Prescribing information

 

   

SANDOSTATIN LAR is indicated for the treatment of:

  • Patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumours e.g. carcinoid tumours with features of the carcinoid syndrome or patients with advanced neuroendocrine tumours of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded.1
  • Patients with acromegaly in whom surgery is inappropriate or ineffective, or in the interim period until radiotherapy becomesfully effective.1

 

SANDOSTATIN LAR helps reduce patients’ symptoms  with sustained control over advanced midgut NETs2

In a prospective, randomised controlled trial, double-blinded SANDOSTATIN LAR was administered to 93 patients (10 mg, n=22; 20 mg, n=20; 30 mg, n=25) every 4 weeks and compared with open-label s.c. octreotide (n=26) every 8 hours for the treatment of carcinoid syndrome.2

The primary endpoint was treatment response, which was defined as either treatment success, partial treatment success, or treatment failure based on the degree and duration of suppression of carcinoid symptoms.2

The rate of complete or partial treatment success was similar in each of the four treatment arms of the study (s.c., 58.3%; 10 mg, 66.7%; 20 mg, 71.4%; 30 mg, 61.9%; P≥0.72 for all pairwise comparisons).2

The control of stool frequency was similar in all treatment groups.2

 

Graph showing a reduction in the meadian number of daily stools from baseline to 24 weeks with subcutaneous octreotide and 10 millgrams, 20 milligrams and 30 millgrams of Sandostatin LAR.

Figure adapted from Rubin J et al. 1999.2

 

Flushing episodes were well-controlled in the 20 mg LAR and s.c. groups whereas the 10 mg LAR treatment was least effective in the control of flushing.2

 

 Graph showing a reduction in the meadian number of daily flushing episodes from baseline to 24 weeks with subcutaneous octreotide and 10 millgrams, 20 milligrams and 30 millgrams of Sandostatin LAR.

Figure adapted from Rubin J et al. 1999.2

 

Tick box: A tick box with the text "Once octreotide stead-state concentrations are reached, Sandostatin LAR controls the symptoms of carcinoid syndrome at least as well as subcutaneous octreotide.

SANDOSTATIN LAR significantly lengthens time to tumour progression compared with placebo3

PROMID: SANDOSTATIN LAR 30 mg more than halved risk of progression or death versus placebo, in patients with advanced neuroendocrine tumours of the midgut.3

 

Diagram: Daigram illustrating the reduction in tumour progression, listing patient tumour type, Sandostatin and placebo arms, and the result "61 % of patient had a non-functioning tumour".

Figure adapted from Rinke A et al. 2009.3

 

The median time to progression or death in the SANDOSTATIN LAR-treated group was 14.3 months compared with 6.0 months in the placebo group, respectively (HR=0.34; 95% CI, 0.20 to 0.59; P=.000072).3

A 66.6% reduction in risk of progression or death was observed in the SANDOSTATIN LAR-treated group compared with 37.2% in the placebo group: for overall survival (HR=0.81; 95% CI, 0.30 to 2.18; P=.77).3

 

 Graph: Graph showing that Sandostatin LAR was more effective versus placebo in treatment naive patients from zero to 72 months since random allocation.

Figure adapted from Rinke A et al. 2009.3

 

The most frequent severe adverse events reported during this study include gastrointestinal disorders, hepatobiliary disorders and general health status (fatigue and fever).3

For more detailed safety data click here

SANDOSTATIN LAR is proven efficacious in treating patients with acromegaly4

A prospective, open-label international multicentre 48-week study evaluated the efficacy of SANDOSTATIN LAR in 68 patients who received 12 doses of SANDOSTATIN LAR, 10 mg–30 mg every 4 weeks. The primary endpoint was the assessment of serum GH and IGF-1 levels (biochemical response). Patients attended two centres who were retrospectively evaluated after a minimum follow-up of 18 months on SANDOSTATIN LAR.4

The following results were observed:4

44% of patients had reached a GH level 2.5 μg/L4

72% of patients experienced a clinically relevant reduction in mean GH <2.5 μg/L4

38.2% of patients experienced IGF-1 normalisation (75% with microadenomas and 33.3% with macroadenomas)4

The most frequent adverse events reported during this study include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders.4

For more detailed safety data click here

For more information, refer to the SANDOSTATIN LAR (octreotide acetate) Summary of Product Characteristics

 

Biochemical outcome categories were defined as follows; ‘total success’ was achieved when the mGH was ≤2·5 µg/l and age-adjusted IGF-1 was normal; partial success’ was defined as: (1) an mGH >2·5 µg/l and ≤5·0 µg/l and a decrease in IGF-I of 50% compared to baseline, or IGF-1 within the age-adjusted laboratory normal range, or (2) an mGH ≤2·5 µg/l and a decrease in IGF-I of ≥50% compared to the baseline level, but IGF-I levels still above the normal range and ‘treatment failure’ was defined as any other response.3

CI, confidence interval; GH, growth hormone; HR, hazard ratio; IGF-1, insulin-like growth factor 1; ITT, intent-to-treat; NETs, neuroendocrine tumours; PROMID, placebo-controlled, double-blind, prospective, randomised study on the effect of SANDOSTATIN® LAR® in the control of tumour growth in patients with metastatic neuroendocrine midgut tumours; s.c, subcutaneous.

References

  1. SANDOSTATIN® LAR®. Summary of Product Characteristics. December 2020.
  2. Rubin J, et al. J Clin Oncol. 1999;17:600–606.
  3. Rinke A, et al. J Clin Oncol. 2009;27:4656–4663.
  4. Mercado M, et al. Clin Endocrinol (Oxf). 2007;66:859–868.
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UK | May 2021 | 104728
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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