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Octreoscan™

Kit for the Preparation of Indium In-111 Pentetreotide

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.

How Supplied

Distribution Direct
Calibration Day As assigned
Expiration Reconstituted kit: should be used within 6 hours of reconstitution
Shelf Life Kit expiration is 1 day after calibration of the In-111 placed in the kit.
Storage Conditions Kit should be stored refrigerated at 2°C to 8°C (36°F to 46°F). After reconstitution, store at or below 25°C (77°F).

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Kit, single vial pentetreotide & single vial In-111 1 each 10 mL N050D0 00019905040

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What is the shelf life for the Octreoscan imaging agent kit? One day past calibration of the In-111 in the kit
What is the half life? The half-life of In-111 is 2.805 days.
What is the expiration for the reconstituted vial of Octreoscan imaging agent? The expiration in 6 hours after reconstitution.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.