Octreoscan
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Indium In 111 pentetreotide is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
History
There is currently no drug history available for this drug.
Other Information
OctreoScan™ is a kit for the preparation of indium In 111 pentetreotide, a diagnostic radiopharmaceutical. It is a kit consisting of two components:
1) A 10-mL OctreoScan Reaction Vial which contains a lyophilized mixture of:
(i) 10 μg pentetreotide [N-(diethylenetriamine-N,N,N',N”-tetraacetic acid-N”-acetyl)-D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as octreotide DTPA),
(ii) 2.0 mg gentisic acid [2, 5-dihydroxybenzoic acid],
(iii) 4.9 mg trisodium citrate, anhydrous,
(iv) 0.37 mg citric acid, anhydrous, and
(v) 10.0 mg inositol.
Pentetreotide has the following structural formula:
Prior to lyophilization, sodium hydroxide or hydrochloric acid may have been added for pH adjustment. The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.
2) A 10-mL vial of Indium In 111 Chloride Sterile Solution, which contains: 1.1 mL or 111 MBq/mL (3.0 mCi/mL) indium In 111 chloride in 0.02N HCl at time of calibration. The vial also contains ferric chloride at a concentration of 3.5 μg/mL (ferric ion, 1.2 μg/mL). The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.
Indium In 111 pentetreotide is prepared by combining the two kit components (see INSTRUCTIONS FOR THE PREPARATION OF INDIUM In 111 PENTETREOTIDE). Indium In 111 reacts with the diethylenetriaminetetraacetic acid portion of the pentetreotide molecule to form indium In 111 pentetreotide. The pH of the resultant indium In 111 pentetreotide solution is between 3.8 and 4.3. No bacteriostatic preservative is present.
The indium In 111 pentetreotide solution is suitable for intravenous administration as is, or it may be diluted to a maximum volume of 3.0 mL with 0.9% Sodium Chloride Injection, U.S.P., immediately before intravenous administration. In either case, the labeling yield of indium In 111 pentetreotide should be determined before administration to the patient. A method recommended for determining the labeling yield is presented at the end of this package insert.
Sources
Octreoscan Manufacturers
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Mallinckrodt Inc.
![Octreoscan (Indium In -111 Pentetreotide) Kit [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Octreoscan | Mallinckrodt Inc.
Before administration, a patient should be well hydrated. After administration, the patient must be encouraged to drink fluids liberally. Elimination of extra fluid intake will help reduce the radiation dose by flushing out unbound, labelled pentetreotide by glomerular filtration. It is also recommended that a mild laxative (e.g., bisacodyl or lactulose) be given to the patient starting the evening before the radioactive drug is administered, and continuing for 48 hours. Ample fluid uptake is necessary during this period as a support both to renal elimination and the bowel-cleansing process. In a patient with an insulinoma, bowel-cleansing should be undertaken only after consultation with an endocrinologist.
The recommended intravenous dose for planar imaging is 111 MBq (3.0 mCi) of indium In 111 pentetreotide prepared from an OctreoScan kit. The recommended intravenous dose for SPECT imaging is 222 MBq (6.0 mCi) of indium In 111 pentetreotide.
The dose should be confirmed by a suitably calibrated radioactivity ionization chamber immediately before administration.
As with all intravenously administered products, OctreoScan should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations.
Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves should be worn during the administration procedure.
Do not administer OctreoScan in TPN solutions or through the same intravenous line.
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