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 adult patients 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. Lactation.
Special Precautions
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
GI disorders eg, diarrhoea, loose stools, abdominal pain; cholelithiasis; inj site pain, nodule & induration. 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 mass & pruritus; increased ALAT, glycosylated Hb, blood bilirubin & glucose, abnormal ASAT & ALAT, decreased wt & pancreatic enzymes.
Drug Interactions
Decreased blood levels of cyclosporin. 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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