Octreotide powder for suspension for injection, all strengths
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Octreotide powder and solvent for suspension for injection.
Drugs List
Therapeutic Indications
Uses
Acromegaly : Symptomatic relief
Advanced neuroendocrine tumours of midgut
Gastroenteropancreatic (GEP) endocrine tumours : Symptomatic relief
Thyrotrophic adenoma
Symptomatic control and reduction of growth hormone and IGF-1 levels in patients with acromegaly.
Treatment of patients with acromegaly who are adequately controlled with subcutaneous octreotide, in whom surgery or radiotherapy is inappropriate or ineffective, in the interim period until radiotherapy becomes fully effective or as short term treatment (3-12 months) prior to pituitary surgery.
Treatment of patients with advanced neuroendocrine tumours of the midgut, or of unknown primary origin where non-midgut sites of origin have been excluded.
For the relief of symptoms of gastroenteropancreatic (GEP) endocrine tumours. e.g. carcinoid tumours with features of carcinoid syndrome, VIPomas and glucagonoma, in patients whose symptoms are adequately controlled on subcutaneous octreotide.
Current data does not support the use of octreotide as antitumour therapy in patients with pancreatic neuroendocrine tumours.
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.
Dosage
This monograph relates only to the intramuscular depot injection of octreotide.
A different formulation of short-acting octreotide for subcutaneous or intravenous use is available and the separate monograph should be consulted for further information.
Adults
Treatment of patients with acromegaly
For patients who have not received subcutaneous octreotide, a test dose (50-100 micrograms) of short-acting octreotide by subcutaneous injection is recommended to assess any adverse reaction prior to treatment with the depot formulation.
Adequate control should be reached with subcutaneous injections of octreotide (see appropriate monograph) before treatment with octreotide intramuscular depot injection.
Recommended starting dose is 20mg at 4 week intervals for 3 months.
Treatment with the depot injection can be started on the day after the last dose of subcutaneous octreotide.
Subsequent dosage adjustment should be determined by clinical symptoms, tolerability and monthly GH and IGF-1 levels.
For patients in whom clinical symptoms and biochemical parameters (GH and IGF 1) are not fully controlled (GH concentrations still above 2.5 micrograms/L (5mU/L)) the dose may be increased to 30mg every 4 weeks. If after 3 months, GH and IGF-1, and/or symptoms are not adequately controlled by 30mg, the dose may be increased to 40mg every 4 weeks.
For patients whose GH concentrations are consistently below 1 microgram/L (2mU/L), whose IGF 1 serum concentrations have normalised, and in whom most reversible signs/symptoms of acromegaly have disappeared after 3 months of treatment with 20mg of depot octreotide, the dose may be reduced to 10mg every 4 weeks. However, in this group of patients, serum GH and IGF-1 concentrations and clinical signs/symptoms should be monitored particularly closely.
In order to permit successful endocrine testing of the completeness of tumour removal 5-6 weeks post surgery, the last dose of octreotide should be administered at least 3-4 weeks prior to surgery.
Advanced neuroendocrine tumours of the midgut; or of unknown primary origin where non-midgut sites have been excluded
Recommended dose is 30mg every 4 weeks. Treatment for tumour control should be continued in the absence of tumour progression.
Gastroenteropancreatic endocrine tumours
Adequate control should be established with subcutaneous injections of octreotide (see appropriate monograph) before treatment with octreotide intramuscular depot injection.
Recommended starting dose is 20mg every 4 weeks.
Patients on treatment with subcutaneous octreotide should continue subcutaneous octreotide at the previous effective dosage for 2 weeks after the first depot injection.
For patients in whom symptoms are only partially controlled after 3 months of treatment, the dose may be increased to 30mg depot octreotide every 4 weeks.
For patients in whom symptoms and biological markers are well controlled after 3 months of treatment, the dose may be reduced to 10mg depot octreotide every 4 weeks.
For days when symptoms associated with gastroenteropancreatic tumours may increase during treatment with depot octreotide by intramuscular depot injection, additional administration of short-acting octreotide by subcutaneous injection is recommended at the dose used prior to the depot octreotide treatment.
Treatment of TSH-secreting adenomas
Recommended starting dose is 20mg every 4 weeks for 3 months.
Dose can then be adjusted based on TSH and thyroid hormone response.
Additional Dosage Information
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 at least 4 weeks prior to administration of lutetium (177Lu) oxodotreotide. If necessary, patients may be treated with short acting somatostatin analogues until 24 hours prior to administration of lutetium (177Lu) oxodotreotide. Octreotide treatment may resume within 4 to 24 hours after lutetium (177Lu) oxodotreotide administration.
Administration
For deep intramuscular injection only. Alternate the injection site for each dose between the left and right gluteal muscle.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Diabetes mellitus
Insulinoma
Vitamin B12 deficiency
Monitor gall bladder echography before treatment and at 6 monthly intervals
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 closely patients with insulinoma
Monitor for signs of pituitary tumour expansion
Monitor GH and IGF-1 levels regularly in acromegaly
Monitor hepatic function regularly
Monitor thyroid function in patients on prolonged treatment
Patients on stable dose for acromegaly: Monitor GH and IGF-1 every 6 months
May reduce absorption of vitamin B12
If evidence of tumour expansion appears, consider alternative procedures
Consider dose adjustment in hepatic cirrhosis
Female: Contraception advised even for women with a history of infertility
Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects). It is essential that all patients are closely monitored and if evidence of tumour expansion appears, alternative procedures considered.
Patients receiving treatment with octreotide have an estimated 15-30% incidence of formation of gallstones. Although there is no evidence to suggest that treatment with long acting octreotide increases the formation of gallstones compared with the subcutaneous formulation. Ultrasonic examination of the gallbladder before and at 6 monthly intervals during treatment is advisable. If gallstones do occur, they are usually asymptomatic and should be treated either by dissolution therapy with bile acids or by surgery.
Diabetes mellitus - Octreotide may affect glucose regulation as it inhibits growth hormone, glucagon and insulin secretion. Some cases of both hyperglycaemia and hypoglycaemia have been reported. 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.
Octreotide produces a relatively greater inhibitory affect on growth hormone and glucagon than on insulin, which may result in an increase the depth and prolong the duration of hypoglycaemia in patients with insulinomas. Such patients should be monitored carefully.
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.
Treatment with octreotide may restore fertility in acromegalic female patients. Such patients should, if appropriate, be advised to use adequate contraception during treatment.
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 contraindicated 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.
Side Effects
Abdominal distension
Abdominal pain
Abdominal tenderness
Abnormal faeces
Acute pancreatitis
Altered thyroid hormone levels
Anaphylaxis
Anorexia
Arrhythmias
Asthenia
Bloating
Bradycardia
Cholecystitis
Cholelithiasis
Cholestasis
Cholestatic hepatitis
Cholestatic jaundice
Constipation
Decrease in blood thyroxine values
Decreased glucose tolerance
Decreased TSH
Decreased vitamin-B12 absorption
Dehydration
Diarrhoea/loose stools
Dizziness
Dyspepsia
Dyspnoea
ECG changes
Epigastric pain
Flatulence
Gall bladder sludge
Gallstones
Gamma glutamyl transferase (GGT) increased
Hair loss (transient)
Headache
Hepatitis
Hyperbilirubinaemia
Hyperglycaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
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
Prolongation of QT interval
Pruritus
Rash
Steatorrhoea
Tachycardia
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: August 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.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Martindale: The Complete Drug Reference. 39th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2017.
Summary of Product Characteristics: Sandostatin LAR 10mg, 20mg, 30mg powder and solvent for injection. Novartis Pharmaceuticals UK Ltd. Revised July 2022.
Summary of Product Characteristics: Olatuton 10mg, 20mg, 30mg powder and solvent for prolonged-release suspension for injection. Teva UK Ltd. Revised March 2022.
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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