Sandostatin LAR Dosage/Direction for Use

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 Instructions for IM Injection of Sandostatin LAR).
Acromegaly: For patients who are adequately controlled with SC 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 SC Sandostatin. Subsequent dosage adjustment should be based on serum growth hormone (GH) and insulin-like growth factor I/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 >2.5 mcg/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 <1 mcg/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 SC administration of Sandostatin is recommended to assess the response and systemic tolerability of octreotide prior to initiating treatment with Sandostatin LAR as described previously.
Gastroenteropancreatic Endocrine Tumours: Symptoms Associated with Functional Gastroenteropancreatic Neuroendocrine Tumors: For patients in whom symptoms are adequately controlled with SC Sandostatin, it is recommended to start treatment with the administration of Sandostatin LAR 20 mg at 4-week intervals. The treatment with SC Sandostatin should be continued at the previously effective dosage for 2 weeks after the 1st injection of Sandostatin LAR.
For patients who were not previously treated with SC Sandostatin, it is recommended to start with the administration of SC Sandostatin at a dosage of 0.1 mg 3 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 previously.
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 gastroenteropancreatic tumours may increase during treatment with Sandostatin LAR, additional administration of SC 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.
Advanced Neuroendocrine Tumors of the Midgut or Unknown Primary Tumor Location: The recommended dose of Sandostatin LAR is 30 mg administered every 4 weeks (see Actions: Pharmacodynamics). Treatment with Sandostatin LAR for tumor control should be continued in the absence of tumor progression.
Patients with Impaired Renal Function: Impaired renal function did not affect the total exposure (AUC) to octreotide when administered SC as Sandostatin. Therefore, no dose adjustment of Sandostatin LAR is necessary.
Patients with Impaired Hepatic Function: In a study with Sandostatin administered SC and IV, 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 therapeutic window of octreotide, no dose adjustment of Sandostatin LAR is necessary in patients with liver cirrhosis.
Elderly: In a study with Sandostatin administered SC, no dose adjustment was necessary in patients ≥65 years. Therefore, no dosage adjustment is necessary in this group of patients with Sandostatin LAR.