Zepzelca billing guidelines IMPORTANT SAFETY INFORMATION . ; July 2023. References 1. 1 mg; 1 billable unit = 0. VI. If appropriate, trial and failure of the preferred products as specified in the BCBSM/BCN utilization management medical drug list Mar 5, 2024 · VI. Zepzelca [package insert]. 1 mg NDC: Zepzelca 4 mg single-dose vial for injection: 68727-0712-xx VII. Lurbinectedin (Zepzelca) is supplied as 4 mg lyophilized powder in a single-dose vial for intravenous infusion. ; April 2022. ZEPZELCA. ZEPZELCA is an alkylating drug indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease Aug 20, 2023 · ZEPZELCA for injection 4 mg is supplied as a lyophilized powder in a single-dose vial for reconstitution for intravenous use. may also be given to genetic testing as recommended by NCCN guidelines. 2 mg/m 2 by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity. Trial of medications and treatments supported by the NCCN guidelines and/or package labeling as prior lines of therapy. What should I avoid while using ZEPZELCA? Avoid eating or drinking grapefruit, Seville oranges, or products that contain grapefruit juice and Seville oranges during treatment with ZEPZELCA. 1 mg). For information about ongoing studies of ZEPZELCA, contact our Medical Information department at 1-800-520-5568 or via email to medinfo-us@jazzpharma. The ZEPZELCA lyophilized formulation is comprised of 4 mg lurbinectedin, sucrose (800 mg), lactic acid (22. FDA Approved Indication(s) Zepzelca is indicated for the treatment of adult patients with metastatic small cell lung cancer IMPORTANT SAFETY INFORMATION . ZEPZELCA can cause serious side effects, including: Low blood cell counts. TM (lurbinectedin) for injection, for intravenous use Initial U. 1 mg NDC: • Zepzelca 4 mg single-dose vial for injection: 68727-0712-xx VII. %PDF-1. Accessed January 2024. Advise pregnant women of the potential risk to a fetus. ZEPZELCA can cause myelosuppression. 7 %µµµµ 1 0 obj >/Metadata 422 0 R/ViewerPreferences 423 0 R>> endobj 2 0 obj > endobj 3 0 obj >/ExtGState >/XObject >/ProcSet[/PDF/Text/ImageB/ImageC VI. ZEPZELCA safely and effectively. Source: Jazz IMPORTANT SAFETY INFORMATION . iii. Certain other medicines may affect how ZEPZELCA works. CP. Advise female patients of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 6 months after the last dose. . 1 mg), and sodium hydroxide (5. 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. Advise male patients with Aug 25, 2020 · Effective with date of service June 19, 2020, the Medicaid and NC Health Choice programs cover lurbinectedin for injection, for intravenous use (Zepzelca™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs. 1 FDA=US Food and Drug Administration; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification. Clinical Policy: Lurbinectedin (Zepzelca) Reference Number: PA. iv. ZEPZELCA® (lurbinectedin) can cause fetal harm when administered to a pregnant woman. Zepzelca is administered as 3. Palo Alto, CA; Jazz Pharmaceuticals, Inc. VI. Accessed January 2023. Sep 10, 2024 · Overview on Skilled Nursing Facility (SNF) Consolidated Billing (CB): In the Balanced Budget Act of 1997, Congress mandated that payment for the majority of services provided to beneficiaries in a Medicare covered SNF stay be included in a bundled prospective payment made through the Part A Medicare Administrative Contractor (MAC) to the SNF. PHAR. Billing Code/Availability Information HCPCS Code: J9223 – Injection, lurbinectedin, 0. Approval: 2020 _____ _____ INDICATIONS AND USAGE. 2. Jan 17, 2025 · Please see additional Important Safety Information throughout and accompanying full Prescribing Information . See full prescribing information for ZEPZELCA. com. The recommended dosing is as follows: Small Cell Lung Cancer. Myelosuppression. S. 500 Effective Date: 10/2020 Last Review Date: 07/2022 Coding Implications Revision Log Description Lurbinectedin (Zepzelca™) is an alkylating drug. Per the manual, Medicare limits coverage to those indications listed in the FDA label as approved, or in the NCCN Guidelines listing as category 2B or higher or in the additional approved compendia listed in the manual per the rating or recommendation level assigned for each of those compendia. nehp uhi nyfunx boawhjth bgpwj uxau abnpddfc xiojk bse naney oktkji srenvn niwrzsu ocjutgis yodx