DOCSLIB.ORG

Table of Contents

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Table of Contents ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE Bracco Diagnostics Inc. Advisory Committee Briefing Document MultiHance (gadobenate dimeglumine) ProHance (gadoteridol) Table of Contents List of Tables .................................................................................................................................. 5 List of Figures................................................................................................................................. 6 Executive Summary........................................................................................................................ 7 1 Introduction ......................................................................................................................... 12 1.1 MultiHance and ProHance: Chemical Names, Structures and Approved Indications .................................................................................................................... 12 1.2 Properties of Gadolinium-based Contrast Agents........................................................ 13 1.3 Problem Statement ....................................................................................................... 15 2 Evidence of Gd Retention in Brain and Body Tissues ........................................................ 16 2.1 Gd Retention in Brain Tissues...................................................................................... 16 2.1.1 Tissue-Sample Studies .......................................................................................... 16 2.1.1.1 Nonclinical, Tissue-Sample Studies............................................................... 16 2.1.1.1.1 Levels of Elemental Gd in Brain Tissues Following Exposure to Different GBCAs in Healthy Rats........................................................... 16 2.1.1.1.2 Levels of Elemental Gd in Brain Tissues Following Exposure to Different GBCAs in Animals with Impairment of Renal Function ........ 22 2.1.1.1.3 Possible Chemical Forms of Gd Complexes Retained in Brain Tissues Following Exposure to Different GBCAs.................................. 23 2.1.1.1.4 Retention of Gd Complexes in Brain Tissues Over Time....................... 27 2.1.1.1.5 Conclusions on Gd Retention Data from Nonclinical Tissue- Sample Studies........................................................................................ 28 2.1.1.2 Clinical Tissue-Sample Studies...................................................................... 29 2.1.1.2.1 Levels of Elemental Gd in Brain Tissues................................................ 29 2.1.1.2.2 Distribution and Speciation of Gd Deposits ........................................... 33 2.1.1.2.3 Conclusions on Gd Retention Data from Clinical Tissue-Sample Studies..................................................................................................... 33 2.1.2 Imaging Studies..................................................................................................... 36 2.1.2.1 Available Evidence ........................................................................................ 36 2.1.2.2 Conclusions on Data from Imaging Studies................................................... 40 2.1.3 Overall Conclusions on Gd Retention in Brain Tissues........................................ 40 2.2 Gd Retention in Body Tissues...................................................................................... 43 2.2.1 Nonclinical Studies ............................................................................................... 43 2.2.1.1 Levels of Elemental Gd in Skin Following Exposure to Different GBCAs in Healthy Rats ................................................................................. 43 2.2.1.2 Retention of Gd in Skin Tissues Over Time .................................................. 44 2.2.1.3 Levels of Elemental Gd in Skin Following Exposure to Different GBCAs in Animals with Impairment of Renal Function............................... 46 2.2.1.4 Levels of Elemental Gd in Bone Tissues (Femur) Following Exposure to Different GBCAs in Healthy Rats ............................................................. 46 2.2.1.5 Levels of Elemental Gd in Bone Tissues (Femur) Following Exposure to Different GBCAs in Animals with Impairment of Renal Function........... 47 Document ID: BDI-REP-A62075.17-MH_PH Br-B084686-2.0 Page 2 of 104 ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE Bracco Diagnostics Inc. Advisory Committee Briefing Document MultiHance (gadobenate dimeglumine) ProHance (gadoteridol) 2.2.1.6 Levels of Elemental Gd in Liver Following Exposure to Different GBCAs in Healthy Rats ................................................................................. 48 2.2.1.7 Levels of Elemental Gd in Liver Following Exposure to Different GBCAs in Animals with Impairment of Renal Function............................... 49 2.2.1.8 Levels of Elemental Gd in Kidney Following Exposure to Different GBCAs in Animals with Impairment of Renal Function............................... 49 2.2.1.9 Levels of Elemental Gd in Kidney Following Exposure to Different GBCAs in Animals with Impairment of Renal Function............................... 50 2.2.1.10 Conclusions on Gd Retention Data in Body Tissues from Nonclinical Tissue-Sample Studies ................................................................................... 51 2.2.2 Clinical Studies ..................................................................................................... 52 2.2.2.1 Retention in Bone........................................................................................... 52 2.2.2.2 Retention in Skin............................................................................................ 53 2.2.2.3 Retention in Liver .......................................................................................... 55 2.2.2.4 Conclusions on Clinical Body Tissue-Sample Studies .................................. 56 2.2.3 Overall Conclusions on Gd Retention in Body Tissues........................................ 57 3 Assessment of Potential Toxicity of Gd Retained in Brain and Body Tissues ................... 58 3.1.1 Acute Neurotoxicity Studies of GBCAs ............................................................... 58 3.1.2 Assessment of Neurotoxicity of Retained Gd Complexes in Animal Studies ................................................................................................................... 60 3.1.3 Assessment of Neurotoxic Potential from Clinical Data ...................................... 62 3.1.3.1 Post-mortem Tissue-Sample Studies.............................................................. 62 3.1.3.2 Imaging and Epidemiologic Studies .............................................................. 62 3.1.4 Conclusions on Potential Effects of Gd Retention in Brain Tissues..................... 68 3.2 Assessment of Potential Effects of Gd Retention in Body Tissues.............................. 69 3.2.1 Nonclinical Evidence ............................................................................................ 69 3.2.2 Clinical Evidence .................................................................................................. 71 3.2.2.1 Nephrogenic Systemic Fibrosis (NSF)........................................................... 71 3.2.2.2 Non-NSF Delayed Adverse Events................................................................ 73 3.2.2.2.1 Gadolinium-associated Plaques .............................................................. 74 3.2.2.2.2 Gadolinium-Deposition Disease ............................................................. 74 3.2.2.2.3 Case Report of Joint Contractures in a Patient with Normal Renal Function .................................................................................................. 76 3.2.2.3 Conclusions on Potential Effects of Gd Retention in Body Tissues.............. 77 4 Benefit-Risk Balance of MultiHance .................................................................................. 78 4.1 Assessment of Clinical Benefit Provided by MultiHance............................................ 79 4.1.1 MRI of the CNS .................................................................................................... 80 4.1.2 MR Angiography (MRA)...................................................................................... 80 4.1.3 Conclusion on the Clinical Benefit of MultiHance in the Approved Indications ............................................................................................................. 81 4.2 Assessment of Clinical Benefit Provided by ProHance ............................................... 81 4.3 Risk Assessment........................................................................................................... 82 4.3.1 Immediate-type Hypersensitivity Reactions ......................................................... 82 4.3.2 Nephrogenic Systemic Fibrosis (NSF).................................................................. 83 Document ID: BDI-REP-A62075.17-MH_PH Br-B084686-2.0 Page 3 of 104 ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE Bracco Diagnostics Inc. Advisory Committee Briefing Document MultiHance (gadobenate dimeglumine) ProHance (gadoteridol) 4.3.3 Gadolinium Retention in Brain and Body Tissues................................................ 83 4.3.3.1 T1 Hyperintensity in Deep Brain Areas......................................................... 83
Load more

Recommended publications
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE
    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE
    [Show full text]
  • Imaging Diagnostics by Combining Contrast Agents
    (19) TZZ Z _T (11) EP 2 907 526 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 19.08.2015 Bulletin 2015/34 A61K 49/04 (2006.01) A61K 51/04 (2006.01) A61K 49/06 (2006.01) (21) Application number: 15155866.5 (22) Date of filing: 20.06.2008 (84) Designated Contracting States: (72) Inventor: Wiebelitz, Ulrike AT BE BG CH CY CZ DE DK EE ES FI FR GB GR 13158 Berlin (DE) HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR (74) Representative: Kilger, Ute Boehmert & Boehmert (30) Priority: 22.06.2007 EP 07110922 Anwaltspartnerschaft mbB Patentanwälte Rechtsanwälte (62) Document number(s) of the earlier application(s) in Pettenkoferstrasse 20-22 accordance with Art. 76 EPC: 80336 München (DE) 12199299.4 / 2 572 735 12168380.9 / 2 514 442 Remarks: 08774183.1 / 2 170 405 This application was filed on 20-02-2015 as a divisional application to the application mentioned (71) Applicant: mivenion GmbH under INID code 62. 10115 Berlin (DE) (54) Imaging diagnostics by combining contrast agents (57) The present invention relates to the use of a combination of several contrast agents having different imaging properties with respect to imaging representation. EP 2 907 526 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 907 526 A1 2 Description from suspect lesions and to prepare and assess these samples histopathologically. [0001] The present invention relates to the use of a [0005] MRI examination of the female breast has very combination of several contrast agents having different high sensitivity in comparison to other imaging modali- imaging properties.
    [Show full text]
  • Drug-Induced Anaphylaxis in China: a 10 Year Retrospective Analysis of The
    Int J Clin Pharm DOI 10.1007/s11096-017-0535-2 RESEARCH ARTICLE Drug‑induced anaphylaxis in China: a 10 year retrospective analysis of the Beijing Pharmacovigilance Database Ying Zhao1,2,3 · Shusen Sun4 · Xiaotong Li1,3 · Xiang Ma1 · Huilin Tang5 · Lulu Sun2 · Suodi Zhai1 · Tiansheng Wang1,3,6 Received: 9 May 2017 / Accepted: 19 September 2017 © The Author(s) 2017. This article is an open access publication Abstract Background Few studies on the causes of (50.1%), mucocutaneous (47.4%), and gastrointestinal symp- drug-induced anaphylaxis (DIA) in the hospital setting are toms (31.3%). A total of 249 diferent drugs were involved. available. Objective We aimed to use the Beijing Pharma- DIAs were mainly caused by antibiotics (39.3%), traditional covigilance Database (BPD) to identify the causes of DIA Chinese medicines (TCM) (11.9%), radiocontrast agents in Beijing, China. Setting Anaphylactic case reports from (11.9%), and antineoplastic agents (10.3%). Cephalospor- the BPD provided by the Beijing Center for Adverse Drug ins accounted for majority (34.5%) of antibiotic-induced Reaction Monitoring. Method DIA cases collected by the anaphylaxis, followed by fuoroquinolones (29.6%), beta- BPD from January 2004 to December 2014 were adjudi- lactam/beta-lactamase inhibitors (15.4%) and penicillins cated. Cases were analyzed for demographics, causative (7.9%). Blood products and biological agents (3.1%), and drugs and route of administration, and clinical signs and plasma substitutes (2.1%) were also important contributors outcomes. Main outcome measure Drugs implicated in DIAs to DIAs. Conclusion A variety of drug classes were impli- were identifed and the signs and symptoms of the DIA cases cated in DIAs.
    [Show full text]
  • 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.
    [Show full text]
  • Magnetic Resonance Imaging (MRI) Contrast Agents Frequently Asked Questions
    Magnetic Resonance Imaging (MRI) Contrast Agents Frequently Asked Questions 1. What is an MRI contrast agent? MRI contrast agents are chemical substances that contain the metal gadolinium. They are injected through a vein for many magnetic resonance imaging (MRI) scans. 2. What are the benefits of MRI contrast agents? When injected through a vein into the body, MRI contrast agents improve how internal organs, blood vessels, and other tissues look on the MRI images. This helps detect problems and diagnose medical conditions. For many medical conditions, the use of MRI contrast agents is a necessary part of the MRI. 3. What are the risks from MRI contrast agents? A. Injection problems. Any injection can cause injury to a nerve, artery, or vein, or result in infection. The contrast agent can also sometimes leak outside of the vein into the soft tissues during injection. This is called extravasation and is uncommon (about 1 in every 1,000 injections). This may be painful, but the pain is generally relieved by cold or warm compresses. B. Allergic reaction. Some people can be allergic to MRI contrast agents. There can sometimes be a mild reaction to the contrast agent such as itching and hives (about 1 in every 100 injections). Uncommonly, there can be a serious reaction to the contrast agent such as changes in blood pressure, cardiac distress, and respiratory distress (about 1 in every 10,000 injections). Very rarely this can result in death. For patients who have had a previous mild allergic reaction to an MRI contrast agent and need another MRI with MRI contrast agent, it is generally safe to do so after taking anti-allergy medications.
    [Show full text]
  • The Choice of Gadolinium-Based Contrast Agents: a Radiologist’S Responsibility Between Pharmaceutical Equivalence and Bioethical Issues
    S S symmetry Article The Choice of Gadolinium-Based Contrast Agents: A Radiologist’s Responsibility between Pharmaceutical Equivalence and Bioethical Issues Gaia Cartocci 1, Alessandro Santurro 1 ID , Raffaele La Russa 1,2 ID , Giuseppe Guglielmi 3,4, Paola Frati 1,2 and Vittorio Fineschi 1,2,* 1 Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Viale Regina Elena 336, 00185 Rome (RM), Italy; [email protected] (G.C.); [email protected] (A.S.); [email protected] (R.L.R.); [email protected] (P.F.) 2 IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli (IS), Italy 3 Department of Radiology, University of Foggia, Viale Luigi Pinto 1, 71100 Foggia (FG), Italy; [email protected] 4 Department of Radiology, Scientific Institute “Casa Sollievo della Sofferenza” Hospital, San Giovanni Rotondo, Viale Cappuccini 1, 71013 San Giovanni Rotondo (FG), Italy * Correspondence: vfi[email protected]; Tel.: +39-06-49912-722; Fax: +39-06-4455-335 Received: 24 October 2017; Accepted: 17 November 2017; Published: 22 November 2017 Abstract: Contrast Agents (CA) are among the most commonly prescribed drugs worldwide, and are used, with a variety of techniques, to increase and intensify the differences between body tissues and to help radiologist make diagnoses in a fast and precise way. In recent decades, advancements in research have resulted in significant improvements in their composition, and have made them safer and better-tolerated by patients; this notwithstanding, although the currently available CA are generally considered to be safe, their use is not completely without risk. The use of CA faces the radiologist with economic considerations, bioethical dilemmas, and possible profiles of professional responsibility.
    [Show full text]
  • ACR Manual on Contrast Media
    ACR Manual On Contrast Media 2021 ACR Committee on Drugs and Contrast Media Preface 2 ACR Manual on Contrast Media 2021 ACR Committee on Drugs and Contrast Media © Copyright 2021 American College of Radiology ISBN: 978-1-55903-012-0 TABLE OF CONTENTS Topic Page 1. Preface 1 2. Version History 2 3. Introduction 4 4. Patient Selection and Preparation Strategies Before Contrast 5 Medium Administration 5. Fasting Prior to Intravascular Contrast Media Administration 14 6. Safe Injection of Contrast Media 15 7. Extravasation of Contrast Media 18 8. Allergic-Like And Physiologic Reactions to Intravascular 22 Iodinated Contrast Media 9. Contrast Media Warming 29 10. Contrast-Associated Acute Kidney Injury and Contrast 33 Induced Acute Kidney Injury in Adults 11. Metformin 45 12. Contrast Media in Children 48 13. Gastrointestinal (GI) Contrast Media in Adults: Indications and 57 Guidelines 14. ACR–ASNR Position Statement On the Use of Gadolinium 78 Contrast Agents 15. Adverse Reactions To Gadolinium-Based Contrast Media 79 16. Nephrogenic Systemic Fibrosis (NSF) 83 17. Ultrasound Contrast Media 92 18. Treatment of Contrast Reactions 95 19. Administration of Contrast Media to Pregnant or Potentially 97 Pregnant Patients 20. Administration of Contrast Media to Women Who are Breast- 101 Feeding Table 1 – Categories Of Acute Reactions 103 Table 2 – Treatment Of Acute Reactions To Contrast Media In 105 Children Table 3 – Management Of Acute Reactions To Contrast Media In 114 Adults Table 4 – Equipment For Contrast Reaction Kits In Radiology 122 Appendix A – Contrast Media Specifications 124 PREFACE This edition of the ACR Manual on Contrast Media replaces all earlier editions.
    [Show full text]
  • Gadolinium Based Contrast Agents
    CE Credits Available CONSIDERATIONS IN THE SELECTION OF A NEW GADOLINIUM-BASED CONTRAST AGENT SUPPLEMENT TO MAY 2014 THE JOURNAL OF PRACTICAL MEDICAL IMAGING AND MANAGEMENT Considerations in the Selection of a New Gadolinium-Based Contrast Agent Michael F. Tweedle, PhD Emanuel Kanal, MD, FACR, FISMRM Robert Muller, PhD Stefanie Spielman Professor of Radiology Professor of Radiology and Neuroradiology Department of General, Organic & The Ohio State University University of Pittsburgh Medical Center Biochemical Chemistry Columbus, OH Pittsburgh, PA University of Mons Mons, Belgium Supported by an unrestricted educational grant from © May 2014 www.appliedradiology.com SUPPLEMENT TO APPLIED RADIOLOGY n 1 Publisher Kieran Anderson Executive Editor Cristen Bolan Art and Production Barbara A. Shopiro Applied Radiology and this supplement, Considerations in the Selection of a New Gadolinium-Based Contrast Agent, are published by Anderson Publishing, Ltd. The journal does not warrant the expertise of any author in a particular field, nor is it responsible for any statements by such authors. The opinions expressed in this supplement are those of the authors. They do not imply endorsement of advertised products and do not necessarily reflect the opinions or recommendations of our sponsors or the editors and staff of Applied Radiology. Copyright © 2014 by Anderson Publishing, Ltd., 180 Glenside Avenue, Scotch Plains, NJ 07076 All rights reserved. Cover images courtesy of Howard A. Rowley, MD. Considerations in the Selection of a New Gadolinium-Based Contrast Agent Our 3 esteemed faculty summarize the similarities and differences among the gadolinium-based contrast agents (GBCAs) currently utilized for magnetic resonance imaging (MRI), with emphasis on stability and relaxivity.
    [Show full text]
  • DISSERTATION INVESTIGATION of CATIONIC CONTRAST-ENHANCED COMPUTED TOMOGRAPHY for the EVALUATION of EQUINE ARTICULAR CARTILAGE Su
    DISSERTATION INVESTIGATION OF CATIONIC CONTRAST-ENHANCED COMPUTED TOMOGRAPHY FOR THE EVALUATION OF EQUINE ARTICULAR CARTILAGE Submitted by Bradley B. Nelson Department of Clinical Sciences In partial fulfillment of the requirements For the Degree of Doctor of Philosophy Colorado State University Fort Collins, Colorado Fall 2017 Doctoral Committee: Advisor: Christopher E. Kawcak Co-Advisor: Laurie R. Goodrich C. Wayne McIlwraith Mark W. Grinstaff Myra F. Barrett Copyright by Bradley Bernard Nelson 2017 All Rights Reserved ABSTRACT INVESTIGATION OF CATIONIC CONTRAST-ENHANCED COMPUTED TOMOGRAPHY FOR THE EVALUATION OF EQUINE ARTICULAR CARTILAGE Osteoarthritis and articular cartilage injury are substantial problems in horses causing joint pain, lameness and decreased athleticism resonant of the afflictions that occur in humans. This debilitating joint disease causes progressive articular cartilage degeneration and coupled with a poor capacity to heal necessitates that articular cartilage injury is detected early before irreparable damage ensues. The use of diagnostic imaging is critical to identify and characterize articular cartilage injury, though currently available methods are unable to identify these early degenerative changes. Cationic contrast-enhanced computed tomography (CECT) uses a cationic contrast media (CA4+) to detect the early molecular changes that occur in the extracellular matrix. Glycosaminoglycans (GAGs) within the extracellular matrix are important for the providing the compressive stiffness of articular cartilage and their degradation is an early event in the development of osteoarthritis. Cationic CECT imaging capitalizes on the electrostatic attraction between CA4+ and GAGs; exposing the proportional relationship between the amount of GAGs present within and the amount of CA4+ that diffuses into the tissue. The amount of CA4+ that resides in the tissue is then quantified through CECT imaging and estimates tissue integrity through nondestructive assessment.
    [Show full text]
  • Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017
    Dotarem® (gadoterate meglumine) Injection – NDA# 204781 Advisory Committee Optimark® (gadoversetamide) Injection - NDAs# 020937, 020975 & 020976 Briefing Document Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017 DOTAREM® (gadoterate meglumine) Injection NDA 204781 Guerbet LLC, 821 Alexander Rd, Princeton, NJ 08540 OPTIMARK® (gadoversetamide) Injection NDAs 020937, 020975 & 020976 Liebel-Flarsheim Company LLC, 1034 Brentwood Blvd., Richmond Heights, MO 63117 ADVISORY COMMITTEE BRIEFING MATERIALS AVAILABLE FOR PUBLIC RELEASE Information provided within this briefing document is based upon medical and scientific information available to date. ADVISORY COMMITTEE BRIEFING MATERIALS AVAILABLE FOR PUBLIC RELEASE Page 1 / 168 Dotarem® (gadoterate meglumine) Injection – NDA# 204781 Advisory Committee Optimark® (gadoversetamide) Injection - NDAs# 020937, 020975 & 020976 Briefing Document EXECUTIVE SUMMARY Gadolinium-based contrast agents (GdCAs) are essential for use in magnetic resonance imaging (MRI). Although non-contrast-enhanced MRI may be sufficient for use in some clinical conditions, contrast-enhanced MRI (CE-MRI) using GdCA provides additional vital diagnostic information in a number of diseases. It is widely recognized that CE-MRI increases diagnostic accuracy and confidence, and thus can impact the medical and/or surgical management of patients. Based on the chemical structure of the complexing ligand, GdCA are classified as linear (L-GdCA) or macrocyclic (M-GdCA) and can be ionic or nonionic and those characteristics have a dramatic influence on the stability of the GdCA. Dotarem®, a M-GdCA, was first approved in France in 1989. US-FDA approval was obtained in March 2013 for “intravenous use with MRI of the brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity”, at the dose of 0.1 mmol/kg BW.
    [Show full text]
  • Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
    MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01
    [Show full text]
  • 2012 CKD Guideline
    OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease VOLUME 3 | ISSUE 1 | JANUARY 2013 http://www.kidney-international.org KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease KDIGO gratefully acknowledges the following consortium of sponsors that make our initiatives possible: Abbott, Amgen, Bayer Schering Pharma, Belo Foundation, Bristol-Myers Squibb, Chugai Pharmaceutical, Coca-Cola Company, Dole Food Company, Fresenius Medical Care, Genzyme, Hoffmann-LaRoche, JC Penney, Kyowa Hakko Kirin, NATCO—The Organization for Transplant Professionals, NKF-Board of Directors, Novartis, Pharmacosmos, PUMC Pharmaceutical, Robert and Jane Cizik Foundation, Shire, Takeda Pharmaceutical, Transwestern Commercial Services, Vifor Pharma, and Wyeth. Sponsorship Statement: KDIGO is supported by a consortium of sponsors and no funding is accepted for the development of specific guidelines. http://www.kidney-international.org contents & 2013 KDIGO VOL 3 | ISSUE 1 | JANUARY (1) 2013 KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease v Tables and Figures vii KDIGO Board Members viii Reference Keys x CKD Nomenclature xi Conversion Factors & HbA1c Conversion xii Abbreviations and Acronyms 1 Notice 2 Foreword 3 Work Group Membership 4 Abstract 5 Summary of Recommendation Statements 15 Introduction: The case for updating and context 19 Chapter 1: Definition, and classification
    [Show full text]