Drugs List

Therapeutic Indications

Uses

Acromegaly : Symptomatic relief
Symptomatic treatment of neuroendocrine (particularly carcinoid) tumours
Thyrotrophic adenoma

Acromegaly:
Treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Hormone (IGF-1) remain abnormal after surgery and/or radiotherapy.

Neuroendocrine Tumours:
Treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumours.

Thyrotrophic Adenomas:
Treatment of thyrotrophic adenomas when the circulating level of Thyroid Stimulating Hormone (TSH) remains inappropriately high after surgery and/or radiotherapy.

Administration

For intramuscular injection.

Rotation of the injection site is recommended.

Contraindications

Children under 18 years

Precautions and Warnings

Breastfeeding
Cardiac impairment
Diabetes mellitus
Gastrointestinal obstruction
Insulinoma
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Monitor gall bladder ECHO before treatment & as clinically indicated after
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 treated with lanreotide may experience hypoglycaemia or hyperglycaemia. Therefore, blood glucose levels should be monitored in all patients when lanreotide treatment is initiated or the dose altered. In diabetic patients insulin or oral antidiabetic requirements should be adjusted accordingly. Patients with underlying cardiac problems may experience a decreased heart rate without necessarily reaching the threshold of bradycardia. In patients with cardiac disorders prior to treatment, sinus bradycardia may occur. Caution is advised with treatment of lanreotide in patients with bradycardia. An additive effect on the reduction of heart rate may be seen as a result of concomitant administration and dose adjustments of such coadministered drugs may be necessary. Lanreotide may reduce gall bladder motility and lead to gallstone formation. Complications such as cholecystitis, cholangitis and pancreatitis, requiring cholecystemctomy have been reported. Gall bladder echography is advisable before treatment and as clinically indicated, or at six to twelve monthly intervals, thereafter. Exclude the presence of obstructive intestinal tumours in patients with carcinoid tumours before prescribing lanreotide. The gastrointestinal effects of lanreotide may reduce the intestinal absorption of co-administered drugs. Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, although clinical hypothyroidism is rare. Tests of thyroid function should be done where clinically indicated. Growth hormone-secreting pituitary tumours can expand during treatment with somatostatin analogues. Patients should be monitored for signs of tumour expansion (e.g. visual field defects).

Pregnancy and Lactation

Pregnancy

Use lanreotide with caution during pregnancy.

The manufacturer advises lanreotide should be administered to pregnant women only if clearly needed. Data on a limited number of exposed pregnancies indicate no adverse effects of lanreotide on pregnancy or on the health of the new born child. Schaefer states that inadvertent use during pregnancy is not grounds for either termination or invasive diagnostic procedures. Studies in animals showed no evidence of teratogenic effects associated with lanreotide powder for suspension for injection during organogenesis.

Lactation

Use lanreotide with caution during breastfeeding.

The manufacturer recommends exercising caution when using lanreotide during breastfeeding. It is unknown whether lanreotide is excreted in human breast milk. Schaefer suggests that due to the low oral bioavailability of hypothalamic and pituitary hormones, toxic effects are not expected in nursing infants and therefore use for appropriate indications during breastfeeding is acceptable.

Side Effects

Abdominal discomfort
Abdominal distension
Abdominal pain
Abnormal faeces
Abscess
Acute pancreatitis
Allergic reaction
Alopecia
Alterations in hepatic enzymes
Alterations in pancreatic enzymes
Anaphylaxis
Angioedema
Asthenia
Biliary dilatation
Bradycardia
Cholangitis
Cholecystitis
Cholelithiasis
Constipation
Decreased appetite
Decreased serum sodium
Diabetes mellitus
Diarrhoea/loose stools
Dizziness
Dyspepsia
Fatigue
Flatulence
Gallstones
Gastro-intestinal symptoms
Headache
Hot flushes
Hyperglycaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
Hypotrichosis
Increase in alkaline phosphatase
Increased glycated haemoglobin (HbA1c) levels
Injection site reactions
Insomnia
Lethargy
Musculoskeletal pain
Myalgia
Nausea
Pruritus
Serum bilirubin increased
Skin nodules
Steatorrhoea
Vomiting
Weight loss

Presentation

Powder for suspension for injection of lanreotide (as lanreotide acetate).

Drugs List

Therapeutic Indications

Uses

Acromegaly : Symptomatic relief
Symptomatic treatment of neuroendocrine (particularly carcinoid) tumours
Thyrotrophic adenoma

Acromegaly:
Treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Hormone (IGF-1) remain abnormal after surgery and/or radiotherapy.

Neuroendocrine Tumours:
Treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumours.

Thyrotrophic Adenomas:
Treatment of thyrotrophic adenomas when the circulating level of Thyroid Stimulating Hormone (TSH) remains inappropriately high after surgery and/or radiotherapy.

Dosage

This monograph relates only to lanreotide powder for suspension for injection. A different formulation of lanreotide as a solution for injection is available and the separate monograph should be consulted.

Adults

Administration

For intramuscular injection.

Rotation of the injection site is recommended.

Contraindications

Children under 18 years

Precautions and Warnings

Breastfeeding
Cardiac impairment
Diabetes mellitus
Gastrointestinal obstruction
Insulinoma
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Monitor gall bladder ECHO before treatment & as clinically indicated after
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 treated with lanreotide may experience hypoglycaemia or hyperglycaemia. Therefore, blood glucose levels should be monitored in all patients when lanreotide treatment is initiated or the dose altered. In diabetic patients insulin or oral antidiabetic requirements should be adjusted accordingly. Patients with underlying cardiac problems may experience a decreased heart rate without necessarily reaching the threshold of bradycardia. In patients with cardiac disorders prior to treatment, sinus bradycardia may occur. Caution is advised with treatment of lanreotide in patients with bradycardia. An additive effect on the reduction of heart rate may be seen as a result of concomitant administration and dose adjustments of such coadministered drugs may be necessary. Lanreotide may reduce gall bladder motility and lead to gallstone formation. Complications such as cholecystitis, cholangitis and pancreatitis, requiring cholecystemctomy have been reported. Gall bladder echography is advisable before treatment and as clinically indicated, or at six to twelve monthly intervals, thereafter. Exclude the presence of obstructive intestinal tumours in patients with carcinoid tumours before prescribing lanreotide. The gastrointestinal effects of lanreotide may reduce the intestinal absorption of co-administered drugs. Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, although clinical hypothyroidism is rare. Tests of thyroid function should be done where clinically indicated. Growth hormone-secreting pituitary tumours can expand during treatment with somatostatin analogues. Patients should be monitored for signs of tumour expansion (e.g. visual field defects).

Pregnancy and Lactation

Pregnancy

Use lanreotide with caution during pregnancy.

The manufacturer advises lanreotide should be administered to pregnant women only if clearly needed. Data on a limited number of exposed pregnancies indicate no adverse effects of lanreotide on pregnancy or on the health of the new born child. Schaefer states that inadvertent use during pregnancy is not grounds for either termination or invasive diagnostic procedures. Studies in animals showed no evidence of teratogenic effects associated with lanreotide powder for suspension for injection during organogenesis.

Lactation

Use lanreotide with caution during breastfeeding.

The manufacturer recommends exercising caution when using lanreotide during breastfeeding. It is unknown whether lanreotide is excreted in human breast milk. Schaefer suggests that due to the low oral bioavailability of hypothalamic and pituitary hormones, toxic effects are not expected in nursing infants and therefore use for appropriate indications during breastfeeding is acceptable.

Side Effects

Abdominal discomfort
Abdominal distension
Abdominal pain
Abnormal faeces
Abscess
Acute pancreatitis
Allergic reaction
Alopecia
Alterations in hepatic enzymes
Alterations in pancreatic enzymes
Anaphylaxis
Angioedema
Asthenia
Biliary dilatation
Bradycardia
Cholangitis
Cholecystitis
Cholelithiasis
Constipation
Decreased appetite
Decreased serum sodium
Diabetes mellitus
Diarrhoea/loose stools
Dizziness
Dyspepsia
Fatigue
Flatulence
Gallstones
Gastro-intestinal symptoms
Headache
Hot flushes
Hyperglycaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
Hypotrichosis
Increase in alkaline phosphatase
Increased glycated haemoglobin (HbA1c) levels
Injection site reactions
Insomnia
Lethargy
Musculoskeletal pain
Myalgia
Nausea
Pruritus
Serum bilirubin increased
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: September 2019

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 16 September 2019.

Martindale: The Complete Drug Reference. 39th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2017.

Summary of Product Characteristics: Somatuline LA. Ipsen Ltd. Revised December 2019.