Sandostatin LAR

Sandostatin LAR Special Precautions

octreotide

Manufacturer:

Novartis Healthcare

Distributor:

Novartis Healthcare
Full Prescribing Info
Special Precautions
General: As GH-secreting pituitary tumors may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumor 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 & 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 such as beta-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 Reacions). Additionally, cases of cholangitis have been reported as a complication of cholelithiasis in patients 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 recommended.
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 s.c. Sandostatin, in some instances, a state of persistent hyperglycemia may be induced as a result of chronic administration. Hypoglycemia has also been reported.
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 s.c. 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.
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