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ZEPZELCA (lurbinectedin) Logo

For adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy,

ZEPZELCATM (lurbinectedin) DEMONSTRATED A SAFETY
PROFILE WITH A LOW DISCONTINUATION RATE DUE TO ADVERSE REACTIONS

Permanent discontinuation due to an adverse reaction occurred in 1.9% of patients with
SCLC (2 of 105)1

  • Adverse reactions resulting in permanent discontinuation in ≥1% of patients included peripheral
    neuropathy and myelosuppression

Dosage interruptions due to an adverse reaction occurred in 30.5% of patients1

  • Adverse reactions requiring dosage interruption in ≥3% of patients included neutropenia and
    hypoalbuminemia

Dosage reductions due to an adverse reaction occurred in 25% of patients1

  • Adverse reactions requiring dosage reductions in ≥3% of patients included neutropenia, febrile
    neutropenia, and fatigue
Adverse Reactions (≥10%) in Patients With SCLC1
Adverse reaction ZEPZELCA (N=105)
All Gradesa,b (%) Grades 3–4 (%)
General disorders
Fatigue 77 12
Pyrexia 13 0
Chest pain 10 0
Gastrointestinal disorders
Nausea 37 0
Constipation 31 0
Vomiting 22 0
Diarrhea 20 4
Abdominal painc 11 1
Musculoskeletal and connective
tissue disorders
Musculoskeletal paind 33 4
Metabolism and nutrition disorders
Decreased appetite 33 1
Respiratory, thoracic, and
mediastinal disorders
Dyspnea 31 6
Coughe 20 0
Infections and infestations
Respiratory tract infectionf 18 5
Pneumoniag 10 7
Nervous system disorders
Peripheral neuropathyh 11 1
Headache 10 1


aGraded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 4.0.

bNo grade 5 adverse reactions were reported.

cIncludes abdominal pain, abdominal pain upper, and abdominal discomfort.

dIncludes musculoskeletal pain, back pain, arthralgia, pain in extremity, musculoskeletal chest pain, neck pain, bone pain, and myalgia.

eIncludes cough and productive cough.

fIncludes upper respiratory tract infection, viral upper respiratory tract infection, respiratory tract infection, and bronchitis.

gIncludes pneumonia and lung infection.

hIncludes neuropathy peripheral, neuralgia, paresthesia, peripheral sensory neuropathy, hypoesthesia, and hyperesthesia.

  • Alopecia occurred in 1% of patients2

Most adverse reactions were Grade 1 or 21,2

Select Laboratory Abnormalities (≥20%) Worsening From Baseline1
Laboratory abnormalities ZEPZELCA (N=105)
All Gradesa,b (%) Grades 3–4 (%)
Hematology
Decreased leukocytes 79 29
Decreased lymphocytes 79 43
Decreased hemoglobin 74 10
Decreased neutrophils 71 46
Decreased platelets 37 7
Chemistry
Increased creatinine 69 0
Increased alanine aminotransferase 66 4
Increased glucose 52 5
Decreased albumin 32 1
Decreased sodium 31 7
Increased aspartate aminotransferase 26 2
Decreased magnesium 22 0


aThe denominator used to calculate the rate varied from 95 to 105 based on the number of patients with a baseline value
and at least one post-treatment value.

bGraded per NCI CTCAE 4.0.

  • In the phase 2 study, 22% of patients received granulocyte colony-stimulating factor (G-CSF) for secondary prophylaxis or therapy for neutropenia, but primary prophylaxis was not allowed1,3

Get answers to some of the most frequently asked questions about ZEPZELCA

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. Data on file. LUR-2020-003. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 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.