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ZEPZELCA (lurbinectedin) for injection 4mg

Safety profile in the phase 2 trial

Permanent discontinuation due to an adverse reaction occurred in 1.9% of patients with metastatic small cell lung cancer (SCLC) who received ZEPZELCA™ (lurbinectedin).1

Adverse Reactions (≥10%) in Patients With SCLC1

 
 
N=105
Adverse reaction
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.

Select Laboratory Abnormalities (≥20%) Worsening From Baseline in Patients With SCLC1

 
 
N=105a
Laboratory abnormality
All Gradesb (%)
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.

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/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.

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 (≥20%), including laboratory abnormalities, are 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, and diarrhea.

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.

Please see accompanying full Prescribing Information.

Reference: 1. ZEPZELCA (lurbinectedin). Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.

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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