LANREOTIDE IPSEN

Posology Acromegaly The recommended starting dose is 60 mg to 120 mg administered every 28 days. The dose should be individualised according to the response of the patient (as judged by a reduction in symptoms and/or a reduction in GH and/or IGF-1 levels).

5 ng/ml (approximately 5 mU/L) or IGF-1 greater than (age matched) normal), the dose of Lanreotide Ipsen may be increased to a maximum of 120 mg at 28 day intervals. Patients well controlled on a somatostatin analogue can alternatively be treated with Lanreotide Ipsen 120 mg every 42 - 56 days (6 to 8 weeks).

Long term monitoring of symptoms, GH and IGF-1 levels should be routinely carried out in all patients. Treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease The recommended dose is one injection of Lanreotide Ipsen 120 mg administered every 28 days.

The treatment with Lanreotide Ipsen should be continued for as long as needed for tumour control. Treatment of symptoms associated with neuroendocrine tumours The recommended starting dose is 60 to 120 mg administered every 28 days.

The dose should be adjusted according to the degree of symptomatic relief obtained. 2). 2). Paediatric population The safety and efficacy of Lanreotide Ipsen in children and adolescents has not been established. Method of Administration Lanreotide Ipsen is administered by deep subcutaneous injection in the superior external quadrant of the buttock or in the upper outer thigh.

For patients who receive a stable dose of Lanreotide Ipsen, and after appropriate training by healthcare professionals, the product may be administered either by the patient or by a trained person. In case of self-injection the injection should be given in the upper outer thigh.

The decision regarding administration by the patient or a trained person should be taken by a healthcare professional. Regardless of the injection site, the skin should not be folded and the needle should be inserted rapidly and to its full length, perpendicularly to the skin.

The injection site should alternate between the right and left side.

Undesirable effects reported by patients suffering from acromegaly and GEP-NETs treated with lanreotide in clinical trials are listed under the corresponding body organ systems according to the following classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).

The most commonly expected adverse drug reactions following treatment with lanreotide are gastrointestinal disorders (most commonly reported are diarrhoea and abdominal pain, usually mild or moderate and transient), cholelithiasis (often asymptomatic) and injection site reactions (pain, nodules and indurations).

The profile of undesirable effects is similar for all indications. System organ class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Post-marketing safety experience (frequency not known) Infections and infestations Injection site abscess Metabolism and nutrition disorders Hypoglycaemia, decreased appetite**, hyperglycaemia, diabetes mellitus Psychiatric disorders Insomnia* Nervous system disorders Dizziness, headache, lethargy** Cardiac disorders Sinus bradycardia* Vascular disorders Hot flushes* Gastrointestinal Diarrhoea, loose stools*, Nausea, vomiting, constipation, Faeces Pancreatic exocrine System organ class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Post-marketing safety experience (frequency not known) disorders abdominal pain flatulence, abdominal distension, abdominal discomfort*, dyspepsia, steatorrhoea** discoloured* insufficiency, Pancreatitis Hepatobiliary disorders Cholelithiasis Biliary dilatation* Cholangitis, Cholecystitis Musculoskeletal and connective tissue disorders Musculoskeletal pain**, myalgia** Skin and subcutaneous tissue disorders Alopecia, hypotrichosis* General disorders and administration site conditions Asthenia, fatigue, injection site reactions (pain, mass, induration, nodule, pruritus) Investigations ALAT increased*, ASAT abnormal*, ALAT abnormal*, blood bilirubin increased*, blood glucose increased*, glycosylated haemoglobin increased*, weight decreased, pancreatic enzymes decreased** ASAT increased*, blood alkaline phosphatase increased*, blood bilirubin abnormal*, blood sodium decreased* Immune system disorders Allergic reactions (including angioedema, anaphylaxis, System organ class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Post-marketing safety experience (frequency not known) hypersensitivity) * based on a pool of studies conducted in acromegalic patients ** based on a pool of studies conducted in patients with GEP-NETs Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.

Cholelithiasis and Complications of Cholelithiasis:

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore, patients may need to be monitored periodically. 8). There have been post-marketing reports of gallstones resulting in complications, including cholecystitis, cholangitis, and pancreatitis, requiring cholecystectomy in patients taking lanreotide.

If complications of cholelithiasis are suspected, discontinue lanreotide and treat appropriately.

Hyperglycaemia and Hypoglycaemia:

Pharmacological studies in animals and humans show that lanreotide, like somatostatin and other somatostatin analogues, inhibits the secretion of insulin and glucagon. Hence, patients treated with lanreotide may experience hypoglycaemia or hyperglycaemia.

Blood glucose levels should be monitored when lanreotide treatment is initiated, or when the dose is altered and any anti-diabetic treatment should be adjusted accordingly.

Hypothyroidism:

Slight decreases in thyroid function have been seen during treatment with lanreotide in patients with acromegaly, although clinical hypothyroidism is rare (<1%). Thyroid function tests should be done where clinically indicated.

Bradycardia:

In patients without underlying cardiac problems, lanreotide may lead to a decrease of heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to lanreotide treatment, sinus bradycardia may occur.

5).

Pancreatic function:

Pancreatic exocrine insufficiency (PEI) has been observed in some patients receiving lanreotide therapy for gastroenteropancreatic neuroendocrine tumours. Symptoms of PEI can include steatorrhea, loose stools, abdominal bloating and weight loss.

1.