Somatuline Autogel

Somatuline Autogel

lanreotide

Manufacturer:

Ipsen Pharma

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Lanreotide
Indications/Uses
Acromegaly when secretions of growth hormone & insulin-like growth factor-1 remain abnormal after surgery &/or RT, clinical symptoms associated w/ acromegaly & neuroendocrine (particularly carcinoid) tumours. 120 mg: Grade 1 & 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 adults w/ unresectable locally advanced or metastatic disease.
Dosage/Direction for Use
Acromegaly & carcinoid tumours Initially 60-120 mg deep SC inj every 28 days, may be increased/decreased depending on patient's response. GEP-NETs 120 mg as single deep SC inj every 28 days continued as long as needed.
Contraindications
Hypersensitivity to lanreotide, somatostatin or related peptides.
Special Precautions
Discontinue use if cholelithiasis complications are suspected. Patients w/ bradycardia, preexisting cardiac disorders; steatorrhoea. Monitor blood glucose levels; pituitary tumour vol in patients w/ adenomas. Perform gallbladder echography prior to, during & every 6 mth of treatment; thyroid function test during therapy. May affect ability to drive & use machines. May affect female fertility. Avoid use during pregnancy. Not to be used during lactation. Childn & adolescents.
Adverse Reactions
Diarrhoea, loose stools, abdominal pain; cholelithiasis. Hypo- & hyperglycaemia, decreased appetite, 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; increased blood bilirubin & glucose, ALAT & glycosylated Hb, abnormal ASAT & ALAT, decreased wt & pancreatic enzymes.
Drug Interactions
Decreased cyclosporin blood levels. Risk of hyper- or hypoglycaemia w/ insulin, glitazones, repaglinide, sulphonylureas. Slight heart rate reduction w/ bradycardia-inducing drugs eg, β-blockers. Decreased metabolic clearance of CYP3A4-metabolized drugs & drugs w/ 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 Autogel PR soln for inj (pre-filled syringe) 120 mg
Packing/Price
0.5 mL x 1's
Form
Somatuline Autogel PR soln for inj (pre-filled syringe) 60 mg
Packing/Price
0.5 mL x 1's
Form
Somatuline Autogel PR soln for inj (pre-filled syringe) 90 mg
Packing/Price
0.5 mL x 1's
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