Somatuline Special Precautions

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore, patients may need to be monitored periodically. It is advised, during prolonged treatment, to perform before treatment and every 6 months, an echography of the gallbladder. There have been postmarketing reports of gallstones resulting in complications, including cholecystitis, cholangitis, and pancreatitis, requiring cholecystectomy in patients taking lanreotide. If complications of cholelithiasis are suspected, discontinue lanreotide and treat appropriately.
Pharmacological studies in animals and humans showed that lanreotide, like somatostatin and other somatostatin analogues, inhibits secretion of insulin and glucagon. Hence, patients treated with lanreotide may experience hypoglycaemia or hyperglycaemia. Blood glucose levels should be monitored when lanreotide treatment is initiated, or when the dose is altered. Any antidiabetic treatment should be adjusted accordingly.
Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, though clinical hypothyroidism is rare. Thyroid function tests are recommended where clinically indicated.
In acromegalic patients and patients presenting with primitive thyrotropic adenoma, use of lanreotide is not exempt from the monitoring of the volume of the pituitary tumour.
In patients without underlying cardiac problems, lanreotide may lead to a decrease of heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from pre-existing cardiac disorders, sinus bradycardia may occur.
Care should be taken when initiating treatment with lanreotide in patients with bradycardia.
Pancreatic function: Pancreatic exocrine insufficiency (PEI) has been observed in some patients receiving lanreotide therapy for gastroenteropancreatic neuroendocrine tumours. Symptoms of PEI can include steatorrhea, loose stools, abdominal bloating and weight loss. Screening and appropriate treatment for PEI according to clinical guidelines should be considered in symptomatic patients.
Effects on ability to drive and use machines: Somatuline Autogel has minor or moderate influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.
However, dizziness has been reported with Somatuline Autogel (see Adverse Reactions). If a patient is affected, he/she should not drive or operate machinery.