for:

Severe Diarrhea and Flushing Associated With Carcinoid Syndrome

Important Safety Information

Warnings and Precautions: Gallbladder abnormalities may occur: Patients should be monitored periodically. Glucose Metabolism: Hypoglycemia or hyperglycemia may occur...

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Indication Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors and long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated. In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.

Mechanism of Action

 

PROVEN HISTORY OF SOMATOSTATIN RECEPTOR-TARGETED INHIBITION

Mechanism of Action Video

About Sandostatin LAR Depot

PROVEN HISTORY OF SOMATOSTATIN RECEPTOR-TARGETED INHIBITION

Sandostatin (octreotide acetate) is a somatostatin analogue that is effective at reducing the levels of serotonin, growth hormone, and some of the major gastrointestinal hormones released from carcinoid tumors.1,2

Inhibits hormone secretions

  • Carcinoid syndrome is caused by the endocrine and exocrine secretions of various hormones from carcinoid tumors1,3
  • The severe diarrhea associated with metastatic carcinoid tumors is related to elevated levels of serotonin and its metabolite, 5-HIAA4,5

Provides somatostatin receptor-targeted inhbition

  • Sandostatin® LAR Depot (octreotide acetate for injectable suspension) targets key somatostatin receptors and can regulate important cellular activity as well as help inhibit hypersecretion of hormones, including serotonin and growth hormone2
  • This can help lead to the control of the severe diarrhea and flushing associated with metastatic carcinoid tumors and watery diarrhea associated with VIP-secreting adenomas5

References: 1. Sandostatin LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014. 2. Susini C, Buscail L. Rationale for the use of somatostatin analogs as antitumor agents. Ann Oncol. 2006;17(12):1733-1742. 3. Rubin J, Ajani J, Schirmer W, et al. Octreotide acetate long-acting formulation versus open-label subcutaneous octreotide acetate in malignant carcinoid syndrome. J Clin Oncol. 1999;17(2):600-606. 4. Öberg K, Kvols L, Caplin M, et al. Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol. 2004;15(6):966-973. 5. Davis Z, Moertel CG, McIlrath DC. The malignant carcinoid syndrome. Surg Gynecol Obstet. 1973;137:637-644. 6. McCormick D. Carcinoid tumors and syndrome. Gastroenterol Nurs. 2002;25(3):105-111. 

IMPORTANT SAFETY INFORMATION

Warnings and Precautions:

  • Gallbladder abnormalities may occur: Patients should be monitored periodically.
  • Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be monitored when Sandostatin LAR Depot treatment is initiated or when the dose is altered. Antidiabetic treatment should be adjusted accordingly. 
  • Thyroid Function: Hypothyroidism may occur. Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) is recommended.
  • Cardiac Function: Bradycardia, arrhythmia, conduction abnormalities, and other EKG changes may occur. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac disease. Use with caution in at-risk patients.
  • Nutrition: Octreotide may alter absorption of dietary fats. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin LAR Depot. Patients on total parenteral nutrition (TPN) and octreotide should have periodic monitoring of zinc levels.  

Drug Interactions: The following drugs require monitoring and possible dose adjustment when used with Sandostatin LAR Depot: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should be used with caution. 

Adverse ReactionsThe most common adverse reactions occurring in patients receiving Sandostatin LAR Depot were biliary abnormalities (62%), injection site pain (20-50%), nausea (24-41%), abdominal pain (10-35%), fatigue (8-32%), headache (16-30%), hyperglycemia (27%), back pain (8-27%), constipation or vomiting (15-21%), dizziness (18-20%), sinus bradycardia (19%), pruritus (18%), URTI (10-18%), myalgia (4-18%), flatulence (9-16%), arthropathy (8-15%), rash (15%), generalized pain (4-15%), sinusitis (5-12%), conduction abnormalities (9%), hypoglycemia (4%), and arrhythmia (3%).

Please see full Prescribing Information.

Indications and Usage

Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated for:

  • Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
  • Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.