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 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 child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide (see Use in pregnancy & lactations).
Thyroid function should be monitored in patients receiving prolonged treatment with octreotide.
Cardiovascular Related Events: Uncommon cases of bradycardia have been reported. 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: Development of gallstones has been reported in 15-30% of long-term recipients of SC Sandostatin. The prevalence in the general population (aged 40-60 years) is about 5-20%. Long-term exposure to Sandostatin LAR of patients with acromegaly or gastroenteropancreatic tumours suggests that treatment with Sandostatin LAR does not increase the incidence of gallstone formation, compared with SC treatment. Ultrasonic examination of the gallbladder before and at about 6-monthly intervals during Sandostatin LAR therapy is however recommended. If gallstones do occur, they are usually asymptomatic; symptomatic stones should be treated either by dissolution therapy with bile acids or by surgery.
Glucose metabolism: Because of its inhibitory action on growth hormone, glucagon and insulin release, Sandostatin LAR may affect glucose regulation. Post-prandial glucose tolerance may be impaired. As reported for patients treated with SC Sandostatin, in some instances, a state of persistent hyperglycemia may be induced as a result of chronic administration.
In patients with concomitant type I diabetes mellitus, Sandostatin LAR is likely to affect glucose regulation, and insulin requirements may be reduced. In non-diabetics and type II diabetics with partially intact insulin reserves, Sandostatin SC administration may result in increases in post-prandial glycemia. 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 hypoglycemia. These patients should be closely monitored.
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 LAR in patients who have a history of vitamin B₁₂ deprivation.
Guidelines for the Management of Patients During Sandostatin LAR Treatment with Respect to the Development of Gallstones: Patients should undergo a baseline ultrasound examination of the gallbladder prior to commencing octreotide treatment.
Periodic repeat ultrasound examination of the gallbladder should be performed, preferably at about 6-month intervals, throughout Sandostatin LAR treatment.
If stones are already present before the start of therapy, the potential benefit of Sandostatin LAR should be assessed against the potential risk associated with the gallstones. There is no evidence at present that Sandostatin LAR adversely affects the course or prognosis of preexisting gallstones.
Management of Patients Who Develop Gallstones in Association with Sandostatin LAR: Asymptomatic Gallstones: Sandostatin LAR may be continued depending on re-assessment of the benefit/risk ratio. Either way, no action is required except to continue monitoring with increased frequency if this is considered necessary.
Symptomatic Gallstones: Sandostatin LAR may be either stopped or continued depending on re-assessment of the benefit/risk ratio. Either way, the gallstones should be treated like any other symptomatic gallstones. Medically, this includes combined bile acid therapy (eg, chenodeoxycholic acid [CDCA] 7.5 mg/kg/day together with ursodeoxycholic acid [UDCA] 7.5 mg/kg/day) associated with ultrasound monitoring until the stones have completely disappeared.
Effects on the Ability to Drive or Operate Machinery: No data exist on the effects of Sandostatin LAR on the ability to drive and use machines.
Use in children: There is very limited experience with the use of Sandostatin LAR in children.