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 (octreotide acetate) for injectable suspension. 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. Anti-diabetic 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 electrocardiogram 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 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.

Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate. Discontinue Sandostatin LAR Depot at least 4 weeks prior to each lutetium Lu 177 dotatate dose.

Adverse Reactions

The most common adverse reactions occurring in patients receiving Sandostatin LAR Depot are 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%).