YOU’RE INVITED TO AN EXPERT-LED VIRTUAL PROGRAM
SPONSORED BY JAZZ PHARMACEUTICALS
FOR THE
Second-line Treatment ZEPZELCATM of Metastatic Small Cell
(lurbinectedin) Lung Cancer (SCLC)
EXPLORE
THIS PROGRAM WILL COVER:
• Disease burden and treatment-related challenges in the management of SCLC
• An overview of ZEPZELCA, including recommendations from the NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines®) for SCLC
• Clinical efficacy and safety of ZEPZELCA demonstrated in the phase 2 clinical trial that included patients across the platinum-resistant and platinum-sensitive spectrum of SCLC
EVENT DETAILS:
Tuesday, September 14, 2021 3:00 pm - 3:45 pm ET
at ONS Bridge 2021
FEATURING FACULTY PRESENTER:
Jill Avery, DNP, APN-BC, ACNP, OCN
Advanced Practice Nurse
Department of Hematology/Oncology
Central Arkansas Veterans Healthcare System Little Rock, Arkansas
INDICATION
ZEPZELCA (lurbinectedin) for injection 4 mg, 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.
Please see additional Important Safety Information on the following page and accompanying full Prescribing Information.
IMPORTANT SAFETY INFORMATION (continued)
Myelosuppression (continued)
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.
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, 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.
Please see accompanying full Prescribing Information.
For US healthcare providers only. Please note that there are no certified continuing medical education credits approved for this program. Jazz Pharmaceuticals is committed to the principles of the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals. As such, spouses or guests are not permitted to attend the program or events, and their associated expenses will not be covered or reimbursed. Due to state regulations, physicians and healthcare professionals licensed in Minnesota and Vermont are not able to receive a meal with the program. We appreciate your cooperation in this regard. Please note that meals may be reportable based on various state and federal laws.
ZEPZELCA is a trademark of PharmaMar, S.A. used by Jazz Pharmaceuticals under license. ©2021 Jazz Pharmaceuticals US-LUR-2000202 REV0121