Somatuline

Long-term treatment of individuals w/ acromegaly when the circulating levels of growth hormone &/or insulin-like growth factor-1 remain abnormal after surgery &/or RT or in patients who require medical treatment. Symptomatic relief associated w/ acromegaly; symptomatic reduction associated w/ carcinoid syndrome. Grade 1 & a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients w/ unresectable locally advanced or metastatic disease.

SC Individualised dose. Acromegaly & carcinoid tumours Recommended starting dose: 60-120 mg deep inj every 28 days. GEP-NETs Recommended dose: 120 mg deep inj every 28 days.

Hypersensitivity to lanreotide, somatostatin or related peptides.

May reduce gallbladder motility & lead to gallstone formation; periodically monitor patients. Perform gallbladder echography before treatment & every 6 mth during prolonged treatment. Discontinue use if cholelithiasis complications (eg, cholecystitis, cholangitis & pancreatitis) are suspected. Possible hypo- or hyperglycaemia. Monitor blood glucose levels when treatment is initiated or when the dose is altered; adjust any antidiabetic treatment accordingly. Perform thyroid function tests if clinically indicated. Monitor vol of pituitary tumour. May lead to decreased heart rate w/o necessarily reaching bradycardia threshold in patients w/o underlying cardiac problems. Sinus bradycardia may occur in patients suffering from pre-existing cardiac disorders. Patients w/ bradycardia. Possible pancreatic exocrine insufficiency (PEI) in patients receiving therapy for GEP-NETs; PEI symptoms include steatorrhea, loose stools, abdominal bloating & wt loss. Consider screening & appropriate treatment for PEI in symptomatic patients. Possible dizziness may affect ability to drive & use machines. Avoid use during pregnancy. Not to be used during breast-feeding. Not recommended in childn & adolescents.

Diarrhoea, loose stools, abdominal pain; cholelithiasis. Hypoglycaemia, decreased appetite, hyperglycaemia, DM; dizziness, headache, lethargy; sinus bradycardia; nausea, vomiting, constipation, flatulence, abdominal distension & discomfort, dyspepsia, steatorrhoea; biliary dilatation; musculoskeletal pain, myalgia; alopecia, hypotrichosis; asthenia, fatigue, inj site reactions (pain, mass, induration, nodule, pruritus); increased ALT, glycosylated Hb, blood bilirubin & glucose, abnormal AST & ALT, decreased wt & pancreatic enzymes.

May decrease relative bioavailability of ciclosporin. Risk of hypo- or hyperglycaemia w/ insulin, glitazones, repaglinide & sulphonylureas. May increase availability of bromocriptine when used concomitantly w/ somatostatin analogues. May have an additive effect on slight reduction of heart rate w/ bradycardia-inducing drugs (eg, β-blockers). May decrease metabolic clearance of compd known to be metabolised by CYP450 enzymes. Concomitant use w/ other drugs mainly metabolized by CYP3A4 & which have a low therapeutic index (eg, quinidine).

Trophic Hormones & Related Synthetic Drugs

H01CB03 - lanreotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.

POM