Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Sandostatin is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.
Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumours, e.g. carcinoid tumours with features of the carcinoid syndrome (see section 5.1).
Sandostatin is not an anti-tumour therapy and is not curative in these patients.
Prevention of complications following pancreatic surgery.
Emergency management to stop bleeding and to protect from re-bleeding owing to gastro-oesophageal varices in patients with cirrhosis. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy.
Treatment of TSH-secreting pituitary adenomas:
Initially 0.05 to 0.1 mg by subcutaneous (s.c.) injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH <2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on tolerability. In most patients, the optimal daily dose will be 0.3 mg. A maximum dose of 1.5 mg per day should not be exceeded. For patients on a stable dose of Sandostatin, assessment of GH and IGF-1 should be made every 6 months.
If no relevant reduction in GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting treatment with Sandostatin, therapy should be discontinued.
Initially 0.05 mg once or twice daily by s.c. injection. Depending on clinical response, effect on levels of tumour-produced hormones (in cases of carcinoid tumours, on the urinary excretion of 5-hydroxyindole acetic acid), and on tolerability, dosage can be gradually increased to 0.1 to 0.2 mg 3 times daily. Under exceptional circumstances, higher doses may be required. Maintenance doses have to be adjusted individually.
In carcinoid tumours, if there is no beneficial response within 1 week of treatment with Sandostatin at the maximum tolerated dose, therapy should not be continued.
0.1 mg 3 times daily by s.c. injection for 7 consecutive days, starting on the day of surgery at least 1 hour before laparotomy.
25 micrograms/hour for 5 days by continuous intravenous (i.v.) infusion. Sandostatin can be used in dilution with physiological saline.
In cirrhotic patients with bleeding gastro-oesophageal varices, Sandostatin has been well tolerated at continuous i.v. doses of up to 50 micrograms/hour for 5 days.
The dosage most generally effective is 100 micrograms three times a day by s.c. injection. The dose can be adjusted according to the responses of TSH and thyroid hormones. At least 5 days of treatment will be needed to judge the efficacy.
There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Sandostatin.
Experience with Sandostatin in children is limited.
In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.
Impaired renal function did not affect the total exposure (AUC) to octreotide administered as s.c. injection, therefore no dose adjustment of Sandostatin is necessary.
Sandostatin may be administered directly by subcutaneous (s.c.) injection or by intravenous (i.v.) infusion after dilution. For further instructions on handling and instructions for dilution of the medicinal product, refer to section 6.6.
A limited number of accidental overdoses of Sandostatin in adults and children have been reported. In adults, the doses ranged from 2,400-6,000 micrograms/day administered by continuous infusion (100-250 micrograms/hour) or subcutaneously (1,500 micrograms three times a day). The adverse events reported were arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatic steatosis, diarrhoea, weakness, lethargy, weight loss, hepatomegaly, and lactic acidosis.
In children, the doses ranged from 50-3,000 micrograms/day administered by continuous infusion (2.1-500 micrograms/hour) or subcutaneously (50-100 micrograms). The only adverse event reported was mild hyperglycaemia.
No unexpected adverse events have been reported in cancer patients receiving Sandostatin at doses of 3,000-30,000 micrograms/day in divided doses subcutaneously.
The management of overdosage is symptomatic.
3 years.
The product should be used immediately after opening.
Diluted solutions should be used immediately after preparation.
Store in the original package in order to protect from light.
Store in a refrigerator (2°C to 8°C). Do not freeze.
The ampoules may be stored below 30°C for up to two weeks.
For storage conditions after opening and after dilution, refer to section 6.3.
One-point-cut colourless, type I glass ampoule with two colour code rings containing clear colourless solution.
Sandostatin 50 microgram/1 ml: one blue and one yellow.
Sandostatin 100 microgram/1 ml: one blue and one green.
Sandostatin 500 microgram/1 ml: one blue and one pink.
Packs of three, five, six, ten, twenty and fifty ampoules packed in a cardboard tray which is placed in an outer box.
Multipacks of ten packs, each containing three ampoules.
Not all strengths or pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Ampoule is intended for single use only; it should be opened just prior to administration and any unused portion discarded.
Patients who are to self-administer the drug by s.c. injection must receive precise directions from the physician or the nurse.
To reduce local discomfort, it is recommended that the solution should be at room temperature before injection. Multiple injections at short intervals at the same site should be avoided.
Parenteral drug products should be inspected visually for discoloration and particulate matter prior to administration. For intravenous infusion the product must be diluted prior to administration. Sandostatin (octreotide acetate) is physically and chemically stable for 24 hours in sterile physiological saline solutions or sterile solutions of dextrose (glucose) 5% in water. However, because Sandostatin can affect glucose homeostasis, it is recommended that physiological saline solutions be used rather than dextrose. The diluted solutions are physically and chemically stable for at least 24 hours below 25°C. From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
The contents of one 500 microgram ampoule should normally be dissolved in 60 ml physiological saline, and the resulting solution should be infused by means of an infusion pump. This should be repeated as often as necessary until the prescribed duration of treatment is reached.
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