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LANREOTIDE ADVANZ PHARMA is a brand name for Lanreotide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lanreotide ADVANZ PHARMA solution for injection is indicated for: • The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment. •…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Acromegaly The recommended starting dose is 60 mg to 120 mg administered every 28 days. The dose may be varied according to the patient's response (judged by symptomatology and / or biochemical effect) or by the patient's possible experience with somatostatin analogues.
For example, in patients previously treated with lanreotide 30 mg with a dose every 14 days, the initial dose of Lanreotide ADVANZ PHARMA solution for injection should be 60 mg every 28 days, and in patients previously treated with lanreotide 30 mg with a dose every 10 days, the initial dose of Lanreotide ADVANZ PHARMA solution for injection should be 90 mg 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). For patients in whom clinical symptoms and biochemical parameters are not adequately controlled, the dose of Lanreotide ADVANZ PHARMA solution for injection may be increased to a maximum of 120 mg at 28-day intervals.
If complete control is obtained (based on GH levels under 1 ng/ml, normalised IGF1 levels and/or disappearance of symptoms), the dose may be decreased. Patients well controlled on a somatostatin analogue can alternatively be treated with Lanreotide ADVANZ PHARMA solution for injection 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 of Lanreotide ADVANZ PHARMA solution for injection is 120 mg administered every 28 days.
The treatment with Lanreotide ADVANZ PHARMA solution for injection 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 Lanreotide ADVANZ PHARMA solution for injection is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
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 disorders Diarrhoea, loose stools*, abdominal pain Nausea, vomiting, constipation, flatulence, abdominal distension, abdominal discomfort, dyspepsia, steatorrhoea** Faeces discoloured* Pancreatitis Hepatobiliary disorders Cholelithiasis Biliary dilatation* Cholecystitis, cholangitis 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 ASAT increased*, blood alkaline phosphatase increased*, blood bilirubin abnormal*, blood sodium decreased* decreased, pancreatic enzymes decreased** Immune system disorders Allergic reactions (including angioedema, anaphylaxis, 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 suspected adverse reactions after authorisation of the medicinal product is important.
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore, patients may need to be monitored periodically. There have been postmarketing 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. 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.
Slight decreases in thyroid function have been seen during treatment with lanreotide in patients with acromegaly, although clinical hypothyroidism is rare (<1%). Tests of thyroid function should be done where clinically indicated. 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).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Method of administration Lanreotide ADVANZ PHARMA solution for injection 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 ADVANZ PHARMA solution for injection, 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.
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.