Somatuline Autogel Lanreotide Acetate Sustained-release Injection

1. Indications and Usage
Acromegaly: Indicated for the treatment of acromegaly in patients who have had insufficient response to or cannot be treated with surgery and/or radiotherapy.
Neuroendocrine Tumors: Indicated for the treatment of patients with locally advanced or metastatic, well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) and midgut carcinoid tumors.
2. Dosage and Administration
Acromegaly: The recommended initial dosage is 90 mg administered by deep subcutaneous injection once every 4 weeks for the first 3 months. Based on clinical response, serum growth hormone (GH), and insulin-like growth factor-1 (IGF-1) levels, the dosage may be increased to 120 mg every 4 weeks. If GH ≤1 ng/mL and IGF-1 are within normal limits, the dose may be reduced to 60 mg every 4 weeks.
Neuroendocrine Tumors: The recommended dosage is 120 mg administered by deep subcutaneous injection once every 28 days.
Administration: The injection should be administered by a healthcare professional into the outer upper quadrant of the buttock. The injection site should be alternated between the left and right buttocks. The pre-filled syringe should be allowed to reach room temperature (approximately 30 minutes) prior to administration.
3. Mechanism of Action
Lanreotide acetate is an analog of natural somatostatin. It binds with high affinity to somatostatin receptors (primarily subtypes 2 and 5) on the surface of pituitary and neuroendocrine tumor cells. This binding inhibits the secretion of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in acromegaly, and suppresses the release of various gut hormones, thereby slowing tumor progression and alleviating symptoms in neuroendocrine tumors.
4. Safety and Warnings
Cholelithiasis and Cholecystitis: Lanreotide decreases gallbladder motility, which may lead to the formation of gallstones. Biliary ultrasound is recommended prior to initiation and periodically during treatment.
Cardiac Disorders: Bradycardia and sinus pauses have been reported. Caution is advised when used in conjunction with other drugs that slow the heart rate (e.g., beta-blockers, calcium channel blockers).
Hyperglycemia/Hypoglycemia: Lanreotide may alter glucose metabolism. Diabetic patients require careful monitoring of blood glucose, and antidiabetic medication doses may need adjustment.
Pancreatitis: Pancreatitis has been reported; however, a causal relationship has not been established.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequently reported adverse reactions include gastrointestinal disorders (diarrhea, abdominal pain, nausea), gallbladder disorders (cholelithiasis), injection site reactions (pain, nodules), and headache.
Clinical Research: Clinical trials have demonstrated that lanreotide acetate effectively normalizes IGF-1 levels and reduces tumor volume in patients with acromegaly and neuroendocrine tumors, providing long-term symptom control with a favorable safety profile.
6. Drug Interactions
Cyclosporine: Lanreotide may decrease the intestinal absorption of orally administered cyclosporine. Blood concentration monitoring and dose adjustment of cyclosporine may be necessary.
Antidiabetic Agents: As mentioned in safety warnings, concomitant use with insulin or oral hypoglycemic agents requires close glycemic monitoring and potential dose adjustments.
Beta-Blockers: Concomitant use may have an additive effect on heart rate reduction.
7. Pharmaceutical Information
Composition: The active ingredient is lanreotide acetate. The suspension contains water for injections and acetic acid.
Appearance: The suspension is white to pale yellow.
Storage: Store in a refrigerator at 2°C to 8°C. Keep in the original packaging to protect from light. If stored in the sealed foil pouch, it may be kept at temperatures up to 40°C for a cumulative period not exceeding 24 hours.