Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
LURBINECTEDIN (UNII: 2CN60TN6ZS) (LURBINECTEDIN - UNII:2CN60TN6ZS)
Jazz Pharmaceuticals, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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 [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). None. Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.1)] , ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no available data to inform the risk of ZEPZELCA use in pregnant women. Intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m2 clinical dose) to pregnant rats during the period of organogenesis caused embryolethality (see Data) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and mi
How Supplied ZEPZELCA (lurbinectedin) for injection is supplied as a sterile, preservative-free, white to off‑white lyophilized powder in a single-dose clear glass vial. Each carton (NDC 68727‑712-01) contains 4 mg in one single-dose vial. Storage and Handling Store refrigerated at 2° to 8°C (36° to 46°F). ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures1 .
New Drug Application
Jazz Pharmaceuticals, Inc. ---------- Patient Information PATIENT INFORMATION ZEPZELCA® [zep zel' kah] (lurbinectedin) for injection What is ZEPZELCA? ZEPZELCA is used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC). ZEPZELCA may be used when your lung cancer: o has spread to other parts of the body (metastatic), and o you have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. It is not known if ZEPZELCA is safe and effective in children. Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems. • are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby. Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA. o You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA. o Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA. Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA. • are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How will I receive ZEPZELCA? • ZEPZELCA is given by an intravenous (IV) infusion i Прочитайте повний документ
ZEPZELCA- LURBINECTEDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION JAZZ PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZEPZELCA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZEPZELCA. ZEPZELCA (LURBINECTEDIN) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2020 RECENT MAJOR CHANGES Dosage and Administration (2.3) 07/2023 INDICATIONS AND USAGE ZEPZELCA is an alkylating drug indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. (1) 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). (1) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS For injection: 4 mg lyophilized powder in a single-dose vial. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • • • 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. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JAZZ PHARMACEUTICALS, INC. AT 1-800- 520-5568 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • USE IN SPECIFIC POPULATIONS ® Recommended dosage: 3.2 mg/m every 21 days. (2.1) 2 Administer ZEPZELCA as an intravenous infusion over 60 minutes. (2.1) Consider premedication with corticosteroids and serotonin antagonists. (2.3) Myelosuppression: Monitor blood counts prior to each administration. Initiate trea Прочитайте повний документ