For the long-term treatment of patients with acromegaly who had inadequate response to or cannot be treated with surgery and/or radiotherapy
Somatuline® Depot (lanreotide) Injection is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
WARNINGS AND PRECAUTIONS
- Cholelithiasis and Gallbladder Sludge: Somatuline Depot may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed
- Hypoglycemia or Hyperglycemia: Pharmacological studies show that Somatuline Depot, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Blood glucose levels should be monitored when Somatuline Depot treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly
- Thyroid Function: Slight decreases in thyroid function have been seen in acromegalic patients during treatment, though clinical hypothyroidism is rare (<1%). Thyroid function tests are recommended where clinically indicated
- Cardiac Abnormalities: Somatuline Depot may decrease heart rate. In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension. In patients without underlying cardiac disease, Somatuline Depot may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia
- Drug Interactions: The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels
The most common adverse reactions (incidence >5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reactions (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%).
USE IN SPECIFIC POPULATIONS
Patients with moderate and severe renal impairment or moderate and severe hepatic impairment: Initial dose is 60 mg every 4 weeks.
Somatuline Depot is a somatostatin analog (SSA) indicated for the long-term treatment of patients with acromegaly who had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
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Somatuline Depot is available in 60 mg, 90, mg and 120 mg