Evicore Oncology Imaging Guidelines
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LANTUS® (Insulin Glargine [Rdna Origin] Injection)
Rev. March 2007 Rx Only LANTUS® (insulin glargine [rDNA origin] injection) LANTUS® must NOT be diluted or mixed with any other insulin or solution. DESCRIPTION LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non- pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- B B Gly-30 a-L-Arg-30 b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine. Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4. CLINICAL PHARMACOLOGY Mechanism of Action: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. -
Drug Information Center Highlights of FDA Activities
Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
Radiopharmaceuticals and Contrast Media – Oxford Clinical Policy
UnitedHealthcare® Oxford Clinical Policy Radiopharmaceuticals and Contrast Media Policy Number: RADIOLOGY 034.19 T0 Effective Date: January 1, 2021 Instructions for Use Table of Contents Page Related Policies Coverage Rationale ....................................................................... 1 • Cardiology Procedures Requiring Prior Definitions .................................................................................... 10 Authorization for eviCore Healthcare Arrangement Prior Authorization Requirements .............................................. 10 • Radiation Therapy Procedures Requiring Prior Applicable Codes ........................................................................ 10 Authorization for eviCore Healthcare Arrangement Description of Services ............................................................... 13 • Radiology Procedures Requiring Prior Authorization References ................................................................................... 13 for eviCore Healthcare Arrangement Policy History/Revision Information ........................................... 14 Instructions for Use ..................................................................... 14 Coverage Rationale eviCore healthcare administers claims on behalf of Oxford Health Plans for the following services that may be billed in conjunction with radiopharmaceuticals and/or contrast media: • Radiology Services: Refer to Radiology Procedures Requiring Prior Authorization for eviCore Healthcare Arrangement for additional information. -
208054Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208054Orig1s000 MEDICAL REVIEW(S) Clinical Review Phillip B. Davis, MD Priority Review 505(b)(2) NDA Axumin (18F-Fluciclovine) CLINICAL REVIEW Application Type 505 (b) (1) Application Number(s) 208054 Priority or Standard Priority Review Submit Date(s) 9/28/2015 Received Date(s) 9/28/2015 PDUFA Goal Date 5/27/2016 Division/Office DMIP/ODEIV Reviewer Name(s) Phillip B. Davis, MD Review Completion Date 2/26/2016 Established Name 18F-Fluciclovine (Proposed) Trade Name Axumin Applicant Blue Earth Diagnostics Formulation(s) Solution Dosing Regimen 10mCi via intravenous injection Applicant Proposed PET Imaging men with suspected prostate cancer recurrence. Indication(s)/Population(s) Recommendation on Approval Regulatory Action Recommended Positron emission tomography (PET) imaging of men with Indication(s)/Population(s) suspected prostate cancer recurrence. Axumin PET imaging may (if applicable) identify sites of prostate cancer. CDER Clinical Review Template 2015 Edition 1 Version date: June 25, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 3897370 Clinical Review Phillip B. Davis, MD Priority Review 505(b)(2) NDA Axumin (18F-Fluciclovine) Table of Contents Glossary .................................................................................................................................. 8 1 Executive Summary .........................................................................................................10 1.1. Product Introduction ................................................................................................10 -
Baqsimi, INN-Glucagon
17 October 2019 EMA/CHMP/602404/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report BAQSIMI International non-proprietary name: glucagon Procedure No. EMEA/H/C/003848/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Problem statement ............................................................................................... 9 2.1.1. Disease or condition ........................................................................................... 9 2.1.2. Epidemiology .................................................................................................. 10 2.1.3. Biologic features, Aetiology and pathogenesis ..................................................... 10 2.1.4. Clinical presentation, diagnosis ......................................................................... -
Type 2 Diabetes Adult Outpatient Insulin Guidelines
Diabetes Coalition of California TYPE 2 DIABETES ADULT OUTPATIENT INSULIN GUIDELINES GENERAL RECOMMENDATIONS Start insulin if A1C and glucose levels are above goal despite optimal use of other diabetes 6,7,8 medications. (Consider insulin as initial therapy if A1C very high, such as > 10.0%) 6,7,8 Start with BASAL INSULIN for most patients 1,6 Consider the following goals ADA A1C Goals: A1C < 7.0 for most patients A1C > 7.0 (consider 7.0-7.9) for higher risk patients 1. History of severe hypoglycemia 2. Multiple co-morbid conditions 3. Long standing diabetes 4. Limited life expectancy 5. Advanced complications or 6. Difficult to control despite use of insulin ADA Glucose Goals*: Fasting and premeal glucose < 130 Peak post-meal glucose (1-2 hours after meal) < 180 Difference between premeal and post-meal glucose < 50 *for higher risk patients individualize glucose goals in order to avoid hypoglycemia BASAL INSULIN Intermediate-acting: NPH Note: NPH insulin has elevated risk of hypoglycemia so use with extra caution6,8,15,17,25,32 Long-acting: Glargine (Lantus®) Detemir (Levemir®) 6,7,8 Basal insulin is best starting insulin choice for most patients (if fasting glucose above goal). 6,7 8 Start one of the intermediate-acting or long-acting insulins listed above. Start insulin at night. When starting basal insulin: Continue secretagogues. Continue metformin. 7,8,20,29 Note: if NPH causes nocturnal hypoglycemia, consider switching NPH to long-acting insulin. 17,25,32 STARTING DOSE: Start dose: 10 units6,7,8,11,12,13,14,16,19,20,21,22,25 Consider using a lower starting dose (such as 0.1 units/kg/day32) especially if 17,19 patient is thin or has a fasting glucose only minimally above goal. -
Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach Applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer”
Departamento de Farmacia y Tecnología Farmacéutica Facultad de Farmacia y Nutrición UNIVERSIDAD DE NAVARRA “Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer” María García-Cremades Mira Pamplona, 2017 Departamento de Farmacia y Tecnología Farmacéutica Facultad de Farmacia y Nutrición UNIVERSIDAD DE NAVARRA TESIS DOCTORAL “Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer” Trabajo presentado por María García-Cremades Mira para obtener el Grado de Doctor Fdo. María García-Cremades Mira Pamplona, 2017 UNIVERSIDAD DE NAVARRA FACULTAD DE FARMACIA Y NUTRICIÓN Departamento de Farmacia y Tecnología Farmacéutica D. JOSÉ IGNACIO FERNÁNDEZ DE TROCÓNIZ FERNÁNDEZ, Doctor en Farmacia y Catedrático del Departamento de Farmacia y Tecnología Farmacéutica. Certifica: Que el presente trabajo, titulado “Pharmacokinetic/pharmacodynamic modelling-based translational approach applied to the anticancer drug gemcitabine in advanced pancreatic and ovarian cancer”, presentado por DÑA. MARÍA GARCÍA-CREMADES MIRA para optar al grado de Doctor en Farmacia, ha sido realizado bajo su dirección en los Departamentos de Farmacia y Tecnología Farmacéutica. Considerando finalizado el trabajo autorizan su presentación a fin de que pueda ser juzgado y calificado por el Tribunal correspondiente. Y para que así conste, firma la presente: Fdo.: Dr. José Ignacio F Trocóniz Pamplona, 2017 “El mundo es de los que hacen de cada momento una gran aventura” AGRADECIMIENTOS Quisiera comenzar expresando mi agradecimiento a la Universidad de Navarra y al Departamentos de Farmacia y Tecnología Farmacéutica por haberme posibilitado la realización de esta tesis doctoral. Al Dr. Iñaki Trocóniz me gustaría agradecerle la confianza y motivación que desde el primer día me ha dado. -
[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer an Exploratory Study
Journal of Nuclear Medicine, published on April 7, 2016 as doi:10.2967/jnumed.115.171389 Anti-3-[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer: An Exploratory Study Funmilayo I. Tade1, Michael A. Cohen1, Toncred M. Styblo2, Oluwaseun A. Odewole1, Anna I. Holbrook1, Mary S. Newell1, Bital Savir-Baruch3, Xiaoxian Li4, Mark M. Goodman1, Jonathon A Nye1, David M. Schuster1. Author affiliations: 1. Radiology and Imaging Sciences, Emory University, Atlanta, GA, USA 2. Surgery, Emory University, Atlanta, GA, USA 3. Radiology, Loyola University Medical Center, Maywood, Illinois, USA 4. Pathology and Laboratory Medicine, Emory University, Atlanta, GA, USA Corresponding Author: David M. Schuster, MD; Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University Hospital, 1364 Clifton Road, Atlanta, GA 30322. Telephone: 404-712-4859, Fax: 404-712-4860, email: [email protected] First Author: Funmilayo Tade, MD, MPH; Research Fellow, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University Hospital, 1364 Clifton Road, Atlanta, GA 30322. Telephone: 404-712-1348, Fax: 404-712-4860, email: [email protected] Word Count: 4,946 Grant Sponsor: Glenn Family Breast Center Grant; Winship Cancer Institute, Emory University. FLUCICLOVINE PET-CT IN BREAST CANCER The purpose of this study is to explore the uptake of the synthetic amino acid analog positron emission tomography (PET) radiotracer anti-3-[18F] FACBC (fluciclovine) in breast lesions with correlation to histologic and immunohistochemical characteristics. Methods Twelve women with breast lesions underwent 45 minute dynamic PET-CT of the thorax after intravenous administration of 366.3 ±14.8 (337.44 - 394.05) MBq of fluciclovine. -
ACMUI Chairman, Presiding
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number: (n/a) Location: Teleconference Date: Monday, March 30, 2020 Work Order No.: NRC-0868 Pages 1-262 NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION + + + + + ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES + + + + + TELECONFERENCE + + + + + MONDAY, MARCH 30, 2020 + + + + + The meeting was convened by teleconference, at 9:30 a.m., Dr. Darlene F. Metter, ACMUI Chairman, presiding. MEMBERS PRESENT: DARLENE F. METTER, M.D., Chairman A. ROBERT SCHLEIPMAN, Ph.D., Vice Chairman GARY BLOOM, Member VASKEN DILSIZIAN, M.D., Member RONALD D. ENNIS, M.D., Member RICHARD L. GREEN, Member HOSSEIN JADVAR, Member MELISSA C. MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 2 MICHAEL SHEETZ, Member MEGAN L. SHOBER, Member HARVEY B. WOLKOV, M.D., Member DESIGNATED FEDERAL OFFICERS: CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch (MSEB) LISA DIMMICK, Medical Radiation Safety Team Leader, NMSS/MSST/MSEB KELLEE JAMERSON, ACMUI Coordinator NRC STAFF PRESENT: KEVIN WILLIAMS, Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST) MARYANN AYOADE, NMSS/MSST/MSEB SAID DAIBES, Ph.D., NMSS/MSST/MSEB DANIEL DIMARCO, NMSS/MSST/MSEB JASON DRAPER, NMSS/MSST/MSEB ROBIN ELLIOTT, NMSS/MSST/MSEB JENNIFER FISHER, NMSS/MSST/MSEB SARA FORSTER, NMSS/MSST/MSEB ROBERT GALLAGHAR, R-I/DNMS/MLAB ANITA GRAY, Ph.D., NMSS/MSST/SMPB VINCENT HOLAHAN, NMSS/MSST NEAL R. -
Download Final Programme As
LETTER OF INVITATION LETTER OF INVITATION WELCOME WORDS by the EANM Congress Chair EANM’20 EANM’20 On behalf of the European Association of Nuclear Medicine, it is my great honour to invite you to the 33rd Annual EANM WORLD LEADING MEETING LEADING WORLD Congress, which will take place virtually from 22 to 30 MEETING LEADING WORLD October 2020. Nuclear Medicine keeps on growing in many number of newer features are also being planned clinical areas, from diagnostic imaging to and we will have a new format for the plenary therapy: our procedures are increasingly being sessions, new top-rated oral presentation sessions incorporated into clinical practice, in a variety of and a new ‘Top Trials’ session. settings and diseases. This success is mostly related to a peculiar characteristic of our specialty, namely A further characteristic of our Congress is its the functional approach to medicine. PET imaging multidisciplinarity, and this will be emphasised works so well because of the unique functional in 2020, with a number of sessions bringing information provided to clinicians, and this feature together physicians from many specialties as well is the key to the ongoing rapid diffusion of Nuclear as specialists in radiochemistry and pharmacy, Medicine. physicists and other professionals. In addition, a dedicated track for technologists will be provided. In recent years, the status of the EANM Congress as the world-leading meeting in Nuclear Medicine If all of this still isn’t enough to motivate you to has been firmly established. The number of attend the EANM’20 Congress virtually, we are attendees in 2019 exceeded that in any previous working on providing some extra entertainment to year, with more than 6950 participants, but we make your virtual experience even more fun. -
Does Treatment with Duloxetine for Neuropathic Pain Impact Glycemic Control?
Clinical Care/Education/Nutrition ORIGINAL ARTICLE Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control? 1 1 THOMAS HARDY, MD, PHD MARY ARMBRUSTER, MSN, CDE betic peripheral neuropathic pain (DPNP) 2 3,4 RICHARD SACHSON, MD ANDREW J.M. BOULTON, MD, FRCP vary from 3% to Ͼ20% (4). 1 SHUYI SHEN, PHD For many agents, the data supporting effectiveness is limited. In addition, nearly all treatments are associated with OBJECTIVE — We examined changes in metabolic parameters in clinical trials of duloxetine safety or tolerability issues. One category for diabetic peripheral neuropathic pain (DPNP). of side effects common to a number of the antidepressant and anticonvulsant drugs RESEARCH DESIGN AND METHODS — Data were pooled from three similarly de- is related to metabolic changes. Weight signed clinical trials. Adults with diabetes and DPNP (n ϭ 1,024) were randomized to 60 mg ϭ gain is seen with tricyclic antidepressants duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n 867) were re-randomized (TCAs) (5) and anticonvulsants (e.g., val- to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to proate, gabapentin, pregabalin) (6). identify relationships between metabolic measures and demographic, clinical, and electrophys- Changes in plasma glucose have also been iological parameters. reported with TCAs (7,8) and phenytoin (9), and dyslipidemia can be seen with RESULTS — Duloxetine treatment resulted in modest increases in fasting plasma glucose carbamazepine (10). in short- and long-term studies (0.50 and 0.67 mmol/l, respectively).