Octreotide

Sandostatin Injection is a somatostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1, somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.

Sandostatin Injection exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, VIP, secretin, motilin, and pancreatic polypeptide. By virtue of these pharmacological actions, octreotide has been used to treat the symptoms associated with metastatic carcinoid tumors (flushing and diarrhea), and VIP secreting adenomas (watery diarrhea).

Sandostatin Injection may be administered subcutaneously or intravenously. Acromegaly: Recommended initial Sandostatin dosage is 50 mcg three times daily during the initial 2 weeks of therapy. Maintenance dose 100 mcg to 500 mcg three times daily. Carcinoid Tumors: Recommended dosage range of 100 mcg to 600 mcg daily in two to four divided doses during the initial 2 weeks of therapy. VIPomas: Recommended dosage range of 200 mcg to 300 mcg daily in two to four divided doses during the initial 2 weeks of therapy.

Sensitivity to this drug or any of its components.

Cardiac Function Abnormalities: Increased risk for higher degree of atrioventricular blocks. Consider cardiac monitoring in patients receiving Sandostatin Injection intravenously. Bradycardia, arrhythmias, or conduction abnormalities may occur. Use with caution in at-risk patients. Dosage adjustment of cardiac medications may be necessary. Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and anti-diabetic treatment may need adjustment. Thyroid Function: Hypothyroidism may occur. Monitor thyroid levels periodically. Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur.

The following clinically significant adverse reactions are described elsewhere in the labeling: Complete Atrioventricular Block Cholelithiasis and Complications of Cholelithiasis Hyperglycemia and Hypoglycemia Thyroid Function Abnormalities Steatorrhea and Malabsorption of Dietary Fats Changes in Vitamin B12 Levels Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism. In other patients, most common adverse reactions (incidence > 10%) are gallbladder abnormalities.

The following drugs require monitoring and possible dose adjustment when used with Sandostatin Injection: Cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. Lutetium Lu 177 Dotatate Injection: Discontinue Sandostatin Injection at least 24 hours prior to each lutetium Lu 177 dotatate dose.

For prolonged storage, Sandostatin ampuls should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and store in outer carton in order to protect from light. At room temperature (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration.