Somatuline Autogel Special Precautions

Pharmacological studies in animals and humans show that lanreotide, like somatostatin and its analogues, inhibits secretion of insulin and glucagon. Hence patient 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 diabetic treatment should be adjusted accordingly. In insulin-treated diabetic patients, the insulin doses will initially be reduced by 25% then adapted to the blood glucose level, which must be carefully controlled in these patients when starting the treatment.
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 treatment and every 6 months, an echography of the gallbladder. There have been postmarketing reports of gallstones, including cholecystitis, cholangitis, and pancreatitis, requiring cholecystectomy in patients taking lanreotide. If complications of cholelithiasis are suspected, discontinue lanreotide and treat appropriately.
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. Caution should be taken when initiating treatment with lanreotide in patients with bradycardia.
The appearance of a significant and lasting increase of steatorrhoea justifies the complementary prescription of pancreatic extracts.
Effects on ability to drive and use machines: While no effect on the ability to drive and use machines has been established, dizziness has been reported with Somatuline Autogel. If a patient is affected, he/she should not drive or operate machinery.