEPZELCA solution has been demonstrated in the following materials:
- o
- Polyolefin containers (polyethylene, polypropylene and mixtures).
- o
- Polyvinyl Chloride (PVC) (non-DEHP-containing), polyurethane and polyolefin infusion sets (polyethylene, polypropylene and polybutadiene).
- o
- Implantable venous access systems with titanium and plastic resin ports and with polyurethane or silicone intravenous catheters.
- •
- Do not co-administer ZEPZELCA and other intravenous drugs concurrently within the same intravenous line.
Storage of Infusion Solution
- •
- If not used immediately after reconstitution or dilution, the ZEPZELCA solution can be stored prior to administration for up to 24 hours following reconstitution, including infusion time, at either room temperature/ ambient light or under refrigeration at 2ºC-8ºC (36ºF-46ºF) conditions.
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