Lanreotide

Registered South African indications:

• Acromegaly
• Neuroendocrine tumours (NETs) with carcinoid syndrome
• Gastroenteropancreatic neuroendocrine tumours (GEP-NETs)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Complicated, untreated lithiasis of the bile ducts
• Pregnancy
• Lactation

Cautions

• Diabetes mellitus
• Hypothyroidism
• Bradycardia

Forms avail. in SA and covered in this monograph: pfs

South African registered indications and dosages

Acromegaly
- Clinical symptoms
- When secretions of growth hormone (GH) and insulin-like growth hormone factor 1 (IGF-1) remain abnormal after surgery and/or radiotherapy

• SC: Initial: 90mg, every 28 days for 3 months; Dose should be individualised according to the response; Max: 120mg, every 42 or 56 days (See additional prescribing points)

Neuroendocrine tumours (NETs) with carcinoid syndrome
- Treatment of symptoms related to neuroendocrine tumours (NETs) with characteristics of the carcinoid syndrome

• SC: Initial: 90mg, every 28 days for 2 months; Dose should be adjusted according to the degree of symptomatic relief obtained; In case of an insufficient response judged by clinical symptoms (flushes and soft stools): Dose may be increased to 120mg, every 28 days (4 weeks); In case of a sufficient response judged by clinical symptoms (flushes and soft stools); Dose may be decreased to 60mg, every 28 days (4 weeks)

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs)
- Treatment of gastroenteropancreatic neuroendocrine tumours in adult patients with unresectable locally advanced or metastatic disease to improve progression-free survival

• SC: 120mg, every 28 days; Treatment should be continued for as long as effective for tumour control

Method of administration
Remove lanreotide from the refrigerator 30 minutes prior to administration, but keep the pouch sealed during this time
Lanreotide should be injected via the deep subcutaneous route in the superior external quadrant of the buttock or in the upper outer thigh. The injection should be administered by a healthcare professional

For patients on a stable dose regimen of lanreotide, the product may be administered either by the patient or by another trained person after appropriate training by a healthcare professional. In case of self-injection, the injection should be given in the upper outer thigh. The decision of administration by the patient or by another trained person, should be taken by a healthcare professional. Regardless of the site of injection, the skin should not be folded and the needle should be inserted rapidly to its full length, perpendicularly to the skin. The injection site should alternate between the right and left side

Each syringe is intended for single use only

See additional prescribing points

Not established for use in children

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Insomnia
• Dizziness
• Headache
• Lethargy
• Asthenia

Cardiovascular Disorders

• Sinus bradycardia
• Hot flushes

Gastrointestinal Disorders

• Diarrhoea
• Loose stools
• Abdominal pain
• Nausea and vomiting
• Constipation
• Flatulence
• Abdominal distension
• Abdominal discomfort
• Dyspepsia
• Steatorrhoea
• Discoloured faeces 
• Pancreatitis

Hepatobiliary Disorders

• Cholelithiasis
• Biliary dilatation
• Abnormal hepatic enzymes
• Increased bilirubin
• Increased alkaline phosphatase

Endocrine and Metabolic Disorders

• Hypoglycaemia
• Decreased appetite
• Hyperglycaemia
• Diabetes mellitus
• Increased glycosylated haemoglobin
• Decreased weight
• Decreased pancreatic enzymes 
• Decreased sodium

Musculoskeletal Disorders

• Musculoskeletal pain
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Hypotrichosis
• Injection site reactions

Immune, Blood and Lymphatic System Disorders

• Allergic reactions

• Ciclosporin
• Bromocriptine 
• Bradycardia inducing agents
• CYP3A4 substrates

• Serum growth hormone 
• Serum insulin-like growth factor 1 
• Glucose levels
• Thyroid functions
• Gallstone formation
• Vital signs

Acromegaly recommendations

• 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 growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels and by assessing changes in symptoms
• 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 1ng/ml and 2.5ng/ml
  • To increase the dose when the concentrations of GH are higher than 2.5ng/ml
• Patients well controlled on a first generation somatostatin analogue can be treated with a maximum dose of lanreotide 120mg every 42 or 56 days
• Long-term monitoring of symptoms, GH and IGF-1 levels should be undertaken as clinically indicated

Lanreotide is an octapeptide analogue of natural somatostatin. Like somatostatin, lanreotide is an inhibitor of various endocrine, neuroendocrine, exocrine and paracrine functions. It shows high binding affinity for human somatostatin receptors (SSTR) 2, 3 and 5, and reduced affinity for human SSTR 1 and 4. Activity at SSTR 2 and 5 is the primary mechanism considered to be responsible for growth hormone inhibition. Lanreotide exhibits a general exocrine anti-secretory action. It inhibits the basal secretion of motilin, gastric inhibitory peptide and pancreatic polypeptide, but has no significant effect on fasting secretin or gastrin secretion. Lanreotide inhibits meal-induced increases in superior mesenteric artery blood flow and portal venous blood flow. Lanreotide reduces prostaglandin E1-stimulated jejunal hydroelectrolytic secretion. Lanreotide reduces prolactin levels in patients treated long-term.

Injection (per 0.5ml) 60mg

• Somatuline Autogel 60 Pre-filled syringe (Sanofi) originator

Injection (per 0.5ml) 90mg

• Somatuline Autogel 90 Pre-filled syringe (Sanofi) originator

Injection (per 0.5ml) 120mg

• Somatuline Autogel 120 Pre-filled syringe (Sanofi) originator