OCLAIZ™ (octreotide) extended-release injection is a somatostatin analog indicated for maintenance treatment of acromegaly in adults who have responded to and tolerated octreotide or lanreotide.

• Contraindications: Hypersensitivity to octreotide or any of the components of OCLAIZ. Anaphylactic shock may occur in patients receiving octreotide.
• Cholelithiasis and Complications of Cholelithiasis: Cholelithiasis and complications of cholelithiasis were observed in patients treated with OCLAIZ. In postmarketing reports with somatostatin analogs (including octreotide), complications have included cholecystitis, cholangitis, pancreatitis, and cholecystectomy. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
• Hyperglycemia and Hypoglycemia: Hyperglycemia or hypoglycemia, may occur in patients treated with octreotide. Monitor glucose and adjust antidiabetic treatment as needed.
• Thyroid Function Abnormalities: Octreotide suppresses the secretion of thyroid-stimulating hormone (TSH), which may result in hypothyroidism. Assess thyroid function at baseline and periodically.
• Cardiac Function Abnormalities: Arrhythmias, including bradycardia and tachycardia, conduction abnormalities, and other ECG changes such as QT prolongation may occur in patients with acromegaly and have been reported in patients during octreotide therapy. The relationship of these events to octreotide is not established because many of these patients have underlying cardiac disease. Drugs that have bradycardia effects may need dosage adjustments.
• Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment, including octreotide, may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported, evaluate for potential pancreatic exocrine insufficiency and manage accordingly.
• Changes in Vitamin B₁₂ Levels: Vitamin B₁₂ deficiency and abnormal Schilling tests may occur in patients receiving octreotide therapy, including OCLAIZ. Monitor vitamin B₁₂ levels during treatment.
• Most Common Adverse Reactions (≥5%): Arthralgia, headache, pruritus, abdominal pain, and back pain.
• Drug Interactions: The following drugs require monitoring and possible dose adjustment when used with OCLAIZ: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.

Please report adverse events to Camurus at 1-877-226-0005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.