SANDOSTATIN LAR FOR INJECTION 30 mg

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION

**DOSAGE REGIMEN AND ADMINISTRATION** **Dosage regimen** **General target population** 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 USE AND HANDLING – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **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. Patients on treatment with s.c. Sandostatin can start treatment with Sandostatin LAR 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 normalized, 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. **Gastro-entero-pancreatic endocrine tumors** **Treatment of patients with symptoms associated with functional gastro-entero-pancreatic neuroendocrine tumors** 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. Patients on treatment with s.c. Sandostatin should continue 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 tumors 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. **Treatment of patients with 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 section PHARMACODYNAMICS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Treatment with Sandostatin LAR for tumor control should be continued in the absence of tumor progression. **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 therapeutic window of octreotide, no dose adjustment of Sandostatin LAR is necessary in patients with liver cirrhosis. **Geriatric patients (65 years or above)** 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 patients (below 18 years)** There is limited experience with the use of Sandostatin LAR in children.