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Answers to frequently asked questions about ZEPZELCATM (lurbinectedin)

Questions about Dosing & Administration

What is the dosage of ZEPZELCA?

The recommended dose of ZEPZELCA is 3.2 mg/m2 by intravenous infusion over 60 minutes, repeated every 21 days until disease progression or unacceptable toxicity.1

Initiate treatment with ZEPZELCA only if absolute neutrophil count (ANC) is ≥1,500 cells/mm3 and platelet count is ≥100,000/mm3.1

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How do I administer ZEPZELCA?

ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures.1
Follow these steps for the preparation and administration of ZEPZELCA1

  • Inject 8 mL of Sterile Water for Injection USP into the vial, yielding a solution containing 0.5 mg/mL of ZEPZELCA. 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 (mL) =
    Body Surface Area (m2) x Individual Dose (mg/m2)
    0.5 mg/mL
  • 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

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How do I prepare my patients for ZEPZELCA?

Consider administering the following pre-infusion medications for antiemetic prophylaxis before treatment with ZEPZELCA1

  • Corticosteroids (dexamethasone 8 mg intravenously or equivalent)
  • Serotonin antagonists (ondansetron 8 mg intravenously or equivalent)

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General questions about ZEPZELCA

Who makes ZEPZELCA?

ZEPZELCA is distributed by Jazz Pharmaceuticals, Inc., under license from PharmaMar, S.A.1

Learn more about Jazz Pharmaceuticals >>

When was ZEPZELCA approved by the FDA?

The FDA granted accelerated approval to ZEPZELCA™ (lurbinectedin) on June 15, 2020.2

ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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What is the mechanism of action (MOA) of ZEPZELCA?

ZEPZELCA is an alkylating agent that binds to guanine residues in the minor groove of DNA,
forming adducts and resulting in a bending of the DNA helix towards the major groove.1

Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.1

ZEPZELCA was also shown to inhibit human monocyte activity in vitro and to reduce macrophage infiltration in implanted tumors in mice.1

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What clinical trials for ZEPZELCA are in progress?

For information about ongoing studies of ZEPZELCA, contact our Medical Information department at 1-800-520-5568 or via email to jazzpharma@medcomsol.com.

See the study design for the phase 2 study of ZEPZELCA >>

What are the drug interactions for ZEPZELCA?

Strong and moderate CYP3A inhibitors: coadministration with a strong or a moderate CYP3A inhibitor increases lurbinectedin systemic exposure, which may increase the incidence and severity of adverse reactions to ZEPZELCA. Avoid coadministration of ZEPZELCA with strong or moderate CYP3A inhibitors. If the coadministration of ZEPZELCA with a moderate CYP3A inhibitor cannot be avoided, consider dose reduction of ZEPZELCA, if clinically indicated.1

Strong and moderate CYP3A inducers: coadministration with a strong CYP3A inducer decreases lurbinectedin systemic exposure, which may reduce ZEPZELCA efficacy. Avoid coadministration of ZEPZELCA with strong or moderate CYP3A inducers.1

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How do I order ZEPZELCA for my patient(s)?

ZEPZELCA is available for purchase from the authorized Specialty Distributors and group purchasing organizations.

Get details and contact information on our Ordering Information page >>

Questions about the study design

How was the pivotal study of ZEPZELCA designed?

The phase 2 study was a multicenter, open-label, multi-cohort trial evaluating ZEPZELCA as a single agent in 105 adult patients with advanced or metastatic SCLC with disease progression on or after platinum-based chemotherapy. Patients received ZEPZELCA 3.2 mg/m2 by intravenous infusion every 21 days (one cycle) for a median of 4 cycles (range: 1 to 24 cycles). The median age was 60 years (range: 40 to 83 years). Baseline ECOG performance status was 0–1 in 92% of patients. The major efficacy outcome measure was confirmed investigator-assessed ORR. Additional efficacy outcome measures included duration of response, and an Independent Review Committee assessed ORR using Response Evaluation Criteria in Solid Tumors v1.1.1,3

ECOG=Eastern Cooperative Oncology Group; ORR=overall response rate.

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Questions about patient support

Is there a patient support program for ZEPZELCA?

Yes. The JazzCares Program is committed to helping patients get access to Jazz medications and the support they need.

Learn more about access and support at JazzCares.com >>

Is there patient support material for ZEPZELCA?

Yes. The Patient Brochure for ZEPZELCA can help patients and caregivers better understand treatment with ZEPZELCA, including dosing and administration, side effects, and support and access.

Download the Patient Brochure

INDICATION

ZEPZELCA™ (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Myelosuppression
ZEPZELCA can cause myelosuppression. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients.

Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days. Grade 3 or 4 anemia occurred in 17% of patients.

Administer ZEPZELCA only to patients with baseline neutrophil count of at least 1,500 cells/mm3 and platelet count of at least 100,000/mm3.

Monitor blood counts including neutrophil count and platelet count prior to each administration. For neutrophil count less than 500 cells/mm3 or any value less than lower limit of normal, the use of G-CSF is recommended. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

Hepatotoxicity
ZEPZELCA can cause hepatotoxicity. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA, Grade 3 elevations of ALT and AST were observed in 6% and 3% of patients, respectively, and Grade 4 elevations of ALT and AST were observed in 0.4% and 0.5% of patients, respectively. The median time to onset of Grade ≥3 elevation in transaminases was 8 days (range: 3 to 49), with a median duration of 7 days.

Monitor liver function tests, prior to initiating ZEPZELCA, periodically during treatment, and as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

Embryo-Fetal Toxicity
ZEPZELCA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 4 months after the final dose.

Lactation
There are no data on the presence of ZEPZELCA in human milk, however, because of the potential for serious adverse reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with ZEPZELCA and for 2 weeks after the final dose.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions, including laboratory abnormalities, (≥20%) are leukopenia (79%), lymphopenia (79%), fatigue (77%), anemia (74%), neutropenia (71%), increased creatinine (69%), increased alanine aminotransferase (66%), increased glucose (52%), thrombocytopenia (37%), nausea (37%), decreased appetite (33%), musculoskeletal pain (33%), decreased albumin (32%), constipation (31%), dyspnea (31%), decreased sodium (31%), increased aspartate aminotransferase (26%), vomiting (22%), decreased magnesium (22%), cough (20%), and diarrhea (20%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors

Avoid coadministration with a strong or a moderate CYP3A inhibitor as this increases lurbinectedin systemic exposure which may increase the incidence and severity of adverse reactions to ZEPZELCA. If coadministration of ZEPZELCA with a moderate CYP3A inhibitor cannot be avoided, consider dose reduction of ZEPZELCA, if clinically indicated.

Strong and Moderate CYP3A Inducers

Avoid coadministration with a strong or moderate CYP3A inducer. Coadministration with a strong CYP3A inducer decreases lurbinectedin systemic exposure which may reduce ZEPZELCA efficacy.

GERIATRIC USE

Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients.

There was a higher incidence of serious adverse reactions in patients ≥65 years of age than in patients <65 years of age (49% vs 26%, respectively). The serious adverse reactions most frequently reported in patients ≥65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%).

Please see accompanying full Prescribing Information.

References: 1. ZEPZELCA (lurbinectedin). Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2. US Food and Drug Administration: Oncology Center of Excellence. FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer. Accessed October 26, 2020. 3. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654.

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Important safety Information

Myelosuppression
ZEPZELCA can cause myelosuppression. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients.

Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days. Grade 3 or 4 anemia occurred in 17% of patients.