Octreotide parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of octreotide.
Drugs List
Therapeutic Indications
Uses
Acromegaly : Symptomatic relief
Bleeding oesophageal varices : treatment
Gastroenteropancreatic (GEP) endocrine tumours : Symptomatic relief
Prevention of complications following pancreatic surgery
Thyrotrophic adenoma
Acromegaly
- Symptomatic control and reduction of GH and IGF-1 levels in those inadequately controlled by pituitary surgery or radiotherapy, or where surgery is inappropriate or as interim treatment until radiotherapy becomes fully effective.
Relief of symptoms associated with gastroenteropancreatic (GEP) endocrine tumours
Such tumours include:
- Carcinoid tumours with features of carcinoid syndrome;
- VIPomas;
- Glucagonomas;
- Gastrinomas/Zollinger-Ellison syndrome;
- Insulinomas.
Prevention of complications following pancreatic surgery
Emergency treatment of oesophageal or gastric variceal haemorrhage in patients with cirrhosis
Treatment of TSH-secreting pituitary adenomas - When secretion has not normalised after surgery and/or radiotherapy; - In patients in whom surgery is inappropriate; - In irradiated patients, until radiotherapy is effective.
Unlicensed Uses
Nausea,vomiting in terminal care when other drugs ineffective/unavailable
Persistent hyperinsulinaemic hypoglycaemia in children and neonates
Palliative reduction of intestinal secretions and bowel obstruction related vomiting.
Unresponsive persistent hyperinsulinaemic hypoglycaemia in children and neonates.
Dosage
Adults
Acromegaly
Initially 0.05 to 0.1mg by subcutaneous injection every 8 to 12 hours.
In most patients the optimal daily dose is 0.3mg. A maximum daily dose of 1.5mg should not be exceeded.
GEP endocrine tumours
Initially 0.05mg by subcutaneous injection once or twice daily. Depending on clinical response and tolerability, dosage can be gradually increased to 0.1 to 0.2mg three times daily.
Higher doses may be required under exceptional circumstances.
In cases where a rapid response is required (e.g. carcinoid crises), the initial recommended dose may be given as an intravenous bolus injection (with ECG monitoring and after dilution in normal saline).
Prevention of complications following pancreatic surgery
0.1mg by subcutaneous injection three times daily for 7 consecutive days, starting on the day of the operation (at least one hour before laparotomy).
Gastro-oesophageal variceal haemorrhage
25 micrograms/hour by continuous intravenous infusion for 5 days.
In cirrhotic patients, octreotide can be well tolerated at continuous intravenous doses of up to 50 micrograms/hour for 5 days.
Treatment of TSH-secreting pituitary adenomas
0.1mg by subcutaneous injection three times daily. The dose can be adjusted according to the reponse of TSH and thyroid hormones. At least 5 days treatment is required to determine efficacy.
Palliative reduction of intestinal secretions and bowel obstruction related vomiting (unlicensed)
0.25 to 0.5mg/24 hours by continuous subcutaneous infusion. Doses of 0.75mg/24 hours, and occasionally higher, are sometimes required.
Children
Emergency treatment of oesophageal or gastric variceal haemorrhage (unlicensed)
Children aged 1 month to 18 years
1 microgram/kg/hour by continuous intravenous infusion. Higher doses may be required initially up to a maximum of 50 micrograms/hour.
Unresponsive persistent hyperinsulinaemic hypoglycaemia (unlicensed)
Children aged 1 month to 18 years old
Initially 1 to 2 micrograms/kg by subcutaneous injection every 4 to 6 hours, adjusted according to response. Up to 7 micrograms/kg every 4 hours may rarely be required.
Neonates
Unresponsive persistent hyperinsulinaemic hypoglycaemia (unlicensed)
Initially 2 to 5 micrograms/kg by subcutaneous injection every 6 to 8 hours, adjusted according to response. Up to 7 micrograms/kg every 4 hours may rarely be required.
Additional Dosage Information
Atrioventricular blocks (including complete atrioventricular block) were reported in patients receiving high doses of continuous infusion (100 micrograms/hour) or patients treated bolus octreotide intravenously (50 micrograms bolus followed by 50 micrograms/hour continuous infusion). Cardiac monitoring is required for patients on high doses of intravenous octreotide.
Use with radioactive somatostatin analogues
Due to the competitive binding of octreotide to somatostatin receptors, the efficacy of radioactive somatostatin analogues may be interfered.
Avoid administration of octreotide 24 hours prior to administration of lutetium (177Lu) oxodotreotide.
Administration
For subcutaneous or intravenous use only. If given intravenously, must be diluted prior to administration (and cardiac rhythm should be monitored).
Contraindications
Breastfeeding
Pregnancy
Precautions and Warnings
Children under 18 years
Cardiac disorder
Diabetes mellitus
Hepatic cirrhosis
Insulinoma
Vitamin B12 deficiency
Treatment to be initiated and supervised by a specialist
Monitor gall bladder echography before treatment and at 6 monthly intervals
Dosage adjustment in acromegaly to be based on monthly GH and IGF-1 levels
History of vitamin B12 deficiency: Monitor vit B12 levels during treatment
Monitor antidiabetic drug treatment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor cardiac function if high intravenous doses are used
Monitor closely patients with insulinoma
Monitor for signs of pituitary tumour expansion
Monitor hepatic function regularly
Monitor patients with cardiac disorders
Monitor thyroid function in patients on prolonged treatment
Oesophageal varices: Higher risk of developing insulin-dependent diabetes
Patients on stable dose for acromegaly: Monitor GH and IGF-1 every 6 months
Gastroenteropancreatic neoplasm:Sudden loss of symptomatic control possible
Acromegaly : Discontinue if no improvement within 3 months
Carcinoid tumour : Discontinue if no improvement within one week
If evidence of tumour expansion appears, consider alternative procedures
Consider dose adjustment in hepatic cirrhosis
Not licensed for use in children under 18 years
Female: Contraception advised even for women with a history of infertility
In patients with GEP endocrine tumours, sudden loss of symptomatic control may occur, with rapid recurrence of severe symptoms. Intravenous administration should only be given for the management of GEP tumours where a rapid response is required (e.g. carcinoid crises) and necessitates cardiac rhythm monitoring.
In patients with insulinoma, depth and duration of hypoglycaemia may be increased. Glucose levels should be monitored closely at the start of treatment and at each subsequent change of dose. Marked fluctuations of blood glucose may be reduced by more frequent administration.
Octreotide may cause both hyperglycaemia and hypoglycaemia as it inhibits growth hormone, glucagon and insulin secretion. Monitor blood glucose levels and antidiabetic treatment closely. Type 1 diabetics may experience reduced insulin requirements whilst in non-diabetics or type 2 diabetics with intact insulin reserves, octreotide can give rise to an increase in post-prandial glycaemia.
In patients with oesophageal varices, there is an increased risk for the development of insulin-dependent diabetes or for changes in insulin requirement in patients with pre-existing diabetes. In these patients, monitoring of blood glucose levels is mandatory.
Common cases of bradycardia have been reported. Dose adjustments of drugs such as beta-blockers, calcium channel blockers, or agents to control fluid and electrolyte balance may be necessary.
Pancreatic exocrine insufficiency (PEI) has been observed in patients treated with octreotide for gastroenteropancreatic neuroendocrine tumours. Symptomatic patients should be screened and treated for PEI, symptoms of PEI include steatorrhea, loose stools, abdominal bloating and weight loss.
Pregnancy and Lactation
Pregnancy
Octreotide is contraindictaed during pregnancy.
The manufacturer recommends to avoid the use of octreotide during pregnancy.
Safety for use during pregnancy has not been established as there is limited data of the use of octreotide in pregnant women. In pregnancy cases for which the outcome is known, congenital abnormalities were reported in about 4% of cases. However, no causal relationship to octreotide is suspected in these cases.
Animal studies have shown no teratogenic or foetotoxic effects but transient growth retardation was observed. At the time of writing, there is insufficient data to assess human embryo/foetal risk.
Lactation
Octreotide is contraindicated during breastfeeding.
The manufacturer recommends that patients should not breastfeed during octreotide treatment.
Animal studies have shown excretion of octreotide in breast milk. It is unknown if octreotide is excreted in human breast milk.
Counselling
Advise patients that gastrointestinal side effects may be reduced by avoiding meals around the time of injection.
Women of childbearing potential should be advised to use adequate contraception during treatment.
Side Effects
Abdominal distension
Abdominal pain
Abdominal tenderness
Abnormal faeces
Alopecia (transient)
Altered thyroid hormone levels
Anaphylaxis
Anorexia
Arrhythmias
Asthenia
Biliary colic
Bloating
Bradycardia
Cholecystitis
Cholelithiasis
Cholestasis
Cholestatic hepatitis
Cholestatic jaundice
Constipation
Decrease in blood thyroxine values
Decreased appetite
Decreased TSH
Decreased vitamin-B12 absorption
Dehydration
Diarrhoea/loose stools
Dizziness
Dyspepsia
Dyspnoea
ECG changes
Epigastric pain
Exanthema
Flatulence
Gall bladder sludge
Gamma glutamyl transferase (GGT) increased
Headache
Hepatic impairment
Hepatitis
Hyperbilirubinaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
Impaired postprandial glucose tolerance
Increase in alkaline phosphatase
Increase in serum transaminases
Intestinal obstruction
Jaundice
Local pain (injection site)
Local reaction at injection site
Nausea
Non specific ST-T wave changes
Pancreatitis
Persistent hyperglycaemia
Prolongation of QT interval
Pruritus
Rash
Skin reactions
Steatorrhoea
Tachycardia
Thirst
Thrombocytopenia
Thyroid abnormalities
Urticaria
Vomiting
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 2019
Reference Sources
Summary of Product Characteristics: Sandostatin 50, 100, 500 microgram/1 mL. Novartis Pharmaceuticals UK Ltd. Revised November 2021.
Summary of Product Characteristics: Octreotide 100 micrograms/mL solution for injection. Hospira UK Ltd. Revised May 2022.
Summary of Product Characteristics: Octreotide 500 micrograms/mL solution for injection. Hospira UK Ltd. Revised May 2022.
Summary of Product Characteristics: Octreotide Pre-filled syringe solution for injection. Kent Pharmaceutical Ltd. Revised April 2016.
Summary of Product Characteristics: Octreotide 50 micrograms/mL solution for injection. Sun Pharmaceutical UK Ltd. Revised January 2018.
Summary of Product Characteristics: Octreotide 100 micrograms/mL solution for injection. Sun Pharmaceutical UK Ltd. Revised January 2018.
Summary of Product Characteristics: Octreotide 200 micrograms/mL solution for injection. Sun Pharmaceutical UK Ltd. Revised January 2018.
Summary of Product Characteristics: Octreotide 500 micrograms/mL solution for injection. Sun Pharmaceutical UK Ltd. Revised January 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 November 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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