Dosing and Administration Imfinzi Package Insert Guideline Imfinzi is considered medically necessary for members ≥ 18 years of age, for use as a single agent, when prescribed by an oncologist for the following indications: The medicines below all contain the following active ingredient(s): durvalumab. AstraZeneca has filed for a US licence for its Imfinzi immunotherapy in early-stage lung cancer, while announcing promising results from a lung cancer combination involving a … (New disease entity) Small cell lung cancer The FIRST and ONLY immunotherapy approved in the first-line maintenance setting for patients with locally advanced or metastatic urothelial carcinoma. MICROMEDEX Healthcare Series. Not all products listed in the package insert may be available in all geographies. • Imfinzi 120 mg/2.4 mL single-dose vial: 00310-4500-xx • Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx VII. Keep vial in original carton to protect from light. 10/2020 . You can select a medicine from this list to find out more - including side effects, age restrictions, food interactions and whether the medicine is subsidised by the government on the pharmaceutical benefits scheme (PBS). Dose modifications for Vectibix concerning dermatologic toxicity are provided [see Dosage and Administration (2.3)]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2020. Do not freeze or shake. with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS)≥10] as determined by an FDA approved test.2(1.19, 2.1) Adult Indications: Additional Dosing Regimen of 400mg Every Discard unused portion. Imfinzi™ is a programmed death ligand-1 (PD-L1) blocking antibody administered intravenously as immunotherapy. 2. Imfinzi [package insert]. BAVENCIO ® (avelumab) is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. FULL PRESCRIBING INFORMATION . LIBTAYO is approved for people with a type of lung cancer called non–small cell lung cancer (NSCLC). Find a Trial. IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. IMFINZI ® (durvalumab) is administered as a 60-minute IV infusion with no premedication required. Retrieved January 7, 2020 from Lexi-Comp Online with AHFS. Page 6of 56 The recommended dose of IMFINZI depends on the indication. and effectively. These highlights do not include all the information needed to use LYNPARZA safely . I. Imfinzi Package Insert Guideline Imfinzi is considered medically necessary for members ≥ 18 years of age, for use as a single agent, when prescribed by an oncologist for the following indications: A. Urothelial Carcinoma (MCC); either:* a. ©2020, Magellan Rx Management VII. The clinical reviewer, Megan May, PharmD, BCOP has no actual or potential conflict of Accessed July 2020. Microscope slides, positively charged 3. Rx only. Imfinzi™ (durvalumab) Injection. Imfinzi [package insert]. 2/16/2018: FDA approved for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Urothelial Carcinoma The recommended dose of IMFINZI (durvalumab) is 10 mg/kg every 2 weeks as long as clinical 1. A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine, some non-prescription medicines and some biologicals. The following reagents and materials may be required for staining but are not provided: 1. Accessed November 2020. Recommended Dosage in Unresectable Stage III NSCLC Q2W weight-based or Q4W fixed dosing with IMFINZI ® (durvalumab) 1. HIGHLIGHTS OF PRESCRIBING INFORMATION. 2. for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications [see Boxed Warning and Adverse Reactions (6.1, 6.3)]. Wilmington, DE: AstraZeneca Pharmaceuticals LP ; June 2020. Store at 2° to 8°C (36° to 46°F). IMFINZI® Product Monograph.COPYRIGHT2017-2020, ASTRAZENECA CANADA INC. Restricted Access – Do not disseminate or copy without approval. Massard C, Gordon MS, Sharma S, et al. VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), urothelial carcinoma (UC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument. INDICATIONS . Accessed March 16, 2020. The decision to withdrawal Imfinzi’s indication in the bladder cancer space was made in conjunction with the Food and ... Imfinzi [package insert]. Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand1 Immune - Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. 3 IMFINZI CPCNP localmente avançado 10mg/kg acada2semanasou 1500mg a cada4semanasa Atéprogressão da doença ou toxicidade inaceitável,ou um máximo de 12mesesb CPPC-DE 1500mgc em associação com quimioterapiad,e a cada 3semanas(21dias) durante See full safety for more information. Massard C, Gordon MS, Sharma S, et al. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL. Dr. Holle and Ms. Moran have disclosed that they have no actual or potential conflict of interest in relation to this program. 2. Share your location or enter your city or zip code to find studies near you. Xylene (Histological grade) 5. Imfinzi is available in … CRYSVITA (burosumab-twza) is the only FDA-approved treatment for X-linked hypophosphatemia (XLH), a disease that can lead bones to “soften” and weaken over time. List of all Prescribing information links configured in PI Central; Brand Prescribing Information URL Medication Guide URL Instructions for Use IFU URL References 1. Durvalumab. Wilmington, DE; AstraZeneca Pharmaceuticals LP; August 2019. (2019, October). … Patients with a body weight 30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks See full prescribing information for LYNPARZA. 120 mg/2.4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. Recommended control tissue 2. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of … IMFINZI (durvalumab) POLICY . Lexi-Comp Online. 5/2020 . Consult your local support representative. IMFINZI is the cornerstone in an extensive Immuno-Oncology program across multiple cancer types and stages of disease AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZI™ (durvalumab). References 1. 2.0 Dose must be rounded down to the nearest vial size if calculated dose is within 10% of the nearest vial size. Search for Clinical Trials by condition, keyword or trial number. The indications below including FDA-approved indications and compendial uses are considered a covered ... Imfinzi [package insert]. Durvalumab (Imfinzi) package insert; History of changes in FDA indication Non-small cell lung cancer. 1 INDICATIONS AND USAGE 1.1 Metastatic Merkel Cell Carcinoma BAVENCIO (avelumab) is indicated for … See full prescribing information for POMALYST. IMFINZI: - Discard product if it contains particulate matter, is cloudy, or discolored - Discard unused portion. Disease must have progressed during or following platinum-containing chemotherapy b. AHFS DI. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use POMALYST safely and effectively. beginning of content Active ingredient: durvalumab. Learn more about TECENTRIQ (atezolizumab), efficacy, safety, and patient eligibility for extensive-stage small cell lung cancer. IMFINZI is administered as an intravenous infusion over 60 minutes. NDC 0310-4500-12. Imfinzi [package insert]. 5/2020 - Do not freeze - Protect from light - See package insert for detailed storage information - Store between 36 to 46 degrees F - Store in original container Dosage and Administration (2.8) Warnings and Pre cautions (5.2) Warnings and Precautions (5.3, 5.9) 5/2020 12/2020 : 10/2020 . frequently than listed in the package insert, or generally accepted by peers and the reason for additional services is not justified by submitted documentation. Wilmington, DE; AstraZeneca Pharmaceuticals LP ; November 2020. Initial U.S. Approval: 2017. Wilmington, DE; AstraZeneca Pharmaceuticals LP; June 2020. Mechanism of Action: Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory … Do not store for later use. Accessed November 2020. Page 2 of 28 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Cutaneous Squamous Cell Carcinoma LIBTAYO is indicated for the treatment of … Page 2 of 35 . Bar code labels 4. Drug UPDATES: IMFINZI™ (durvalumab) injection [Drug information / PDF] REVIEW PACKAGE INSERT FOR POSSIBLE UPDATESPACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link) BOXED WARNING: . The VENTANA PD-L1 (SP263) assay is an FDA-approved complementary diagnostic IHC test PD-L1 status in patients with locally advanced or metastatic urothelial carcinoma (mUC) who are being considered for treatment with IMFINZI™ (durvalumab). 2. Imfinzi [package insert].