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Zepzelca

lurbinectedin
RNA Pol II Inhibitor FDA Approved 2020 Jazz
Route
IV
Half-Life
~48 hrs
FDA Approved
2020
Manufacturer
Jazz
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1. Indications and Usage

Metastatic SCLC after platinum.

2. Dosage and Administration

3.2 mg/m2 IV Q3W.

3. Dosage Forms and Strengths

4 mg powder/vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Myelosuppression: Monitor CBCs.
  • Hepatotoxicity: Monitor LFTs.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (43%), Neutropenia (43%), Nausea (37%), Decreased Appetite (26%), MSK Pain (22%), Anemia (18%)

Fatigue
43%
Neutropenia
43%
Nausea
37%
Decreased Appetite
26%
MSK Pain
22%
Anemia
18%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Avoid strong CYP3A modulators.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

DNA minor groove binder inhibiting RNA Pol II.

Pharmacokinetics

Vd: 5770 L. t1/2: 51h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Zepzelca Trials on ClinicalTrials.gov ↗ 📚 PubMed: Zepzelca Clinical Trials ↗
FDA-Approved Tumor Types

Zepzelca has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

SCLC
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Zepzelca. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Zepzelca (lurbinectedin) approved for?

Zepzelca (lurbinectedin) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Zepzelca (lurbinectedin) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Zepzelca (lurbinectedin) work?

DNA minor groove binder inhibiting RNA Pol II.

What are the most common side effects?

Fatigue (43%), Neutropenia (43%), Nausea (37%), Decreased Appetite (26%), MSK Pain (22%), Anemia (18%) Fatigue 43% Neutropenia 43% Nausea 37% Decreased Appetite 26% MSK Pain 22% Anemia 18%

← All Therapies Full Prescribing Information ↗