OLATUTON

Posology Acromegaly It is recommended to start treatment with the administration of 20 mg Olatuton at 4-week intervals for 3 months. c. c. octreotide. Subsequent dosage adjustment should be based on serum growth hormone (GH) and insulin-like growth factor 1/somatomedin C (IGF-1) concentrations and clinical symptoms.

5 microgram/L), the dose may be increased to 30 mg every 4 weeks. If after 3 months, GH, IGF-1, and/or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks. For patients whose GH concentrations are consistently below 1 microgram/L, whose IGF-1 serum concentrations normalised, and in whom most reversible signs/symptoms of acromegaly have disappeared after 3 months of treatment with 20 mg, 10 mg Olatuton may be administered every 4 weeks.

However, particularly in this group of patients, it is recommended to closely monitor adequate control of serum GH and IGF-1 concentrations, and clinical signs/symptoms at this low dose of Olatuton. For patients on a stable dose of Olatuton, assessment of GH and IGF-1 should be made every 6 months.

Gastro-entero-pancreatic endocrine tumours Treatment of patients with symptoms associated with functional gastro-entero- pancreatic neuroendocrine tumours It is recommended to start treatment with the administration of 20 mg Olatuton at 4-week intervals.

c. octreotide should continue at the previously effective dosage for 2 weeks after the first injection of Olatuton. For patients in whom symptoms and biological markers are well controlled after 3 months of treatment, the dose may be reduced to 10 mg Olatuton every 4 weeks.

For patients in whom symptoms are only partially controlled after 3 months of treatment, the dose may be increased to 30 mg Olatuton every 4 weeks. c. octreotide is recommended at the dose used prior to the Olatuton treatment. This may occur mainly in the first 2 months of treatment until therapeutic concentrations of octreotide are reached.

1). Treatment with Olatuton for tumour control should be continued in the absence of tumour progression. Treatment of TSH-secreting adenomas Treatment with Olatuton should be started at a dose of 20 mg at 4-weekly intervals for 3 months before considering dose adjustment.

The dose is then adjusted on the basis of the TSH and thyroid hormone response. c. Therefore, no dose adjustment of Olatuton is necessary. c. v. it was shown that the elimination capacity may be reduced in patients with liver cirrhosis, but not in patients with fatty liver disease.

Summary of the safety profile 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.

, decreased thyroid stimulating hormone [TSH], decreased total T4, and decreased free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycaemia. Tabulated list of adverse reactions The following adverse drug reactions, listed in Table 1, have been accumulated from clinical studies with octreotide: Adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), including isolated reports.

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Table 1:

Adverse drug reactions reported in clinical studies 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. , decreased TSH, decreased total T4, and decreased free T4).

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 normalisation of insulin-like growth factor 1 (IGF-1) concentration in female acromegalic patients could potentially restore fertility.

6). Thyroid function should be monitored in patients receiving prolonged treatment with octreotide. Hepatic function should be monitored during octreotide therapy. Cardiovascular related events Common cases of bradycardia have been reported.

5). 8). Additionally, cases of cholangitis have been reported as a complication of cholelithiasis in patients taking octreotide prolonged-release injection in the post- marketing setting. Ultrasonic examination of the gallbladder before and at about 6-monthly intervals during octreotide prolonged-release injection therapy is recommended.

Glucose metabolism Because of its inhibitory action on growth hormone, glucagon, and insulin release, Olatuton may affect glucose regulation. Post-prandial glucose tolerance may be impaired. c. octreotide, in some instances, the state of persistent hyperglycaemia may be induced as a result of chronic administration.

Hypoglycaemia has also been reported. In patients with concomitant Type I diabetes mellitus, Olatuton is likely to affect glucose regulation, and insulin requirements may be reduced. c. administration may result in increases in 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.

1.