For:
Severe Diarrhea and Flushing Associated With Carcinoid Syndrome
Important Safety Information

Warnings and Precautions Gallbladder abnormalities may occur. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, ...

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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

About Sandostatin LAR Depot

Sandostatin® LAR Depot (octreotide acetate) for injectable suspension has been designed to target somatostatin receptors. Octreotide exerts pharmacologic actions similar to those of the natural hormone somatostatin, but it is an even more potent inhibitor of growth hormone, glucagon, and insulin.1,2 Once it presents in the systemic circulation, octreotide distributes and exhibits a 3-phase pharmacokinetic profile.2-4

 

Complex Microsphere Technology

Sandostatin LAR Depot allows for longer dosing intervals by using a complex microsphere technology. Drug particles are encapsulated within a biodegradable microsphere polymer matrix, which slowly biodegrades in the muscle.3,4

Why Manufacturing Matters

A complex formulation requires a dedicated manufacturing facility. Significant investments in the dedicated facility and years of systematic validation and root-cause analyses have improved the manufacturing quality of Sandostatin LAR Depot.4,5 Learn more by watching the video below.

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References: 1. Susini C, Buscail L. Rationale for the use of somatostatin analogs as antitumor agents. Ann Oncol. 2006;17(12):1733-1742. 2. Sandostatin LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 3. Anthony L, Freda PU. From somatostatin to octreotide LAR: evolution of a somatostatin analogue. Curr Med Res Opin. 2009;12(12):2989-2999. 4. Petersen H, Bizec JC, Schuetz H, Delporte ML. Pharmacokinetic and technical comparison of Sandostatin® LAR® and other formulations of long-acting octreotide. BMC Res Notes. 2011;4(344):1-8. 5. Pribil A. Applied statistics— Sandostatin LAR case study. Slide presentation presented at: Manufacturing Science and Technology Technical Forum; July 6, 2016.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Gallbladder abnormalities may occur. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, pancreatitis, and requiring cholecystectomy in patients taking Sandostatin LAR Depot. Patients should be monitored periodically. If complications of cholelithiasis are suspected, discontinue Sandostatin LAR Depot and treat appropriately
  • 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 ECG 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 Reactions

  • The 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%), upper respiratory tract infection (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.