PBS Information: Authority required (STREAMLINED).
This product is a highly specialised drug listed on the PBS as a Section 100 item.
Refer to PBS Schedule for full authority information.
Somatuline® Autogel®: Lanreotide as acetate in a pre-filled syringe (60, 90 and 120 mg). Indications: Treatment of acromegaly when circulating growth hormone and IGF-1 levels remain abnormal after surgery and/or radiotherapy or in patients who have failed dopamine agonist therapy; the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours; the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease. Contraindications: Lactation; hypersensitivity to lanreotide or related peptides or other excipients. Precautions: May experience hypoglycaemia or hyperglycaemia (monitor blood glucose levels); slight decrease in thyroid function; may reduce gall bladder motility (recommend gall bladder echography); monitor kidney and liver function; may reduce heart rate in patients without an underlying cardiac problem (monitor heart rate; caution with treatment initiation in patients with bradycardia). Not recommended for use in children. See full PI for further information. Interactions with Other Medicines: Reduced absorption of cyclosporin A, decreased bioavailability of cyclosporine, increased availability of bromocriptine, additive bradycardia effects with beta-blockers, decreased clearance of quinidine, terfenadine. Effect on driving / using machinery: If affected by dizziness do not drive or use machinery. Adverse Effects: Very common: diarrhoea or loose stools, abdominal pain, cholelithiasis; Common: hypoglycaemia, hyperglycaemia, diabetes mellitus aggravated, fatigue, lethargy, asthenia, dizziness, headache, sinus bradycardia, alopecia, hypotrichosis, nausea, vomiting, dyspepsia, flatulence, abdominal distension, abdominal discomfort, constipation, biliary dilatation, steatorrhoea, injection site reactions (pain, mass, induration, nodule, pruritis), laboratory investigation changes, weight decreased, decreased appetite, musculo-skeletal pain, myalgia. See full PI for further information. Dose: Acromegaly: For first time treatment the starting dose is 60 mg every 28 days; for patients previously treated with Somatuline LA every 14, 10 or 7 days, the starting dose is 60 mg, 90 mg or 120 mg respectively every 28 days. Dosage should be adjusted according to GH and/or IGF-1 response. Patients well controlled on lanreotide can be treated with 120mg every 42-56 days. Carcinoid Syndrome: 60 to 120 mg every 28 days, adjusted according to symptomatic relief. GEP-NETs: 120mg every 28 days; treatment should be continued for as long as needed for tumour control. Administration: Deep subcutaneous injection in the superior external quadrant of the buttock (healthcare professional or carer); or the upper, outer thigh (self-administration). Decision for injection by patient or carer to be made by a healthcare professional. Patients must be controlled on Somatuline Autogel and patients/carers must be motivated, competent and trained to inject. Storage: 2°C-8°C.
For further information about Somatuline® Autogel® contact Ipsen Pty Ltd: T (03)8544 8100 F (03)9562 5152 E email@example.com Ipsen Pty Ltd, Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley, VIC ,3150 Australia. ABN 47 095 036 909. Somatuline® Autogel® is a registered trade mark.