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Zepzelca Dosage

Generic name: LURBINECTEDIN .5mg in 1mL
Dosage form: injection, powder, lyophilized, for solution

Medically reviewed by Drugs.com. Last updated on Jun 15, 2020.

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.

Table 1: Dose Reduction for ZEPZELCA for Adverse Reactions

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.

Table 2: Dosage Modifications for ZEPZELCA for Adverse Reactions

Adverse Reaction

Severitya

Dosage Modification

Neutropeniab

[see Warnings and Precautions (5.1)]

Grade 4

or

Any grade febrile neutropenia

Withhold ZEPZELCA until Grade ≤ 1
Resume ZEPZELCA at a reduced dose

Thrombocytopenia

[see Warnings and Precautions (5.1)]

Grade 3 with bleeding

or

Grade 4

Withhold ZEPZELCA until platelet ≥ 100,000/mm3
Resume ZEPZELCA at reduced dose

Hepatotoxicity

[see Warnings and Precautions (5.2)] and other adverse reactions

Grade 2

Withhold ZEPZELCA until Grade ≤ 1
Resume ZEPZELCA at same dose

Grade ≥ 3

Withhold ZEPZELCA until Grade ≤ 1
Resume ZEPZELCA at reduced dose
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.

Premedication

Consider administering the following pre-infusion medications for antiemetic prophylaxis [see Adverse Reactions (6.1)]:

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 and Administration

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:
volume calculation
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).
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.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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