Lanreotide solution for injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing lanreotide.
Drugs List
Therapeutic Indications
Uses
Acromegaly : Symptomatic relief
Symptomatic treatment of neuroendocrine (particularly carcinoid) tumours
Treatment of 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.
Treatment of grade 1 and a subset of grade 2 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. Treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumours.
Dosage
This monograph relates only to the lanreotide injection solution formulation for deep subcutaneous injection. A different formulation of lanreotide as a powder for suspension for intramuscular injection is available and the separate monograph should be consulted.
Adults
Acromegaly
The goal of treatment in acromegaly is to reduce GH and IGF-1 levels and where possible to normalise these values.
Starting dose: 60mg to 120mg administered by deep subcutaneous injection every twenty eight days.
Dose should be titrated according to response, as judged by a reduction in symptoms and/or a reduction in Growth Hormone and/or Insulin-like Growth Factor-1 levels.
If clinical symptoms and biochemical parameters are not adequately controlled (GH concentrations still above 2.5ng/mL or IGF-1 greater than (age matched) normal), dose may be increased to a maximum of 120mg at twenty eight day intervals. Patients already well controlled on a somatostatin analogue: 120mg every six to eight weeks. Long term monitoring of symptoms, Growth Hormone and/or Insulin-like Growth Factor-1 levels should be routinely carried out in all patients.
Grade 1 and a subset of grade 2 gastroenteropancreatic neuroendocrine tumours in patients with unresectable locally advanced or metastatic disease
120mg administered every twenty eight days, continued for as long as tumour control is required.
Neuroendocrine tumours
Starting dose: 60mg to 120mg solution administered every twenty eight days, titrated according to the degree of symptomatic relief obtained.
Patients with Renal Impairment
Patients with severe renal impairment show an approximately 2-fold decrease in total serum clearance of lanreotide, with a consequent increase in half-life and area under the curve (AUC).
Administration
For subcutaneous injection.
Administer via the deep subcutaneous route into the superior, external quadrant of the buttock. The skin should be stretched prior to injection. The needle should be inserted rapidly to its full length, perpendicularly to the skin.
Rotation of injection sites, preferably between left and right sides, is recommended.
In patients whose treatment has been stabilised, and after appropriate training, the product may be administered by the patient or by a trained person. In the case of self-injection, the injection should be given in the upper outer thigh.
Contraindications
Children under 18 years
Breastfeeding
Precautions and Warnings
Bradycardia
Cardiac impairment
Diabetes mellitus
Gastrointestinal obstruction
Pregnancy
Patients with diabetes may experience fluctuations in blood glucose
Advise ability to drive/operate machinery may be affected by side effects
Monitor gall bladder echography before treatment and at 6 monthly intervals
Diabetic control may need adjustment
Monitor blood glucose
Monitor for signs of pituitary tumour expansion
Monitor thyroid function where clinically indicated
Discontinue treatment if cholelithiasis complications are suspected
May affect the absorption of concomitant oral drugs
Patients without underlying cardiac problems may experience a decreased heart rate without necessarily reaching the threshold of bradycardia.
Lanreotide may reduce gall bladder motility and lead to gallstone formation. Complications such as cholecystitis, cholangitis and pancreatitis, requiring cholecystectomy have been reported.
Exclude the presence of obstructive intestinal tumours in patients with carcinoid tumours before prescribing lanreotide.
Pregnancy and Lactation
Pregnancy
Use lanreotide with caution during pregnancy.
The manufacturer advises that it is preferable to avoid the use of lanreotide during pregnancy. There is limited data from the use of lanreotide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Schaefer (2015) notes that the use of hypothalamic releasing hormones or GnRH antagonists are rarely indicated in pregnancy (except for acromegaly). Although there are no current recommendations for lanreotide use during pregnancy, it is not contraindicated either.
Lactation
Lanreotide is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking lanreotide. It is unknown whether lanreotide is excreted in human breast milk. A risk to neonates cannot be excluded.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Abnormal faeces
Abscess
Allergic reaction
Alopecia
Alterations in pancreatic enzymes
Anaphylaxis
Angioedema
Anorexia
Asthenia
Biliary dilatation
Bloating
Cholangitis
Cholecystitis
Cholelithiasis
Constipation
Decreased appetite
Decreased serum sodium
Diabetes mellitus
Diarrhoea
Dizziness
Dyspepsia
Fatigue
Flatulence
Gallstones
Headache
Hot flushes
Hyperglycaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
Hypotrichosis
Impaired postprandial glucose tolerance
Increase in alkaline phosphatase
Increase in serum ALT/AST
Increased glycated haemoglobin (HbA1c) levels
Injection site reactions
Insomnia
Lethargy
Malaise
Musculoskeletal pain
Myalgia
Nausea
Pancreatitis
Serum bilirubin increased
Sinus bradycardia
Skin nodules
Steatorrhoea
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2017
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Somatuline Autogel 60mg, Somatuline Autogel 90mg, Somatuline Autogel 120mg. Ipsen Ltd. Revised May 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 July 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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