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| Dear {{customText[ Dr | Mr | Mrs | Ms | Miss | ]}}{{customText[##accFname## ##accLname##|##accLname##|##accFname##]}}, |
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| I would like to share a published article in Lung Cancer that may be of interest to you as you think about how to treat your patients with small cell lung cancer (SCLC). The data in this article describe efficacy and safety of lurbinectedin in patients who relapsed ≥180 days after their last dose of first-line platinum-based chemotherapy. |
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| Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment |
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| Subbiah V, Paz-Ares L, Besse B, et al. Lung Cancer. 2020;150:90-96. doi:10.1016/j.lungcan.2020.10.003 |
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| Free online access |
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| Free online access |
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| Disclaimer |
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| This journal reprint article is bring provided as a professional courtesy by Jazz Pharmaceuticals, Inc. This scientific publication contains information that may or may not be contained within the accompanying package insert. Providing this reprint should not be construed as a recommendation for use of any Jazz Pharmaceuticals product for nonapproved uses. Prior to prescribing, please refer to the accompanying Prescribing Information, which includes the approved Indication and a discussion of the benefits and risks associated with our product. |
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| The opinions expressed in this reprint do not necessarily reflect those of Jazz Pharmaceuticals. Readers are encouraged to contact the primary authors with questions regarding the content of the reprint. Jazz Pharmaceuticals does not assume responsibility for any injury and/or damage to persons or property out of or related to any use of the information contained in this reprint. |
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| Financial Disclosure Statement |
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| Detailed information on funding amounts received by the authors of this publication is available at http://www.cms.gov/openpayments. |
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| INDICATION |
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| 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. |
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| 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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| IMPORTANT SAFETY INFORMATION |
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| Myelosuppression |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Hepatotoxicity |
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| 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. |
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| 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. |
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| Extravasation Resulting in Tissue Necrosis |
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| Extravasation of ZEPZELCA resulting in skin and soft tissue injury, including necrosis requiring debridement, can occur. Consider use of a central venous catheter to reduce the risk of extravasation, particularly in patients with limited venous access. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA infusion. |
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| If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis. The time to onset of necrosis after extravasation may vary. |
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| Administer supportive care and consult with an appropriate medical specialist as needed for signs and symptoms of extravasation. Administer subsequent infusions at a site that was not affected by extravasation. |
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| Rhabdomyolysis |
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| Rhabdomyolysis has been reported in patients treated with ZEPZELCA. |
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| Monitor creatine phosphokinase (CPK) prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold or reduce the dose based on severity. |
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| Embryo-Fetal Toxicity |
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| 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. |
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| Lactation |
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| 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. |
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| MOST COMMON ADVERSE REACTIONS |
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| 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%). |
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| DRUG INTERACTIONS |
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| Strong and Moderate CYP3A Inhibitors |
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| 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. |
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| Strong and Moderate CYP3A Inducers |
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| Avoid coadministration with a strong or moderate CYP3A inducer. Coadministration with a strong CYP3A inducer decreases lurbinectedin systemic exposure which may reduce ZEPZELCA efficacy. |
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| GERIATRIC USE |
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| 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. |
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| 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%). |
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| Please see accompanying full Prescribing Information. |
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| Sincerely, |
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| Jazz Pharmaceuticals, Inc. |
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| 3170 Porter Drive |
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| Palo Alto, CA 94304 |
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| ZEPZELCA is a registered trademark of PharmaMar, S.A. used by Jazz Pharmaceuticals under license. |
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| ©2022 Jazz Pharmaceuticals US-LUR-2200152 Rev0422 |
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