Octreotide

UK SPC for Octreotide 100 microgram/ml solution for injection/infusion (immediate-release). All figures are quoted in micrograms exactly as this SPC states them — do not convert to mg. ACROMEGALY TITRATION: 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), clinical symptoms and tolerability; for patients on a stable dose, assess GH and IGF-1 every 6 months; if no relevant reduction in GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting, therapy should be discontinued. OTHER LICENSED INDICATIONS FROM §4.2 — THE ROUTE IS LABELLED FOR EACH; DO NOT READ ACROSS ROUTES. (1) Gastro-entero-pancreatic endocrine tumours (SUBCUTANEOUS): initially 50 micrograms once or twice daily by s.c. injection, increased gradually according to clinical response, effect on levels of tumour-produced hormones (in carcinoid tumours, urinary 5-hydroxyindole acetic acid excretion) and tolerability to 100 to 200 micrograms three times daily; under exceptional circumstances higher doses may be required and maintenance doses have to be adjusted individually; in carcinoid tumours, if there is no beneficial response within 1 week of treatment at the maximum tolerated dose, therapy should not be continued. (2) Complications following pancreatic surgery (SUBCUTANEOUS): 100 micrograms three times daily by s.c. injection for 7 consecutive days, starting on the day of surgery at least 1 hour before laparotomy. (3) TSH-secreting pituitary adenomas (SUBCUTANEOUS): the dosage most generally effective is 100 micrograms three times a day by s.c. injection, adjusted according to the responses of TSH and thyroid hormones; at least 5 days of treatment will be needed to judge the efficacy. (4) Bleeding gastro-oesophageal varices (CONTINUOUS INTRAVENOUS INFUSION — different route, and an hourly RATE, not a per-injection dose): 25 micrograms/hour for 5 days by continuous i.v. infusion; octreotide can be used in dilution with physiological saline; in cirrhotic patients with bleeding gastro-oesophageal varices octreotide has been well tolerated at continuous i.v. doses of up to 50 micrograms/hour for 5 days, and §4.4 caps continuous intravenous administration at 50 micrograms/hour (see maxDose). ELDERLY: there is no evidence of reduced tolerability or altered dosage requirements in elderly patients. HEPATIC IMPAIRMENT: in patients with liver cirrhosis the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage. PAEDIATRIC: 'Experience with Octreotide in children is limited' — the SPC states no paediatric dose, so none is recorded here; verify any under-18 use against a children's formulary. MONITORING (§4.4): thyroid function should be monitored in patients receiving prolonged treatment; hepatic function should be monitored during therapy; ultrasonic examination of the gallbladder is recommended before treatment and at about 6- to 12-month intervals during therapy; octreotide may affect glucose regulation (both hyperglycaemia and hypoglycaemia are reported) and in patients with insulinomas may increase the depth and prolong the duration of hypoglycaemia.