Posology : מינונים

4.2.   Posology and method of administration
Sandostatin LAR may only be administered by deep intragluteal injection. The site of repeat intragluteal injections should be alternated between the left and right gluteal muscle (see 6.6 Instructions for use/handling).

Posology

Acromegaly
For patients who are adequately controlled with s.c. Sandostatin, it is recommended to start treatment with the administration of 20 mg Sandostatin LAR at 4-week intervals for 3 months.
Treatment with Sandostatin LAR can be started the day after the last dose of s.c. Sandostatin.
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.

For patients in whom, within this 3-month period, clinical symptoms and biochemical parameters (GH; IGF 1) are not fully controlled (GH concentrations still above 2.5 microgram/L), the dose may be increased to 30 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 Sandostatin LAR 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 Sandostatin LAR.

For patients on a stable dose of Sandostatin LAR, assessment of GH and IGF-1 should be made every 6 months.

For patients in whom surgery or radiotherapy is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective, a short test dosing period of s.c.
administration of Sandostatin is recommended to assess the response and systemic tolerability of octreotide prior to initiating treatment with Sandostatin LAR as described above.

Gastro-entero-pancreatic endocrine tumours

For patients in whom symptoms are adequately controlled with s.c. Sandostatin, it is recommended to start treatment with the administration of 20 mg Sandostatin LAR at 4-week intervals. The treatment with s.c. Sandostatin should be continued at the previously effective dosage for 2 weeks after the first injection of Sandostatin LAR.

For patients who were not previously treated with s.c. Sandostatin, it is recommended to start with the administration of s.c. Sandostatin at a dosage of 0.1 mg three times daily for a short period (approximately 2 weeks) to assess the response and systemic tolerability of octreotide before initiating the treatment with Sandostatin LAR as described above. For patients in whom symptoms and biological markers are well controlled after 3 months of treatment, the dose may be reduced to 10 mg Sandostatin LAR 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 Sandostatin LAR every 4 weeks.

For days when symptoms associated with gastro-entero-pancreatic tumours may increase during treatment with Sandostatin LAR, additional administration of s.c. Sandostatin is recommended at the dose used prior to the Sandostatin LAR treatment. This may occur mainly in the first 2 months of treatment until therapeutic concentrations of octreotide are reached.

Special populations

Renal Impairment
Impaired renal function did not affect the total exposure (AUC) to octreotide when administered s.c. as Sandostatin. Therefore, no dose adjustment of Sandostatin LAR is necessary.

Hepatic Impairment
In a study with Sandostatin administered s.c. and i.v. it was shown that the elimination capacity may be reduced in patients with liver cirrhosis, but not in patients with fatty liver disease. Due to the wide theraputic window of octreotide, no dose adjustment of Sandostatin LAR is necessary in patients with liver cirrhosis.


Geriatric Population


In a study with Sandostatin administered s.c., no dose adjustment was necessary in subjects  65 years of age. Therefore, no dose adjustment is necessary in this group of patients with Sandostatin LAR.

Pediatric Population
There is limited experience with the use of Sandostatin LAR in children.