Somatuline

Somatuline

lanreotide

Manufacturer:

Ipsen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Lanreotide
Indications/Uses
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.
Dosage/Direction for Use
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.
Contraindications
Hypersensitivity to lanreotide, somatostatin or related peptides.
Special Precautions
May reduce gallbladder motility & lead to gallstone formation. 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. Perform thyroid function tests if clinically indicated. Monitor vol of the 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. Dizziness may affect ability to drive & use machines. Avoid use during pregnancy. Not to be used during breast-feeding. Not recommended in childn & adolescents.
Adverse Reactions
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.
Drug Interactions
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 the 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).
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01CB03 - lanreotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.
Presentation/Packing
Form
Somatuline PR soln for inj 120 mg
Packing/Price
0.5 mL x 1's
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