Abbreviations: NH 3, N-13 ammonia Normal Biodistribution

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1 Radiopharmaceutical Name Radiopharmaceutical Image Normal 13 NH3 Stress / Rest 13 NH 3, 13 N-ammonia, [ 13 N]NH 3 Abbreviations: NH 3, N-13 ammonia Normal Biodistribution Radiopharmaceutical Structure The circulation mean transit time of 13 N ammonia from the circulation is 1.08 minutes, of the administered activity returns to the circulation as metabolites with a half-time of approximately 2 minutes. Approximately, 7.1% and 6.9% are taken up in liver and brain, respectively. Approximately 6.4% enters the urinary bladder with a half-time of 8 minutes. (ICRP Publication 53,1994) image courtesy of James. H Caldwell, MD University of Washington Radionuclide Emission 13 N Half-life minutes Emission positron: Emax MeV MICAD pdf/ammonian13.pdf Developed by the SNMMI PET Center of Excellence and the Center for Molecular Imaging Innovation & Translation December

2 Molecular Formula and Weight 13 NH g atom mole -1 General Tracer Class Target Molecular Process Imaged Mechanism for in vivo retention Clinical Diagnostic PET Radiopharmaceutical In vivo, 13 NH 3 is in the form of ammonium ion. After IV injection it is extracted from the capillaries through the ammonia transporter. Once in cells, it is converted to glutamine and can diffuse out of the cell or be metabolized to glutamate and retained within the cell. Targets all viable tissue that has blood flow but the clinical target is myocardial perfusion. (References: Khademi et al. 2004, Adeva et al. 2012, Feinstein Institute for Medical Research, Highlights of Prescribing Information for Ammonia 13 N Injection for intravenous use 2011) Blood vessel perfusion of tissues in general proportional to blood flow. Enters cell via the ammonium transporter with accumulation in tissue in proportion to blood perfusion of the tissue. Retention is due to the ammonium conversion to glutamate or other metabolites (References: Khademi et al. 2004, Adeva et al. 2012, Feinstein Institute for Medical Research, Highlights of Prescribing Information for Ammonia 13 N Injection for intravenous use 2011) Metabolism 13 N-ammonia undergoes a five-enzyme step metabolism in the liver to yield 13 N-urea, the main circulating metabolite. It is also metabolized to 13 N-glutamine, the main metabolite in tissues, by glutamine synthase in the skeletal muscles, liver, brain, myocardium, and other organs. Other metabolites of 13 N-ammonia include small amounts of 13 N-amino acid anions (acidic amino acids) in the forms of 13 N-glutamate or 13 N-aspartate. 13 N- ammonia is eliminated from the body by urinary excretion mainly as 13 N-urea. (Feinstein Institute for Medical Research, Highlights of Prescribing Information for 13 N-ammonia Injection for intravenous use 2011). With exercise, some ammonia may be released from skeletal muscle to the vessels (Adeva 2012) Radiosynthesis Availability Most sites use a synthesis method reported by Berridge (1993) in which water containing a small amount of ethanol is irradiated with protons in a nuclear reaction followed by a radiation chemistry process to form the 13 NH 4 + (ammonium ion) in the target. Additional information available at Molecular Imaging and Contrast Agent Database (MICAD), Bethesda (MD): National Center for Biotechnology Information pdf/ammonian13.pdf for, author Cheng. The short half-life of 13 N requires a nearby cyclotron. As for any PET radiopharmaceutical, an IND, NDA or Developed by the SNMMI PET Center of Excellence and the Center for Molecular Imaging Innovation & Translation December

3 ANDA filed with the Food and Drug Administration (FDA) is required for human use.* Status with USP / EuPh Recommended Activity and Allowable mass Dosimetry Pharmacology and Toxicology The radiopharmaceutical is approved by the FDA, and is listed in USP and EuPh. DOSAGE AND ADMINISTRATION (taken from Prescribing Information) IV administration, typically mci ( MBq) as a bolus (Feinstein Institute for Medical Research, Highlights of Prescribing Information for Ammonia 13 N Injection for intravenous use 2011) The effective dose equivalent (whole body) is estimated to be msv/mbq (10 mrem/mci) for adults. The critical organs are the kidneys, which receive mgy/mbq (17 mrad/mci) for adults (ICRP Publication No ). Additional radiation absorbed dose information is provided in the ICRP publication and in the Feinstein Institute for Medical Research, Highlights of Prescribing Information for Ammonia 13 N Injection for intravenous use.). Following intravenous injection, 13 N-ammonia is cleared rapidly from the blood with a biologic half-life of about 2.84 minutes (effective half-life of about 2.2 minutes). In the myocardium, its biologic half-life has been estimated to be less than 2 minutes (effective half-life less than 1.67 minutes). In the brain its biologic half-life is less than 3 seconds. The mass of 13 N-ammonia injected for imaging is very small compared to the normal range of ammonia in the blood ( mg) in a 70 kg healthy adult man. Reference: Feinstein Institute for Medical Research, Highlights of Prescribing Information for Ammonia 13 N Injection for intravenous use. Current Clinical Trials The NIH clinical trials registry (www.clinicaltrials.gov) should be consulted for a list of current trials using 13 N- ammonia. As of December 2012, three clinical trials were listed for the United States, only one that was still accruing patients. Reference Site / Person The best reference at this time for the state of 13 NH 3 trials is clinical trials.gov Imaging Protocol The imaging protocol for 13 N-ammonia can vary. A typical example is: Rest Imaging Study : Administer mci ( MBq) as a bolus through a catheter inserted into a large peripheral vein. Start imaging 3 minutes after the injection and acquire images for a total of minutes. Stress Imaging Study: If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first 13 N- ammonia injection to allow sufficient isotope decay. Administer a pharmacologic stress-inducing drug in accordance with its labeling. Administer mci ( MBq) of 13 N-ammonia as a bolus at peak stress (exact time point may vary depending on stress agent, for instance at 7 min when dipyridamole as stress agent is given over 4 min IV, i.e. 3 Developed by the SNMMI PET Center of Excellence and the Center for Molecular Imaging Innovation & Translation December

4 min after the completion of dipyridamole). Start imaging 3 minutes after the injection of 13 N-ammonia and acquire images for a total of minutes. Reference: Feinstein Institute for Medical Research, Highlights of Prescribing Information for Ammonia 13 N Injection for intravenous use. Human Imaging Experience Recent work indicates that dynamic imaging provides added useful clinical data because the time activity curves can be analyzed to quantify myocardial blood flow, and provide information on myocardial flow reserve in addition to the semi-quantitative results of static perfusion image analysis. (Alesssio 2012, Beller 2012, Fiechter 2012, Herzog 2009, Murthy 2012a /b, Saraste 2012). IND is an investigational new drug application, NDA is new drug application, ANDA is an amended new drug application. Listed below are selected references for 13 N-ammonia injection. Because this is a drug that is administered primarily as a clinical drug under NDA with the FDA, the principle reference that is provided is the prescribing information available on the FDA website. Adeva MM et al. Ammonium Metabolism in Humans. Metabolism 2012; 61: Alessio AM et al. Validation of an axially distributed model for quantification of myocardial blood flow using 13 N-ammonia PET. J Nucl Cardiol 2013; 20: Beller G. Quantification of myocardial blood flow with PET: Ready for clinical application. Editorial. J Nucl Cardiol 2012; 19: Berridge MS et al. In-target Production of [ 13 N]Ammonia: Target Design, Products and Operating Parameters. Appl Radiat Isot 1993; 44 (12) Cheng, KT. [ 13 N]Ammonia. Molecular Imaging and Contrast Agent Database (MICAD), Bethesda (MD): National Center for Biotechnology Information pdf/ammonian13.pdf Feinstein Institute for Medical Research (Chaly T). Highlights of Prescribing Information for Ammonia N 13 Injection for intravenous Use. 2011, Initial approval Developed by the SNMMI PET Center of Excellence and the Center for Molecular Imaging Innovation & Translation December

5 SNMMI would like to acknowledge Jeanne Link, PhD for her contributions to developing this content. Fiecter M. Diagnostic Value of 13 N-Ammonia Myocardial Perfusion PET: Added Value of Myocardial Flow Reserve. J Nucl Med 2012; 53: Herzog, BA et al. Long-Term Prognostic Value of 13 N-Ammonia for Myocardial Perfusion Positron Emission Tomography. JACC 2009; 54: International Commission on Radiological Protection (ICRP) Task Group Committees 2 and 3. Radiation Dose to Patients from Radiopharmaceuticals. ICRP Publication 53 and Addendum 1. Pages Pergamon Press. New York, NY (Also referenced as ICRP Vol 18 (1-4)) Khademi S et al. Mechanism of Ammonia Transport by Amt/MEP/Rh: Structure of AmtB at 1.35 Å. Science 2004; 305: Murthy VL et al. Association between Coronary Vascular Dysfunction and Cardiac Mortality in Patients with and without Diabetes Mellitus. Circulation 2012a; 121: Murthy VL et al. Non-invasive quantification of coronary vascular dysfunction for diagnosis and management of coronary artery disease. J Nucl Cardiol 2012; 19: Saraste A. PET: Is myocardial flow quantification a clinical reality? J Nucl Cardiol 2012; 19: Developed by the SNMMI PET Center of Excellence and the Center for Molecular Imaging Innovation & Translation December

voiding as soon as each image acquisition is completed and as often as possible thereafter for at least one hour.

voiding as soon as each image acquisition is completed and as often as possible thereafter for at least one hour. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13

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