DOCSLIB.ORG

Technetium-99M Pharmaceuticals

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Technetium-99M Pharmaceuticals Ilse Zolle Editor Technetium-99m Pharmaceuticals Gedruckt mit Unterstçtzung des Bundesministeriums fçr Bildung, Wissenschaft und Kultur in Wien und der Kulturabteilung der Stadt Wien, Wissenschafts- und Forschungsfærderung Ilse Zolle Editor Technetium-99m Pharmaceuticals Preparation and Quality Control in Nuclear Medicine With 66 Figures and 29 Tables 12 Ilse Zolle Department of Medicinal/Pharmaceutical Chemistry University of Vienna Althanstraûe 14 1090 Vienna Austria Library of Congress Control Number 2006925440 ISBN-10 3-540-33989-2 Springer Berlin Heidelberg New York ISBN-13 978-3-540-33989-2 Springer Berlin Heidelberg New York This work is subject to copyright. All rights are reserved, whether the whole or part of the material is con- cerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproducti- on on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current versi- on, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law. Springer is a part of Springer Science+Business Media springer.com ° Springer Berlin Heidelberg 2007 The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publishers cannot guarantee the accuracy of any information about the application of operative techniques and medications contained in this book. In every individual case the user must check such information by consulting the relevant literature. Editor: Dr. Ute Heilmann Desk Editor: Wilma McHugh Production: LE-TEX Jelonek, Schmidt & Væckler GbR, Leipzig Typesetting: K + V Fotosatz, Beerfelden, Germany Cover: Frido Steinen-Broo, eStudio Calamar, Spain Printed on acid-free paper 21/3100/YL 5 4 3 2 1 0 Foreword Some persons have thought that the increasing emphasis and development of positron- emitting radiotracers in nuclear medicine would result in a decrease in the develop- ment and use of single photon-emitting radiotracers. That this is not the case is illu- strated by the fact that there were 302 presentations involving technetium-99m at the June 2006 annual meeting of the Society of Nuclear Medicine in the United States. Io- dine-123 accounted for 88 presentations, and indium-111 for 81. Among the most recent advances in the fusion of nuclear medicine images with computed tomography (SPECT/CT) and computed tomography angiography (SPECT/ CTA) in basic science studies in small animals, SPECT/CT was the topic of 11 instru- mentation presentations, while PET/CT in small animals accounted for 5 presentations. The success of molecular imaging in medicine and biomedical research is the result of the diversity of imaging technologies, the integrating and collaboration of imaging and pharmaceutical development experts, and friendly competitition. The advantage of single photon tracers is that many of them, such as technetium-99m, emit only photons, rather than positrons or negative beta particles that increase the radiation exposure of the patient and limit the doses of the tracers that can be administered with acceptable radiation exposure. Also, the range of positrons in tissue before they encounter an electron and emit 511 keV photons limits the spatial resolution that can be obtained in living animals and patients. Theoretically, the spatial resolution of single photon tracer studies is limitless, especially with the use of special pinhole collimation. Radioactive tracers used in medicine today provide information, and need to be judged by how reliably they provide this information. Some of the safeguards built into the drug review process by the FDA for regulating pharmaceuticals are not needed in the case of the mass of injected material used in radiopharmaceuticals. With radiophar- maceuticals, the criterion should be whether the information provided by the diagnos- tic procedure is valid and valuable. Today, we need to promote a ªfast trackº regulatory approval process to make diag- nostic procedures more readily available. A major difference between therapeutic and diagnostic drugs is that the efficacy of the diagnostic procedure in providing the re- quired information can be assessed shortly after the performance of the imaging proce- dure. The patients do not need to be followed for longer periods of time to identify any untoward side effects. Multi-institutional randomized control studies can determine whether the procedure provides the diagnostic information provided by the study, as well as identify any untoward side-effects. Radiotracers, by definition, have no effect on the patients' biochemistry or body functions, which should be a major simplifying factor along the road to their regula- tory approval. There is ever-increasing evidence of their great value in answering the questions: What is wrong? What is going to happen? What can be done about it? How did it happen? This book covers the past, present and future of single photon tracers in medical practice and biomedical research. It is likely to become a standard textbook for those persons entering the exciting career of a radiopharmacist or researcher in biomedical research using radioactive tracers. VI Foreword The pathway to assuring the safe and effective use of short-lived radiotracers is to place the responsibility for quality assurance in the hands of nuclear pharmacists who fill physician's prescriptions for radiotracers as they do for other drugs under state pharmacy laws. Radiochemists or others working in institutions with radiopharmacies must have the expertise for the preparation of the radiotracers as well as for quality control under good manufacturing practices. This book provides guidance and safety standards applicable to Tc-99m pharmaceuticals. Baltimore, June 2006 Henry N. Wagner, Jr. M.D. Foreword Viewpoint of the Clinician Radiopharmaceuticals labeled with 99mTc are commercially available and are employed in more than 80% of all nuclear medicine investigations. Among the radionuclides, technetium-99m is most attractive to the nuclear medicine physician because of its op- timal gamma energy for SPECT, its availability, its relatively low cost, and its easy-to-la- bel kit preparations for in-house use. Another advantage is the low radiation burden to patients, due primarily to its short half-life. The decay within hours also facilitates the handling of waste. Professor Dr. Ilse Zolle ± together with other leading international radiochemists and radiopharmacists ± made an effort to collect the available data on 99mTc-labeled compounds with respect to their chemistry, labeling methods, quality control proce- dures and clinical applications. The comprehensive text is presented in two parts. The first part comprises chapters on technetium compounds in medicine, including ad- vances in labeling biomolecules with technetium, the advantages of sterile kit formula- tions, and analytical methods to verify pharmaceutical quality. Emphasis is given to the rules governing the manufacture of radiopharmaceuticals and the importance of specifications given by the pharmacopoeia, which are obligatory. A special chapter is devoted to the performance of the 99Mo/99mTc generator and to the characteristics of the 99mTc eluate. For the clinician, Part II offers 25 monographs relating to 99mTc-pharmaceuticals, which describe the pharmaceutical particulars of each radiotracer as well as relevant information on its clinical application, concerning the pharmaceutical dosage, contra- indications and interference with other pharmaceuticals, quality control, pharmacoki- netic data, radiation dose and valuable references. In addition, recommendations for storage and criteria of stability are also given. The multidisciplinary properties of 99mTc-pharmaceuticals are presented in the form of a highly structured text with informative tables, which enables the clinician to find clinically relevant data very easily. The book should therefore not only be recommended for radiochemists and radio- pharmacists, but also for nuclear medicine physicians using 99mTc-labeled pharmaceuti- cals in daily practice. Wçrzburg, July 2006 Christoph Reiners Preface 99mTc pharmaceuticals mark the beginning of diagnostic nuclear medicine and have contributed to patient care worldwide. Since the short-lived radionuclide was intro- duced for thyroid imaging in 1964, it has attracted much attention and stimulated clini- cal research. Little was known about element 43, except that it was an artificial radio- nuclide obtained by the radioactive decay of molybdenum-99. No wonder specialists from all fields joined medical institutions in the United States to participate in the ex- ploration of its chemistry. This textbook gives an account of the accomplishments related to the development of 99mTc pharmaceuticals and their application in diagnostic nuclear medicine. Since radioactive drug development is a multidisciplinary task, experts working in nuclear medicine and research institutions have contributed valuable information concerning the preparation with sterile kits, methods of quality control, and the use of 99mTc phar- maceuticals in patients. In addition, the legal aspects governing production
Load more

Recommended publications
  • Radioisotopes and Radiopharmaceuticals
    RADIOISOTOPES AND RADIOPHARMACEUTICALS Radioisotopes are the unstable form of an element that emits radiation to become a more stable form — they have certain special attributes. These make radioisotopes useful in areas such as medicine, where they are used to develop radiopharmaceuticals, as well as many other industrial applications. THE PRODUCTION OF TECHNETIUM-99m RADIOPHARMACEUTICALS: ONE POSSIBLE ROUTE IRRADIATED U-235 99 TARGETS MO PROCESSING FACILITY HOSPITAL RADIOPHARMACY (MIXING WITH BIOLOGICAL MOLECULES THAT BIND AT DIFFERENT LOCATIONS IN THE 99mTC IS IDEAL FOR DIAGNOSTICS BECAUSE OF BODY, SUPPORTING A WIDE ITS SHORT HALF-LIFE (6 HOURS) AND IDEAL GAMMA EMISSION RANGE OF MEDICAL NUCLEAR APPLICATIONS) REACTOR: 6 HOURS MAKES DISTRIBUTION DIFFICULT 99MO BULK LIQUID TARGET ITS PARENT NUCLIDE, MOLYBDENUM-99, IS PRODUCED; ITS HALF-LIFE (66 HOURS) MAKES 99 99m IRRADIATION IT SUITABLE FOR TRANSPORT MO/ TC GENERATORS 99MO/99mTC GENERATORS ARE PRODUCED AND DISTRIBUTED AROUND THE GLOBE 99MO/99TC GENERATOR MANUFACTURER Radioisotopes can occur naturally or be produced artificially, mainly in research reactors and accelerators. They are used in various fields, including nuclear medicine, where radiopharmaceuticals play a major role. Radiopharmaceuticals are substances that contain a radioisotope, and have properties that make them effective markers in medical diagnostic or therapeutic procedures. The chemical presence of radiopharmaceuticals can relay detailed information to medical professionals that can help in diagnoses and treatments. Eighty percent of all diagnostic medical scans worldwide use 99mTc, and its availability, at present, is dependent on the production of 99Mo in research reactors. Globally, the number of medical procedures involving the use of radioisotopes is growing, with an increasing emphasis on radionuclide therapy using radiopharmaceuticals for the treatment of cancer..
    [Show full text]
  • OPERATIONAL GUIDANCE on HOSPITAL RADIOPHARMACY: a SAFE and EFFECTIVE APPROACH the Following States Are Members of the International Atomic Energy Agency
    OPERATIONAL GUIDANCE ON HOSPITAL RADIOPHARMACY: A SAFE AND EFFECTIVE APPROACH The following States are Members of the International Atomic Energy Agency: AFGHANISTAN GUATEMALA PAKISTAN ALBANIA HAITI PALAU ALGERIA HOLY SEE PANAMA ANGOLA HONDURAS PARAGUAY ARGENTINA HUNGARY PERU ARMENIA ICELAND PHILIPPINES AUSTRALIA INDIA POLAND AUSTRIA INDONESIA PORTUGAL AZERBAIJAN IRAN, ISLAMIC REPUBLIC OF QATAR BANGLADESH IRAQ REPUBLIC OF MOLDOVA BELARUS IRELAND ROMANIA BELGIUM ISRAEL RUSSIAN FEDERATION BELIZE ITALY SAUDI ARABIA BENIN JAMAICA SENEGAL BOLIVIA JAPAN SERBIA BOSNIA AND HERZEGOVINA JORDAN SEYCHELLES BOTSWANA KAZAKHSTAN BRAZIL KENYA SIERRA LEONE BULGARIA KOREA, REPUBLIC OF SINGAPORE BURKINA FASO KUWAIT SLOVAKIA CAMEROON KYRGYZSTAN SLOVENIA CANADA LATVIA SOUTH AFRICA CENTRAL AFRICAN LEBANON SPAIN REPUBLIC LIBERIA SRI LANKA CHAD LIBYAN ARAB JAMAHIRIYA SUDAN CHILE LIECHTENSTEIN SWEDEN CHINA LITHUANIA SWITZERLAND COLOMBIA LUXEMBOURG SYRIAN ARAB REPUBLIC COSTA RICA MADAGASCAR TAJIKISTAN CÔTE D’IVOIRE MALAWI THAILAND CROATIA MALAYSIA THE FORMER YUGOSLAV CUBA MALI REPUBLIC OF MACEDONIA CYPRUS MALTA TUNISIA CZECH REPUBLIC MARSHALL ISLANDS TURKEY DEMOCRATIC REPUBLIC MAURITANIA UGANDA OF THE CONGO MAURITIUS UKRAINE DENMARK MEXICO UNITED ARAB EMIRATES DOMINICAN REPUBLIC MONACO UNITED KINGDOM OF ECUADOR MONGOLIA GREAT BRITAIN AND EGYPT MONTENEGRO NORTHERN IRELAND EL SALVADOR MOROCCO ERITREA MOZAMBIQUE UNITED REPUBLIC ESTONIA MYANMAR OF TANZANIA ETHIOPIA NAMIBIA UNITED STATES OF AMERICA FINLAND NEPAL URUGUAY FRANCE NETHERLANDS UZBEKISTAN GABON NEW ZEALAND VENEZUELA GEORGIA NICARAGUA VIETNAM GERMANY NIGER YEMEN GHANA NIGERIA ZAMBIA GREECE NORWAY ZIMBABWE The Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of the IAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. The Headquarters of the Agency are situated in Vienna.
    [Show full text]
  • Azedra) Reference Number: ERX.SPA.420 Effective Date: 03.01.21 Last Review Date: 02.21 Line of Business: Commercial, Medicaid Revision Log
    Clinical Policy: Iobenguane I-131 (Azedra) Reference Number: ERX.SPA.420 Effective Date: 03.01.21 Last Review Date: 02.21 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Iobenguane I-131 (Azedra®) injection is a radioactive agent. FDA Approved Indication(s) Azedra is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. Health plan approved formularies should be reviewed for all coverage determinations. Requirements to use preferred alternative agents apply only when such requirements align with the health plan approved formulary. It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Azedra is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Pheochromocytoma and Paraganglioma (must meet all): 1. Diagnosis of pheochromocytoma or paraganlioma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 12 years; 4. Tumor is unresectable, locally advanced, or metastatic; 5. Member currently receives medication to control tumor secretion of catecholamines (e.g., epinephrine, norepinephrine, dopamine) and related symptoms (e.g., hypertension, arrhythmia, hyperglycemia); 6. Metaiodobenzylguanidine (MIBG) scan is positive; 7. Concurrent radiopharmaceuticals have not been prescribed (e.g., Lutathera® [lutetium lu-177 dotatate]); 8. Request meets one of the following (a or b):* a. Dose does not exceed (i or ii): i.
    [Show full text]
  • COMMENT (11) Status: Pending Post PUBLIC SUBMISSION PUBLICATION Tracking No
    Page 1 of 2 SUNSI Review Complete Template = ADM-013 E-RIDS=ADM-03 ADD: Jazel Parks, As of: 10/1/19 1:22 PM Harriet Karagiannis Received: September 25, 2019 COMMENT (11) Status: Pending_Post PUBLIC SUBMISSION PUBLICATION Tracking No. 1k3-9ce3-dnzr DATE: 7/26/2019 Comments Due: September 26, 2019 CITATION 84 FR Submission Type: Web 36127 Docket: NRC-2019-0154 Release of Patients Administered Radioactive Material Comment On: NRC-2019-0154-0003 Release of Patients Administered Radioactive Material; Extension of comment period Document: NRC-2019-0154-DRAFT-0012 Comment on FR Doc # 2019-17060 Submitter Information Name: Daniel Miron Address: W176S8019 Joel Drive Muskego, WI, 53150 Email: [email protected] General Comment I am pleased to comment on the draft regulatory guide (DG), DG-8057, Release of Patients Administered Radioactive Material that was published in the Federal Register on July 26, 2019. (Docket ID NRC-2019- 0154). I am a health physicist who is certified by the American Board of Health Physics and have over 25 years of health physics experience in medical health physics. This includes being the Radiation Safety Officer (RSO) on multiple limited scope and broad scope medical licenses. I recommend that the data for I-123 NaI in table 3 Activities of Radiopharmaceuticals That Require Instructions and Records When Administered to Patients Who Are Breastfeeding an Infant or Child be reviewed and updated to reflect the current clinical use of I-123 NaI. Specifically the recommended duration of interruption of breastfeeding should be changed to Complete cessation due to the reasons listed below.
    [Show full text]
  • The Evolving Landscape of Therapeutic and Diagnostic Radiopharmaceuticals
    ARTICLE THE EVOLVING LANDSCAPE OF THERAPEUTIC AND DIAGNOSTIC RADIOPHARMACEUTICALS Therapeutic and diagnostic approaches involving the use of radiation and radioactive compounds have a long- standing history in the fields of science and medicine. Radiotherapy was first used in cancer treatments in 1896.1 Since then, the field of radiation has advanced to further understand how radioactive compounds interact with biological tissues and how they can be used in both diagnostic and therapeutic applications. Radiopharmaceuticals are compounds used for medicinal purposes that contain radioactive isotopes (also known as radionuclides) and can be diagnostic or therapeutic in nature, or both.2 They represent a unique category of pharmaceuticals due to their radioactive properties. As such, there are specific guidelines and regulations that impact and direct the study and use of these compounds. Radiopharmaceutical drug development has rapidly expanded over the last decade. Radiopharmaceuticals are widely used in the field of imaging for diagnosis, staging, and follow up; in the realm of therapeutics, their use has increased, most notably, in the area of oncology. In a recent webinar, experts from Medpace’s radiation oncology, imaging, regulatory, and operational teams discussed the growing space of radiopharmaceutical development with respect to their biological use and application, regulatory frameworks that govern their evaluation in support of approvals, operational manufacturing considerations, and associated imaging approaches. BIOLOGICAL MECHANISMS OF ACTION OF RADIONUCLIDES According to Dr. Jess Guarnaschelli, Medical Director, Radiation Oncology, the radioactivity of radionuclides can be employed for both diagnostic and therapeutic medical uses. While external beam ionizing radiation involves radiation emitted in the form of electromagnetic waves or particles, radiopharmaceuticals use radionuclides to deliver localized radiation to specific targets.
    [Show full text]
  • Chapter 12 Monographs of 99Mtc Pharmaceuticals 12
    Chapter 12 Monographs of 99mTc Pharmaceuticals 12 12.1 99mTc-Pertechnetate I. Zolle and P.O. Bremer Chemical name Chemical structure Sodium pertechnetate Sodium pertechnetate 99mTc injection (fission) (Ph. Eur.) Technetium Tc 99m pertechnetate injection (USP) 99m ± Pertechnetate anion ( TcO4) 99mTc(VII)-Na-pertechnetate Physical characteristics Commercial products Ec=140.5 keV (IT) 99Mo/99mTc generator: T1/2 =6.02 h GE Healthcare Bristol-Myers Squibb Mallinckrodt/Tyco Preparation Sodium pertechnetate 99mTc is eluted from an approved 99Mo/99mTc generator with ster- ile, isotonic saline. Generator systems differ; therefore, elution should be performed ac- cording to the manual provided by the manufacturer. Aseptic conditions have to be maintained throughout the operation, keeping the elution needle sterile. The total eluted activity and volume are recorded at the time of elution. The resulting 99mTc ac- tivity concentration depends on the elution volume. Sodium pertechnetate 99mTc is a clear, colorless solution for intravenous injection. The pH value is 4.0±8.0 (Ph. Eur.). Description of Eluate 99mTc eluate is described in the European Pharmacopeia in two specific monographs de- pending on the method of preparation of the parent radionuclide 99Mo, which is generally isolated from fission products (Monograph 124) (Council of Europe 2005a), or produced by neutron activation of metallic 98Mo-oxide (Monograph 283) (Council of Europe 2005b). Sodium pertechnetate 99mTc injection solution satisfies the general requirements of parenteral preparations stated in the European Pharmacopeia (Council of Europe 2004). The specific activity of 99mTc-pertechnetate is not stated in the Pharmacopeia; however, it is recommended that the eluate is obtained from a generator that is eluted regularly, 174 12.1 99mTc-Pertechnetate every 24 h.
    [Show full text]
  • An EANM Procedural Guideline
    European Journal of Nuclear Medicine and Molecular Imaging https://doi.org/10.1007/s00259-018-4052-x GUIDELINES Clinical indications, image acquisition and data interpretation for white blood cells and anti-granulocyte monoclonal antibody scintigraphy: an EANM procedural guideline A. Signore1 & F. Jamar2 & O. Israel3 & J. Buscombe4 & J. Martin-Comin5 & E. Lazzeri6 Received: 27 April 2018 /Accepted: 6 May 2018 # The Author(s) 2018 Abstract Introduction Radiolabelled autologous white blood cells (WBC) scintigraphy is being standardized all over the world to ensure high quality, specificity and reproducibility. Similarly, in many European countries radiolabelled anti-granulocyte antibodies (anti-G-mAb) are used instead of WBC with high diagnostic accuracy. The EANM Inflammation & Infection Committee is deeply involved in this process of standardization as a primary goal of the group. Aim The main aim of this guideline is to support and promote good clinical practice despite the complex environment of a national health care system with its ethical, economic and legal aspects that must also be taken into consideration. Method After the standardization of the WBC labelling procedure (already published), a group of experts from the EANM Infection & Inflammation Committee developed and validated these guidelines based on published evidences. Results Here we describe image acquisition protocols, image display procedures and image analyses as well as image interpre- tation criteria for the use of radiolabelled WBC and monoclonal antigranulocyte antibodies. Clinical application for WBC and anti-G-mAb scintigraphy is also described. Conclusions These guidelines should be applied by all nuclear medicine centers in favor of a highly reproducible standardized practice. Keywords Infection .
    [Show full text]
  • Learn More About X-Rays, CT Scans and Mris (Pdf)
    What is the difference between X-Rays, CT Scans, and MRIs? X-Rays are a form of electromagnetic radiation, like light. They are less energetic than gamma rays, and more energetic than ultraviolet light. Because they pass easily through soft tissue, like organs and muscles, but not so easily through hard tissue like bones and teeth, we are most familiar with them being used to look at skeletal structures. Sometimes a person ingests or has injected an X-ray opaque fluid that will fill a space of interest for X-ray imaging. This is called an angiogram. A nuclear scan uses an injected gamma ray emitting substance that accumulates in the organ of interest and a special camera records the gamma rays. A CT Scan is usually a series of X-rays taken from different directions that are then assembled into a three dimensional model of the subject in a computer. CT stands for computed tomography, and tomography means a picture of a slice. Where an X-ray may show edges of soft tissues all stacked on top of each other, the computer in a CT scan can figure out how those edges relate to each other in depth, and so the image has much more soft tissue usability. Another kind of CT scan uses positrons. I have to mention this because positrons are antimatter electrons (Yes, antimatter does exist and it is useful!) In Positon Emission Tomography (PET) a positron emitting radionuclide (radioactive material) is attached to a metabolically useful molecule. This is introduced to the tissue, and as emitted positrons decompose they emit gamma rays which can be traced by the machine and computer back to their points of origin, and an image is formed.
    [Show full text]
  • Mechanisms of Radiopharmaceutical Localization
    .::VOLUME 16, LESSON 4::. Mechanisms of Radiopharmaceutical Localization Continuing Education for Nuclear Pharmacists And Nuclear Medicine Professionals By James A. Ponto, MS, RPh, BCNP Chief Nuclear Pharmacists, University of Iowa Hospitals and Clinics and Professor (Clinical), University of Iowa Hospitals and Clinics The University of New Mexico Health Sciences Center, College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Program No. 0039-000-12-164- H04-P 2.5 Contact Hours or .25 CEUs. Initial release date: 7/19/2012 -- Intentionally left blank -- Mechanisms of Radiopharmaceutical Localization By James A. Ponto, MS, RPh, BCNP Editor, CENP Jeffrey Norenberg, MS, PharmD, BCNP, FASHP, FAPhA UNM College of Pharmacy Editorial Board Stephen Dragotakes, RPh, BCNP, FAPhA Michael Mosley, RPh, BCNP Neil Petry, RPh, MS, BCNP, FAPhA James Ponto, MS, RPh, BCNP, FAPhA Tim Quinton, PharmD, BCNP, FAPhA S. Duann Vanderslice, RPh, BCNP, FAPhA John Yuen, PharmD, BCNP Advisory Board Dave Engstrom, PharmD, BCNP Vivian Loveless, PharmD, BCNP, FAPhA Brigette Nelson, MS, PharmD, BCNP Brantley Strickland, BCNP Susan Lardner, BCNP Christine Brown, BCNP Director, CENP Administrator, CE & Web Publisher Kristina Wittstrom, MS, RPh, BCNP, FAPhA Christina Muñoz, M.A. UNM College of Pharmacy UNM College of Pharmacy While the advice and information in this publication are believed to be true and accurate at the time of press, the author(s), editors, or the publisher cannot accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, expressed or implied, with respect to the material contained herein.
    [Show full text]
  • Radiopharmaceuticals As Therapeutic Agents in Medical Care and Treatment
    FEATURES Radiopharmaceuticals as therapeutic agents in medical care and treatment A new IAEA research programme assists countries interested in the use of improved radiopharmaceuticals for medical therapy by Hernan l adiation applications in medical research, healthy cells. Over the past several years, several Vera-Ruiz care, and treatment today are being used to help types of RPTs with special properties, including millions of patients throughout the world. compounds for labelling monoclonal antibodies, Perhaps most widely known are diagnostic have been used in animal and human clinical applications in the field of nuclear medicine, trials with promising results. which has seen significant expansion over the The modern trend in radiopharmaceutical re- past two decades. Such applications typically search for oncology is the development of RPTs employ radionuclides as tracers to aid in diag- that may be said to be tumour-seeking and nosing or studying medical conditions. lodine- tumour-specific. In therapeutic radiopharma- 131, for example, is effective in locating brain ceutical applications—unlike the case of exter- tumours, and in determining liver and thyroid nal radiation therapy where the radiation from an activity, and technetium-99m is a common agent external sealed radioactive source is focused on for imaging studies. the site to be irradiated—the product is admin- Other radiation applications are directed at istered to the patient orally or intravenously and treatment of serious disease, typically cancers. is selectively taken up or localized in the site to These include the well-known use of cobalt-60 be irradiated. Suitable agents have to be des- in cancer therapy, for example.
    [Show full text]
  • CEA-Scan Package Insert
    10C007-3 CEA-Scan® (Arcitumomab) 8/99 For the Preparation of Technetium Tc 99m Arcitumomab. Sterile, Non-Pyrogenic, Lyophilized Powder for Intravenous Use Only. DESCRIPTION CEA-Scan® is a radiodiagnostic agent consisting of a murine monoclonal antibody Fab′ fragment, Arcitumomab, formulated to be labeled with Technetium Tc 99m. The active component, Arcitumomab, is a Fab′ fragment generated from IMMU-4, a murine IgG1 monoclonal antibody produced in murine ascitic fluid supplied to Immunomedics, Inc., by Charles River Laboratories. IMMU-4 is purified from the ascitic fluid and is digested with pepsin to produce F(ab′)2 fragments and subsequently reduced to produce the 50,000-dalton Arcitumomab. Each vial contains the non-radioactive materials necessary to prepare one patient dose. CEA-Scan® is a sterile, lyophilized formulation, containing 1.25 mg of Arcitumomab and 0.29 mg stannous chloride per vial, with potassium sodium tartrate tetrahydrate, sodium acetate trihydrate, sodium chloride, acetic acid, glacial, hydrochloric acid, and sucrose. The imaging agent, Technetium Tc 99m CEA-Scan®, Technetium Tc 99m Arcitumomab, is formed by reconstitution of the contents of the CEA-Scan® vial with 30 mCi of Tc 99m sodium pertechnetate in 1 ml of Sodium Chloride for Injection, USP. The resulting solution is pH 5-7 and for intravenous use only. Following administration, the labeled antibody can be visualized by common nuclear medicine instrumentation. Physical Characteristics of Technetium Tc 99m Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.2 The principal photon that is useful for detection and imaging is listed in the following table.
    [Show full text]
  • FR H 0356 001 Finalspc.Pdf
    1. NAME OF THE MEDICINAL PRODUCT STAMICIS 1 mg kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg [Tetrakis (2-methoxyisobutyl isonitrile) copper (I)] tetrafluoroborate. The radionuclide is not part of the kit. Excipients with known effect: One ml of solution contains 4.5 mg of sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. White powder. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications This medicinal product is for diagnostic use only. This is indicated for adults. For paediatric population see section 4.2. After radiolabelling with sodium pertechnetate (99mTc) solution, the solution of technetium (99mTc) sestamibi obtained is indicated for: Myocardial perfusion scintigraphy for the detection and localisation of coronary artery disease (angina pectoris and myocardial infarction). Assessment of global ventricular function. First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion. Scintimammography for the detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate. Localisation of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands. 4.2 Posology and method of administration Posology Adults and elderly population Posology may vary depending on gamma camera characteristics and reconstruction modalities. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified. 05/2016 1 The recommended activity range for intravenous administration to an adult patient of average weight (70 kg) is for: Diagnosis of reduced coronary perfusion and myocardial infarction 400-900 MBq.
    [Show full text]