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  • Sandostatin
    / Novartis


    Active Ingredient
    Octreotide 0.05, 0.1, 0.5 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 X 0.05 mg/ml

    partial basket chart 8201 19655

    Ampoule

    5 X 0.1 mg/ml

    partial basket chart 7775 19621

    Ampoule

    5 X 0.5 mg/ml

    partial basket chart 8651 19012

    Related information


    Dosage

    Acromegaly: Initially 0.05 to 0.1 mg by 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 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.
    Gastro-entero-pancreatic endocrine tumours: 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.
    Complications following pancreatic surgery: 0.1 mg 3 times daily by s.c. injection for 7 consecutive days, starting on the day of operation at least 1 hour before laparotomy.
    Bleeding gastro-oesophageal varices: 25 micrograms/hour for 5 days by continuous 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.
    Use in the elderly: There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Sandostatin.
    Use in children: Experience with Sandostatin in children is limited.
    Use in patients with impaired liver function: In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.
    Use in patients with impaired renal function: 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.


    Indications

    Prevention of complications following pancreatic surgery. 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 treatment 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 tumors:
    – Carcinoid tumors with features of the carcinoid syndrome.
    – VIPomas.
    – Glucagonomas.
    – Gastrinomas/Zollinger-Ellison syndrome, usually in conjunction with proton pump inhibitors, or H2-antagonist therapy.
    – Insulinomas, for pre-operative control of hypoglycemia and for maintenance therapy.
    – GRFomas.
    Sandostatin is not an anti-tumors therapy and is not curative in these patients. Emergency management of bleeding gastro-esophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.


    Contra-Indications

    Known hypersensitivity to octreotide or to any of the excipients.


    Special Precautions

    General: As GH-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. The therapeutic benefits of a reduction in growth hormone (GH) levels and normalization of insulin-like growth factor 1 (IGF-1) concentration in female acromegalic patients could potentially restore fertility. Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with octreotide. Thyroid function should be monitored in patients receiving prolonged treatment with octreotide.
    Cardiovascular related events: Common cases of bradycardia have been reported. Dose adjustments of drugs such as betablockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may be necessary.
    Gallbladder and related events: The incidence of gallstone formation with Sandostatin treatment is estimated to be between 15 to 30%. The incidence in the general population is 5 to 20%. Ultrasonic examination of the gallbladder before, and at about 6- to 12-month intervals during Sandostatin therapy is therefore recommended. The presence of gallstones in Sandostatin-treated patients is largely asymptomatic; symptomatic stones should be treated either by dissolution therapy with bile acids or by surgery. Further details are available from Novartis.
    GEP endocrine tumours: During the treatment of GEP endocrine tumours, there may be rare instances of sudden escape from symptomatic control by Sandostatin, with rapid recurrence of severe symptoms.
    Glucose metabolism: Because of its inhibitory action on growth hormone, glucagon, and insulin, Sandostatin may affect glucose regulation. Post-prandial glucose tolerance may be impaired and, in some instances, the state of persistent hyperglycaemia may be induced as a result of chronic administration. In patients with insulinomas, octreotide, because of its greater relative potency in inhibiting the secretion of GH and glucagon than that of insulin, and because of the shorter duration of its inhibitory action on insulin, may increase the depth and prolong the duration of hypoglycaemia. These patients should be closely monitored during initiation of Sandostatin therapy and at each change of dosage. Marked fluctuations in blood glucose concentration may possibly be reduced by smaller, more frequently administered doses.
    Insulin requirements of patients with type I diabetes mellitus therapy may be reduced by administration of Sandostatin. In non-diabetics and type II diabetics with partially intact insulin reserves, Sandostatin administration can result in prandial increases in glycaemia. It is therefore recommended to monitor glucose tolerance and antidiabetic treatment.
    Oesophageal varices: Since, following bleeding episodes from 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, an appropriate monitoring of blood glucose levels is mandatory.
    Local site reactions: In a 52-week toxicity study in rats, predominantly in males, sarcomas were noted at the s.c. injection site only at the highest dose (about 40 times the maximum human dose). No hyperplastic or neoplastic lesions occurred at the s.c. injection site in a 52-week dog toxicity study. There have been no reports of tumour formation at the injection sites in patients treated with Sandostatin for up to 15 years. All the information available at present indicates that the findings in rats are species specific and have no significance for the use of the drug in humans.
    Nutrition: Octreotide may alter absorption of dietary fats in some patients. Depressed vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide therapy. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin in patients who have a history of vitamin B12 deprivation.
    For full details see prescribing information.


    Side Effects

    The most frequent adverse reactions reported during octreotide therapy include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders. The most commonly reported adverse reactions in clinical trials with octreotide administration were diarrhoea, abdominal pain, nausea, flatulence, headache, cholelithiasis, hyperglycaemia and constipation. Other commonly reported adverse reactions were dizziness, localized pain, biliary sludge, thyroid dysfunction (e.g., decreased thyroid stimulating hormone [TSH], decreased Total T4, and decreased Free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycaemia. In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding. Pain or a sensation of stinging, tingling or burning at the site of s.c. injection, with redness and swelling, rarely lasting more than 15 minutes. Local discomfort may be reduced by allowing the solution to reach room temperature before injection, or by injecting a smaller volume using a more concentrated solution. Although measured faecal fat excretion may increase, there is no evidence to date that longterm treatment with octreotide has led to nutritional deficiency due to malabsorption. Occurrence of gastrointestinal side effects may be reduced by avoiding meals around the time of Sandostatin s.c. administration, that is, by injecting between meals or on retiring to bed. In very rare instances, acute pancreatitis has been reported within the first hours or days of Sandostatin s.c. treatment and resolved on withdrawal of the drug. In addition, cholelithiasisinduced pancreatitis has been reported for patients on long-term Sandostatin s.c. treatment. In both acromegalic and carcinoid syndrome patients, ECG changes were observed such as QT prolongation, axis shifts, early repolarisation, low voltage, R/S transition, early R wave progression, and non-specific ST-T wave changes. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac diseases.
    Gastrointestinal disorders Very common: Diarrhoea, abdominal pain, nausea, constipation, flatulence. Common: Dyspepsia, vomiting, abdominal bloating, steatorrhoea, loose stools, discolouration of faeces.
    Nervous system disorders Very common: Headache. Common: Dizziness.
    Endocrine disorders Common: Hypothyroidism, thyroid dysfunction (e.g., decreased TSH, decreased Total T4, and decreased Free T4).
    Metabolism and nutrition disorders Very common: Hyperglycaemia. Common: Hypoglycaemia, impaired glucose tolerance, anorexia.
    General disorders and administration site coditions Very common: Injection site localized pain.
    Investigations Common: Elevated transaminase levels.
    Skin and subcutaneous tissue disorders Common: Pruritus, rash , alopecia.
    Respiratory disorders Common: Dyspnoea.
    Cardiac disorders Common: Bradycardia.
    For full details see prescribing information.


    Drug interactions

    Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance may be necessary when Sandostatin is administered concomitantly. Dose adjustments of insulin and antidiabetic medicinal products may be required when Sandostatin is administered concomitantly. Sandostatin has been found to reduce the intestinal absorption of ciclosporin and to delay that of cimetidine. Concomitant administration of octreotide and bromocriptine increases the bioavailability of bromocriptine. Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should therefore be used with caution (e.g. quinidine, terfenadine).


    Pregnancy and Lactation

    Pregnancy: There are no adequate and well-controlled studies in pregnant women. Sandostatin should only be prescribed to pregnant woman under compelling circumstances.
    Lactation: It is unknown whether octreotide is excreted in human breast milk. Animal studies have shown excretion of octreotide in breast milk. Patients should not breast-feed during Sandostatin treatment.
    For full details see prescribing information.


    Overdose

    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 t.i.d.). The adverse events reported were arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, diarrhoea, weakness, lethargy, weight loss, hepatomegaly, and lactic acidosis1. 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.
    Treatment: The management of overdose is symptomatic.


    Important notes

    Incompatibilities: Octreotide is not stable in Total Parenteral Nutrition (TPN) solutions.
    Storage: Ampoules: Keep container in the outer carton in order to protect from light. For prolonged storage, Sandostatin ampoules must be stored at 2 to 8°C. Do not freeze. For day-to-day use, they may be stored not above 30°C for up to 2 weeks.
    Multidose vials: Keep container in the outer carton in order to protect from light. For prolonged storage, Sandostatin multidose vials must be stored at 2 to 8°C. Do not freeze. For day-to-day use, they may be stored not above 25°C for up to 2 weeks.


    Manufacturer
    Novartis Pharma Stein AG Switzerland
    Licence holder
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