Sandostatin/Sandostatin LAR Special Precautions

General: As GH-secreting pituitary tumours may sometimes expand, causing serious complications (eg, visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures are advisable.
The therapeutic benefits of a reduction in GH levels and normalization of 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 (see Use in Pregnancy & Lactation).
Thyroid function should be monitored in patients receiving prolonged treatment with octreotide.
Cardiovascular-Related Events: Cases of bradycardia have been reported (frequency: common). Dose adjustments of drugs eg, β-blockers, calcium channel blockers or agents to control fluid and electrolyte balance, may be necessary.
Gallbladder and Related Events: Cholelithiasis is a very common event during Sandostatin treatment and may be associated with cholecystitis and biliary duct dilatation (see Adverse Reactions). Additionally, cases of cholangitis have been reported as a complication of cholelithiasis inpatients taking Sandostatin LAR in the post-marketing setting. Ultrasonic examination of the gallbladder before and at about 6 monthly intervals during Sandostatin LAR therapy is however recommended.
Glucose Metabolism: Because of its inhibitory action on GH, glucagon and insulin release, Sandostatin/Sandostatin LAR 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. Hypoglycemia has also been reported (Sandostatin LAR).
In patients with concomitant type I diabetes mellitus, Sandostatin LAR is likely to affect glucose regulation and insulin requirements may be reduced by the administration of Sandostatin/Sandostatin LAR. In non-diabetics and Type II diabetics with partially intact insulin reserves, Sandostatin/Sandostatin LAR administration may result in increases in prandial or post-prandial glycaemia. It is therefore recommended to monitor glucose tolerance and antidiabetic treatment.
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 observed during initiation of Sandostatin therapy and at each change of dosage. Marked fluctuations of blood glucose concentration may possibly be reduced by smaller, more frequently administered doses.
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/Sandostatin LAR in patients who have a history of vitamin B₁₂ deprivation.
Sandostatin: Gastroenteropancreatic 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.
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 preexisting 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 SC injection site only at the highest dose (about 40 times the maximum human dose). No hyperplastic or neoplastic lesions occurred at the SC 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 Sandostatin in humans.
Effects on the Ability to Drive or Operate Machinery: No data exist on the effects of Sandostatin/Sandostatin LAR on the ability to drive and use machines.
Use in Children: There is very limited experience with the use of Sandostatin/Sandostatin LAR in children.