Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 18 December 2019

Indication(s)

INDICATIONS AND USAGE Indium In-111 pentetreotide is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.

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Advisory information

contraindications
CONTRAINDICATIONS None known.
Special warnings and precautions
PRECAUTIONS General Therapy with octreotide acetate can produce severe hypoglycemia in patients with insulinomas. Since pentetreotide is an analog of octreotide, an intravenous line is recommended in any patient suspected of having an insulinoma. An intravenous solution containing glucose should be administered just before and during administration of indium In-111 pentetreotide. 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. Since indium In-111 pentetreotide is eliminated primarily by renal excretion, use in patients with impaired renal function should be carefully considered. 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 administration of this drug. In addition, it is recommended that patients be given a mild laxative (e.g., bisacodyl or lactulose) before and after administration of indium In-111 pentetreotide (see DOSAGE AND ADMINISTRATION section). 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. Components of the kit are sterile and nonpyrogenic. 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. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with indium In-111 pentetreotide to evaluate carcinogenic potential or effects on fertility. Pentetreotide was evaluated for mutagenic potential in an in vitro mouse lymphoma forward mutation assay and an in vivo mouse micronucleus assay; evidence of mutagenicity was not found. Pregnancy Category C Animal reproduction studies have not been conducted with indium In-111 pentetreotide. It is not known whether indium In-111 pentetreotide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, indium In-111 pentetreotide should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when indium In-111 pentetreotide is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Adverse reactions
ADVERSE REACTIONS The following adverse effects were observed in clinical trials at a frequency of less than 1% of 538 patients: dizziness, fever, flush, headache, hypotension, changes in liver enzymes, joint pain, nausea, sweating, and weakness. These adverse effects were transient. Also in clinical trials, there was one reported case of bradycardia and one case of decreased hematocrit and hemoglobin. 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. The following adverse reactions have been associated with octreotide in 3% to 10% of patients: 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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. Radiation Dosimetry The estimated radiation dosesValues listed include a correction for a maximum of 0.1% indium In-114m radiocontaminant at calibration.to the average adult (70 kg) from intravenous administration of 111 MBq (3 mCi) and 222 MBq (6 mCi) are presented in Table 4. These estimates were calculated by Oak Ridge Associated Universities using the data published by Krenning, et al.E.P. Krenning, W.H. Bakker, P.P.M. Kooij, W.A.P. Breeman, H.Y. Oei, M. de Jong, J.C. Reubi, T.J. Visser, C. Bruns, D.J. Kwekkeboom, A.E.M. Reijs, P.M. van Hagen, J.W. Koper, and S.W.J. Lamberts, “Somatostatin Receptor Scintigraphy with Indium-111-DTPA-D-Phe-1-Octreotide in Man: Metabolism, Dosimetry and Comparison with Iodine-123-Try-3-Octreotide,” The Journal of Nuclear Medicine, Vol. 33, No. 5, May 1992, pp. 652-658. Table 4. Estimated Absorbed Radiation Doses after Intravenous Administration of Indium In-111 PentetreotideAssumes 4.8 hour voiding interval and International Commission on Radiological Protection (ICRP) 30 model for the gastrointestinal tract calculations.to a 70 kg Patient PLANAR SPECT Organ mGy/111 MBq rads/3 mCi mGy/222 MBq rads/6 mCi Kidneys 54.16 5.42 108.32 10.83 Liver 12.15 1.22 24.31 2.43 Spleen 73.86 7.39 147.73 14.77 Uterus 6.34 0.63 12.67 1.27 Ovaries 4.89 0.49 9.79 0.98 Testes 2.90 0.29 5.80 0.58 Red Marrow 3.46 0.35 6.91 0.69 Urinary Bladder Wall 30.24 3.02 60.48 6.05 GI Tract Stomach Wall 5.67 0.57 11.34 1.13 Small Intestine 4.78 0.48 9.56 0.96 Upper Large Intestine 5.80 0.58 11.59 1.16 Lower Large Intestine 7.73 0.77 15.46 1.55 Adrenals 7.55 0.76 15.11 1.51 Thyroid 7.43 0.74 14.86 1.49 mSv/111 MBq rem/3 mCi mSv/222 MBq rem/6 mCi Effective DoseEstimated according to ICRP Publication 53.Equivalent 13.03 1.30 26.06 2.61
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when indium In-111 pentetreotide is administered to a nursing woman.

More information

Category Value
Authorisation number NDA020314
Orphan designation No
Product NDC 69945-050
Date Last Revised 28-12-2018
Type HUMAN PRESCRIPTION DRUG
Storage and handling Storage The Octreoscan kit should be stored refrigerated at 2° to 8°C (36° to 46°F). After reconstitution, store at or below 25°C (77°F). Indium In-111 pentetreotide must be used within six hours of preparation.
Marketing authorisation holder Curium US LLC