Octreoscan™

Warning and precautions

• Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides. 
• 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. 
• 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.  Therefore, 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. 
• General: 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.  They should increase fluid intake and void frequently for one day after the administration of this drug.  In addition, it is recommended that patients be given a mild laxative before and after administration of Indium In 111 pentetreotide. 
• Contamination: The following measures should be taken for up to 12 hours after receiving the radiopharmaceutical product: toilet should be used instead of urinal; toilet should be flushed several times after use and if blood or urine gets onto clothing, such clothing should be washed separately or stored for 1 to 2 weeks to allow for decay. 
• Hepatic/Biliary/Pancreatic: 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. 
  Therapy with octreotide acetate can produce severe hypoglycemia in patients with insulinomas.  Precautions should be taken to prevent hypoglycemia in these patients.
• Renal:  Since indium In-111 pentetreotide is eliminated primarily by renal excretion, use in patients with impaired renal function should be carefully considered. 
• Reproductive Health: Since adequate reproduction studies have not been performed in animals to determine whether this drug affects fertility in males or females, has teratogenic potential, or has other adverse effects on the fetus, this radiopharmaceutical preparation should not be administered to pregnant women unless it is considered that the benefits to be gained outweigh the potential hazards. 

Adverse reactions

The most frequently occurring adverse reactions are: nausea, vomiting, headache, flushing and hyperhidrosis. 

The following less common and transient adverse reactions were reported in 1% of 538 patients during clinical trials:  

• Gastrointestinal disorders: Nausea; 
• General disorders and administration site conditions: Pyrexia, Hyperhidrosis, Asthenia; 
• Investigations: Alterations in liver enzymes; 
• Musculoskeletal and connective tissue disorders: Arthralgia; 
• Nervous system disorders: Dizziness, Headache; and 
• Vascular disorders: Hypotension, Flushing. 

There was also one reported case of bradycardia and one case of decreased hematocrit and hemoglobin. 

In addition to the events listed above, the following have been identified during post-approval use of Octreoscan. Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 

Immune system disorders: Hypersensitivity reactions: Pruritus; Rash; Urticaria; and Erythema. Rare cases of head and neck edema have been described in patients exposed to Octreoscan. 

Use in specific populations

• Pregnant women: Examinations should be performed during the first ten days following the onset of the menses or after ensuring the women is not pregnant. 
• 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.
• Pediatric/geriatric: Safety and effectiveness have not been established.