Presentation and Status in Health Basket
1 x 60 mg/dose
1 x 90 mg/dose
1 x 120 mg/dose
Initiation of treatment Acromegaly The recommended dose is 60 to 120 mg administered every 28 days. In patients receiving a somatostatin analogue for the first time, the recommended starting dose is 60mg of Somatuline Autogel administered every 28 days. – in patients previously treated with this product. 30 mg powder and solvent for prolonged-release suspension for injection (I.M.) every 14 days, the initial dose should be 60 mg every 28 days; – in patients previously treated with this product. 30 mg powder and solvent for prolonged-release suspension for injection (I.M.) every 10 days, the initial dose should be 90 mg every 28 days; – in patients previously treated with this product. 30 mg powder and solvent for prolonged-release suspension for injection (I.M.) every 7 days, the initial dose should be 120 mg every 28 days. Carcinoid tumours The recommended starting dose is 90 mg every 28 days (4 weeks) during 2 months.
Adaptation of treatment: The treatment should be adjusted for each patient in a specialised unit. The dose should be individualised according to the response which is evaluated by monitoring plasma GH and IGF-1 levels and by assessing changes in clinical symptoms.
Acromegaly: It is recommended: – to reduce the dose when the concentrations are normalised (GH < 1 ng/ml and normalised IGF-1 and/or disappearance of clinical symptoms), – to maintain the dose when the concentrations of GH are between 2,5 ng/ml and 1 ng/ml, – to increase the dose when the concentrations of GH are higher than 2,5 ng/ml. Patients well controlled on a somatostatin analogue can be treated with this product 120 mg every 42 or 56 days.
Carcinoid tumours: In case of an insufficient response judged by clinical symptoms (flushes and soft stools), the dose may be increased to 120 mg every 28 days (4 weeks). In case of a sufficient response judged by clinical symptoms (flushes and soft stools), the dose may be decreased to 60 mg every 28 days (4 weeks).
Renal and/or hepatic impairment: In patients with impaired renal or hepatic function, no dosage adjustment is necessary.
Elderly patients: In elderly patients, no dosage adjustment is necessary.
Paediatric population: this product is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Treatment of acromegaly (when the treatment of growth hormone is not normalized after surgery and/or radiotherapy). Treatment of the clinical symptoms of carcinoid tumors (after a test injection). Treatment of primary thyrotropic adenomas responsible for hypothyroidism as a preparation for/or as a complement to surgery and/or radiotherapy, or where these therapies are unsuitable.
Hypersensitivity, pregnancy, lactation.
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore patients may need to be monitored periodically. It is advised, during prolonged treatment, to perform before treatment and every 6 months, an echography of the gallbladder. Pharmacological studies in animals and humans showed 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. Any antidiabetic treatment should be adjusted accordingly. In insulin-treated diabetic patients, the insulin doses will initially be reduced by 25 %, then adapted to the blood glucose level, which must be carefully controlled in these patients as soon as treatment begins. 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. In acromegalic patients and patients presenting with primitive thyrotropic adenomas, use of lanreotide is not exempt from the monitoring of the volume of the pituitary tumour. 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 pre-existing cardiac disorders, sinus bradycardia may occur. Caution should be taken when initiating treatment with lanreotide in patients with bradycardia. In carcinoid tumours, lanreotide must not be prescribed before having eliminated the presence of an obstructive intestinal tumour. The appearance of a significant and lasting increase of steatorrhoea justifies the complementary prescription of pancreatic extracts.
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 induration). The profile of undesirable effects is similar for other indications.
For full details see prescribing information.
Associations requiring precautions for use
Cyclosporine (oral use): decrease in cyclosporine blood levels (decrease in the intestinal cyclosporine absorption). Increase the cyclosporine dose under the control of circulating blood levels and reduction of doses after stopping lanreotide treatment.
Insulin, glitazones, repaglinide, sulphonylureas: risk of hypoglycaemia or hyperglycaemia: decrease in the needs of antidiabetic treatment following decrease or increase in endogen glucagon secretion. The glycaemic self monitoring must be reinforced and the posology of antidiabetic treatment during treatment by lanreotide should be adapted as required.
Bromocriptine: limited published data indicate that concomitant administration of somatostatin analogues and bromocriptine may increase the availability of bromocriptine. Concomitant administration of bradycardia inducing drugs (e.g. beta blockers) may have an additive effect on the slight reduction of heart rate associated with lanreotide. Dose adjustments of such concomitant medications may be necessary. The limited published data available indicate that somatostatin analogues may decrease the metabolic clearance of compounds known to be metabolised by cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that lanreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g. quinidine) should therefore be used with caution.
Pregnancy and Lactation
Pregnancy: Studies in animals showed no evidence of teratogenic effects associated with lanreotide during organogenesis. Reduced fertility was observed in female rats due to the inhibition of GH secretion at doses in excess of those achieved in humans at therapeutic doses. Data on a limited number of exposed pregnancies in human indicate no adverse effects of lanreotide on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Because animal studies are not always predictive of human responses, and the number of pregnancies in human exposed to lanreotide is very limited, therefore lanreotide should be administered to pregnant women only if clearly needed.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lanreotide is administered during lactation.
Fertility: Reduced fertility was observed in female rats due to the inhibition of GH secretion at doses in excess of those achieved in humans at therapeutic doses.
If overdose occurs, symptomatic management is indicated.