LANREOTIDE SUN

Posology Acromegaly The recommended starting dose is 60 to 120 mg administered every 28 days. Thereafter 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).

If the desired response is not obtained, the dose may be increased. 5 ng/ml. 5 ng/ml and 1 ng/ml, the dose can be maintained if age- adjusted IGF-1 level is normal. If complete control is obtained (based on GH levels under 1 ng/ml, normalised IGF-I levels and/or disappearance of symptoms), the dose may be decreased.

Patients well controlled on a somatostatin analogue can be treated with Lanreotide 120 mg every 42 or 56 days. For example, patients, who are well controlled on Lanreotide 60 mg injected every 28 days, can be treated with Lanreotide 120 mg every 56 days and patients, who are well controlled on Lanreotide 90 mg injected every 28 days, can be treated with Lanreotide 120 mg every 42 days.

Long term monitoring of symptoms, GH and IGF-I levels should be undertaken as clinically indicated. Treatment of symptoms associated with neuroendocrine tumours The recommended starting dose is 60 to 120 mg administered every 28 days.

Thereafter the dose should be individualised according to the degree of symptomatic relief obtained. The maximum recommended dose is 120 mg lanreotide every 28 days. Patients well controlled on a somatostatin analogue can be treated with lanreotide 120 mg every 42 or 56 days.

For example, patients, who are well controlled on lanreotide 60 mg injected every 28 days, can be treated with lanreotide 120 mg every 56 days and patients, who are well controlled on lanreotide 90 mg injected every 28 days, can be treated with lanreotide 120 mg every 42 days.

There should be close monitoring of symptoms when treatment is switched to the extended dosing interval. 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 120 mg administered every 28 days. The treatment with lanreotide is to be continued for as long as needed for tumour control. 2). 2).

Paediatric population:

The safety and efficacy of lanreotide in children and adolescents has not been established.

Method of administration:

Lanreotide 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, and after appropriate training, 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) Uncommo n (≥1/1,000 to <1/100) Post-marketing safety experience (frequency not known) Immune system disorders Allergic reactions (including angioedema, anaphylaxis, hypersensitivity) Metabolism and nutrition disorders Hypoglycaemia, decreased appetite**, hyperglycaemia , diabetes mellitus Psychiatric disorders Insomnia* Nervous system disorders Dizzines s, headache , lethargy* * Cardiac disorders Sinus bradycardia* Vascula r disorder s Hot flushes* Gastrointestinal disorders Diarrhoea, loose stools*, abdominal pain Nausea, vomiting, constipation, flatulence, abdominal distension, abdominal discomfort*, dyspepsia, steatorrhoea** Faeces discoloured* Pancreatic exocrine insufficiency, pancreatitis Hepatobiliary disorders Cholelithiasis Biliary dilatation* Cholecystitis, cholangitis Musculoskeletal and connective tissue disorders Musculoskeletal pain**, myalgia** Skin and subcutaneou s tissue disorders Alopecia, hypotrichosis* General disorders and administration site conditions Asthenia, fatigue, injection site reactions (pain, mass, induration, nodule, pruritus) Injection site abscess Investigations ALAT increased*, ASAT abnormal*, ALAT abnormal*, blood bilirubin increased*, blood glucose increased*, glycosylated haemoglobin increased*, weight decreased, pancreatic enzymes ASAT increased*, blood alkaline phosphatase increased*, blood bilirubin abnormal*, blood sodium decreased* decreased** * 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 suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Cholelithiasis and Complications of Cholelithiasis Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore, patients may need to be monitored periodically. 8). Gallstones that led to complications, including cholecystitis, cholangitis and pancreatitis requiring cholecystectomy in patients on lanreotide were reported after introduction to the market.

If complications of cholelithiasis are suspected, discontinue lanreotide and treat cholelithiasis accordingly. Hyperglycaemia and Hypoglycaemia Pharmacological studies in animals and humans show that lanreotide, like somatostatin and other somatostatin analogues, inhibits 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 acromegalic patients, though clinical hypothyroidism is rare. Thyroid function tests are recommended 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. Screening and appropriate treatment for PEI according to clinical guidelines should be considered in symptomatic patients. Pituitary tumour monitoring In patients with acromegaly, use of lanreotide is not exempt from the monitoring of the volume of the pituitary tumour.

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