Lanreotide

SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. the treatment of adults with carcinoid syndrome, when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Lanreotide, the active component of SOMATULINE DEPOT is an octapeptide analog of natural somatostatin. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin.

Administration: For deep subcutaneous injection only. Intended for administration by a healthcare provider. Administer in the superior external quadrant of the buttock. Alternate injection sites. Recommended Dosage. Acromegaly: 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen. GEP-NETs: 120 mg every 4 weeks. Carcinoid Syndrome: 120 mg every 4 weeks. If patients are already being treated with SOMATULINE DEPOT for GEP-NET, do not administer an additional dose for carcinoid syndrome. Dosage Adjustment: See full prescribing information for dosage adjustment in patients with acromegaly and renal or hepatic impairment.

SOMATULINE DEPOT is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide. Hypersensitivity to lanreotide.

Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Gallstones may occur, consider periodic monitoring. Hyperglycemia and Hypoglycemia: Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly. Cardiovascular Abnormalities: Decrease in heart rate may occur. Use with caution in at-risk patients. Thyroid Function Abnormalities: Decreases in thyroid function may occur, perform tests where clinically indicated. Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency.

The following adverse reactions to SOMATULINE DEPOT are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis Hyperglycemia and Hypoglycemia Cardiovascular Abnormalities Thyroid Function Abnormalities Steatorrhea and Malabsorption of Dietary Fats Most common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions. GEP-NET (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. Carcinoid Syndrome: (≥5% and at least 5% greater than placebo): headache, dizziness and muscle spasm.

Cyclosporine: SOMATULINE DEPOT may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed. Bromocriptine: SOMATULINE DEPOT may increase the absorption of bromocriptine. Bradycardia-Inducing Drugs (e.g., beta-blockers): SOMATULINE DEPOT may decrease heart rate. Dosage adjustment of the coadministered drug may be necessary.

Store SOMATULINE DEPOT in the refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the original package.