Pentetreotide

• Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.

• None known.contraindicated

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 mCi) of Indium In 111 Pentetreotide Injection prepared from an Octreoscan kit. The recommended intravenous dose for SPECT imaging is 222 MBq (6 mCi) of Indium In 111 Pentetreotide Injection. 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.

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 Injection and to monitoring the patient for any signs of withdrawal. Hypersensitivity reactions following administration of somatostatin receptor imaging agents predominantly consisted of cutaneous reactions such as rash and pruritus. Reactions reversed either spontaneously or with routine symptomatic management. Less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis.

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 Injection 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. The following adverse reactions have been identified during postapproval use of Octreoscan. Because 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, predominantly rash, pruritus, less frequently angioedema or features of anaphylaxis.

Pregnancy 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 Injection should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Metabolism

Radioactivity leaves the plasma rapidly; one third of the radioactive injected dose remains in the blood pool at 10 minutes after administration. Plasma levels continue to decline so that by 20 hours post-injection, about 1% of the radioactive dose is found in the blood pool.

• Jun 2, 1994NDANDA020314Curium
• Jul 1, 2024ANDAANDA212785Sun Pharm Inds Inc

1. 1Intentional Drug Misuse3124%
2. 2Death2116%
3. 3Haemoglobin Abnormal1613%
4. 4Nausea1512%
5. 5Drug Ineffective1411%
6. 6Platelet Disorder107.8%
7. 7Product Use Issue107.8%
8. 8Disease Progression86.3%
9. 9Product Use In Unapproved Indication86.3%
10. 10Blood Bilirubin Abnormal75.5%
11. 11Haematotoxicity75.5%
12. 12Pyrexia75.5%
13. 13Diarrhoea64.7%
14. 14Flushing64.7%
15. 15Malignant Neoplasm Progression64.7%

The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Pentetreotide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
  Completed · Interventional · 169 enrolled · Radio Isotope Therapy of America
  NCT01879657updated 2025-08-06
• Asymptomatic Small Pancreatic Endocrine Neoplasms.
  Unknown · Observational · 1,000 enrolled · IRCCS San Raffaele
  NCT03084770updated 2024-01-18
• Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
  Completed · Phase 2 · Phase 3 · Interventional · 200 enrolled · Radio Isotope Therapy of America
  NCT00442533updated 2023-04-03
• Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
  Completed · Phase 2 · Interventional · 68 enrolled · Sue O'Dorisio
  NCT01869725updated 2021-09-22
• Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors
  Completed · Phase 1 · Phase 2 · Interventional · 223 enrolled · Sue O'Dorisio
  NCT01619865updated 2021-07-27
• New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
  Completed · Phase 2 · Interventional · 95 enrolled · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  NCT00001849updated 2021-04-14
• Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
  Completed · Interventional · 17 enrolled · Marcelo F. Di Carli, MD, FACC
  NCT02546388updated 2020-04-09
• Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor
  Terminated · Phase 3 · Interventional · 4 enrolled · GERCOR - Multidisciplinary Oncology Cooperative Group
  NCT02465112updated 2019-02-28
• Volumetric Imaging Follow up of Patients With Liver Metastases of Small Intestinal Neuroendocrine Tumors (NETs).
  Unknown · Observational · 80 enrolled · Hospices Civils de Lyon
  NCT03689231updated 2018-09-28
• Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors
  Terminated · Phase 4 · Interventional · 150 enrolled · Mallinckrodt
  NCT00944372updated 2016-09-09

Frequently asked questions

What is Pentetreotide used for?

According to FDA labeling, Pentetreotide carries indications including: Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Pentetreotide?

Pentetreotide labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.