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  • OCTREOSCAN™

    (kit for the preparation of indium In-111 pentetreotide)

    Octreoscan imaging agent is a unique molecular imaging agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
    Full US prescribing information
  • DETECT

    LOCALIZE

    INFORM

  • DETECT
    Uniquely targeted for identification of neuroendocrine tumors bearing somatostatin receptors.1

    LOCALIZE
    Highly sensitive for a variety of primary neuroendocrine tumors and metastases.2,3

    INFORM
    Provides valuable clinical information to support the diagnosis and selection of a treatment plan.4,5

    TUMOR TYPE SENSITIVITY (Patient Incidence)
    Carcinoid 89% (117/132)
    Gastrinoma 100% (25/25)
    Glucagonoma 100% (6/6)
    VIPoma 100% (4/4)
    Insulinoma 42% (5/12)
    Medullary Thyroid Carcinoma 67% (12/18)
    Pheochromocytoma 86% (6/7)
    Pituitary Adenoma 71% (24/34)
    Small Cell Lung Carcinoma 100% (2/2)
    Paraganglioma 100% (3/3)
    * Data from Clinical trials on file at Mallinckrodt.
    "After more than a decade of experience, somatostatin receptor scintigraphy (SRS) with 111 In-DTPA octreotide (Octreoscan™ imaging agent) has become the main [radiopharmaceutical] imaging technique for neuroendocrine tumors and is used routinely."4

    INDICATIONS AND USAGE

    Octreoscan Kit for the Preparation of Indium In-111 Pentetreotide is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.


    IMPORTANT RISK INFORMATION
     
    WARNINGS AND PRECAUTIONS

    • DO NOT ADMINISTER IN TOTAL PARENTERAL NUTRITION (TPN) ADMIXTURES OR INJECT INTO TPN INTRAVENOUS ADMINISTRATION LINES; IN THESE SOLUTIONS, A COMPLEX GLYCOSYL OCTREOTIDE CONJUGATE MAY FORM.
    • The sensitivity of scintigraphy with indium In-111 pentetreotide may be reduced in patients concurrently receiving therapeutic doses of octreotide acetate. Consideration should be given to temporarily suspending octreotide acetate therapy before the administration of indium In-111 pentetreotide and to monitoring the patient for any signs of withdrawal.
    • Therapy with octreotide acetate can produce severe hypoglycemia in patients with insulinomas. Precautions should be taken to prevent hypoglycemia in these patients.
    • The contents of the two vials supplied with the kit are intended only for use in the preparation of indium In-111 pentetreotide and are NOT to be administered separately to the patient.
    • As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other persons.
    • Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
    • To help reduce the radiation dose to the thyroid, kidneys, bladder, and other target organs, patients should be well hydrated before the administration of indium In-111 pentetreotide.  It is also recommended that patients be given a mild laxative before and after administration of indium In-111 pentetreotide.
    • Indium In-111 pentetreotide should be tested for labeling yield of radioactivity prior to administration. The product must be used within six hours of preparation.
    • To maintain sterility, it is essential that directions are followed carefully. Aseptic technique must be used during the preparation and administration of indium In-111 pentetreotide.
    • Octreotide acetate and the natural somatostatin hormone may be associated with cholelithiasis, presumably by altering fat absorption and possibly by decreasing motility of the gallbladder. A single dose of indium In-111 pentetreotide is not expected to cause cholelithiasis.

    ADVERSE REACTIONS

    • Serious adverse reactions may include bradycardia and decreased hematocrit and hemoglobin (one reported case of each in clinical trials involving 538 patients).
    • Adverse effects observed at a rate less than 1% of 538 patients include dizziness, fever, flush, headache, hypotension, changes in liver enzymes, joint pain, nausea, sweating, and weakness. These adverse effects were transient.
    • False Positive/ False Negative Results:  From the clinical trials, overall, including all tumor types with or without the presence of somatostatin receptors, there were 3/508 false positives and 104/508 false negatives.
    • Pentetreotide is derived from octreotide which is used as a therapeutic agent to control symptoms from certain tumors. The usual dose for indium In-111 pentetreotide is approximately 5 to 20 times less than for octreotide and is subtherapeutic.
      • Common adverse reactions of octreotide include nausea, injection site pain, diarrhea, abdominal pain/discomfort, loose stools, and vomiting.
      • Hypertension and hyper- and hypoglycemia have also been reported with the use of octreotide.

    USE IN SPECIFIC POPULATIONS

    • Breast feeding: It is not known if this drug is excreted in human milk, caution should be exercised when indium In-111 pentetreotide is administered to a nursing woman.
    • Pediatrics: Safety and effectiveness have not been established in pediatric patients.
    • Since indium In-111, pentetreotide is eliminated primarily by renal excretion, use in patients with impaired renal function should be carefully considered.

     

    1 Octreoscan™ imaging agent package insert.
    2 Krenning E, Kwekkeboom D, Pauwels S, Kvols L, Reubi J. Somatostatin Receptor Scintigraphy. In: Freeman L, ed. Nucl Med Annual. Raven Press; 1995: 1-50.
    3 Modlin I, Kidd M, Latich I, Zikusoka M, Shapiro M. Current Status of Gastrointestinal Carcinoids. Gastroenterology. 2005; 128: 1717-1751.
    4 Rufini M, Calcagni M, Baum R. Imaging of Neuroendocrine Tumors. Sem Nucl Med. 2006; 36: 228-247.
    5 Lebtahi R, Cadiot G, Sarda L, et al. Clinical impact of somatostatin receptor scintigraphy in the management of patients with neuroendocrine gastroenteropancreatic tumors. J Nucl Med. 1997; 38: 853-858.