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Zepzelca Generic Name & Formulations
Legal Class
Rx
General Description
Lurbinectedin 4mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Alkylating agent.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Zepzelca Indications
Indications
Metastatic small cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy.
Zepzelca Dosage and Administration
Adult
Consider premedication with corticosteroids, serontonin antagonists. Initiate only if ANC is ≥1500cells/mm3 and platelet count is ≥100000/mm3. Give by IV infusion over 60mins. 3.2mg/m2 every 21 days until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Zepzelca Contraindications
Not Applicable
Zepzelca Boxed Warnings
Not Applicable
Zepzelca Warnings/Precautions
Warnings/Precautions
Risk of myelosuppression, hepatotoxicity, rhabdomyolysis. Monitor blood counts with neutrophils, platelets prior to initiation. If neutrophils <500cells/mm3 or any value less than LLN: give G-CSF. Monitor LFTs, creatinine phosphokinase prior to and during therapy as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity. Extravasation resulting in tissue necrosis; monitor during infusion. Discontinue immediately if extravasation occurs. Moderate or severe hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Zepzelca Pharmacokinetics
See Literature
Zepzelca Interactions
Interactions
Potentiated by strong or moderate CYP3A inhibitors; avoid concomitant use. If concomitant moderate CYP3A inhibitors unavoidable; consider Zepzelca dose reduction. Antagonized by strong CYP3A inducers; avoid concomitant strong or moderate CYP3A inducers.
Zepzelca Adverse Reactions
Adverse Reactions
Leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium, diarrhea.
Zepzelca Clinical Trials
See Literature
Zepzelca Note
Not Applicable
Zepzelca Patient Counseling
See Literature
