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Flexible Dosing of Sandostatin^® LAR^®

Sandostatin LAR has a well-established safety profile. Most adverse events are gastrointestinal. The adverse events as well as injection-site pain are generally mild to moderate and of short-term duration.

(Please see the Novartis Core Labeling Text for more details)

Patients Not Currently Receiving Sandostatin^®1

For patients who were not previously treated with 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). Some patients may require doses of up to 1500 µg/day. The suggested daily dosage for patients with VIPomas is 200 µg to 300 µg in 2 to 4 divided doses (range 150 µg to 750 µg). The dosage may be adjusted on an individual basis to control symptoms, but doses above 450 µg/day are usually not required.

Patients should be maintained on SC Sandostatin for at least 2 weeks to assess side effects and determine tolerance. Patients who are thereafter considered "responders" and who tolerate the drug may be switched to Sandostatin LAR in the dosing scheme described below.

The control of diarrhoea and flushing begins after the first dose of Sandostatin LAR.²

Patients Currently Receiving Sandostatin¹

Patients who are currently receiving SC Sandostatin can be switched directly to
the slow-release depot formulation, Sandostatin LAR, using a dosage of 20 mg administered intragluteally at 4-week intervals for the initial 3 months, followed by dosage adjustment. Because of the need for serum octreotide to reach therapeutically effective levels following the initial injection of Sandostatin LAR, patients should continue to receive SC Sandostatin for at least 2 weeks in the same dosage they were taking before the switch. An exacerbation of symptoms may occur if SC injections are not continued for this period. Some patients may require 3 to 4 weeks of combination SC Sandostatin /Sandostatin LAR therapy.

After 3 months of receiving a 20-mg dosage Sandostatin LAR, the dosage may be increased to 30 mg every 4 weeks if symptoms are not adequately controlled.

Despite good overall control of symptoms, patients with carcinoid tumours and VIPomas often experience periodic exacerbation of symptoms (regardless of whether they are being maintained on SC Sandostatin or Sandostatin LAR ).

• During these periods, patients may be given SC Sandostatin for a few days at the dose they were receiving prior to switching to Sandostatin LAR
• When symptoms become controlled, the SC Sandostatin can be discontinued

Patients who achieve good control on a 20-mg dose may have their dose lowered to 10 mg for a trial period. If symptoms recur, the dosage should then be increased to 20 mg every 4 weeks. Many patients can be satisfactorily maintained at a 10-mg dosage every 4 weeks. A dose of 10 mg is not recommended as a starting dose, however, because therapeutically effective levels of Sandostatin are reached more rapidly with a 20-mg dose.

Click here for information on preparation and administration of Sandostatin.

References: 1. Sandostatin^® LAR^® Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2008. 2. Data on file, Novartis Pharma AG.