Sandostatin® LAR Depot (octreotide acetate for injectable suspension) should be administered by a trained healthcare professional. It is important to closely follow the mixing instructions included in the packaging. Sandostatin® LAR Depot must be administered immediately after mixing. Sandostatin® LAR Depot should be administered intragluteally at 4-week intervals.
Administration of Sandostatin® LAR Depot at intervals greater than 4 weeks is not recommended. Injection sites should be rotated in a systematic manner to avoid irritation. Deltoid injections should be avoided due to significant discomfort at the injection site when given in that area.
In this section, you'll find the following information about dosing Sandostatin® LAR Depot:
- Dosing Flow Chart
- Dosing for Patients Not Currently Receiving Octreotide Acetate
- Dosing for Patients Currently Receiving Immediate Release Sandostatin® Injection
- Special Populations—Renal Failure
- Patient Monitoring
Dosing Flow Chart
*For patients with carcinoid tumors, starting doses of immediate release Sandostatin® (octreotide acetate) Injection range from 100 mcg/day to 600 mcg/day in 2 to 4 divided doses. For patients with VIPomas, starting dosages range from 200 mcg/day to 300 mcg/day in 2 to 4 divided doses. Read the full prescribing information for Sandostatin® LAR Depot.
†Supplemental Immediate Release Therapy: Despite good overall control of symptoms, patients with carcinoid tumors and VIPomas often experience periodic symptom flare-ups due to disease progression and/or environmental factors. During a flare-up, patients may be treated with immediate release Sandostatin® Injection for several days at the dosage they were receiving before the switch. When symptoms are again under control, the supplemental immediate release Sandostatin® Injection treatment may be discontinued.
Patients Not Currently Receiving Octreotide Acetate1
Patients not currently receiving octreotide acetate should begin therapy with immediate release Sandostatin® Injection. The suggested daily dosage for carcinoid tumors during the first 2 weeks of therapy ranges from 100 mcg/day to 600 mcg/day in 2 to 4 divided doses (mean daily dosage is 300 mcg/day). Some patients may require doses of up to 1500 mcg/day. The suggested daily dosage for VIPomas is 200 mcg to 300 mcg in 2 to 4 divided doses (range 150 mcg to 750 mcg); dosage may be adjusted on an individual basis to control symptoms but usually doses above 450 mcg/day are not required.
Immediate release Sandostatin® Injection should be continued for at least 2 weeks. Thereafter, patients who are considered "responders" to octreotide acetate and who tolerate the drug may be switched to Sandostatin® LAR Depot in the dosage regimen described below.
Patients Currently Receiving Immediate Release Sandostatin® Injection1
Patients currently receiving immediate release Sandostatin® Injection can be switched to Sandostatin® LAR Depot in a dosage of 20 mg given intragluteally at 4-week intervals for 2 months. Deltoid injections are to be avoided because of significant discomfort at the injection site when given in that area. Gluteal injection sites should be alternated to avoid irritation. Because of the need for serum octreotide to reach therapeutically effective levels following initial injection of Sandostatin® LAR Depot, carcinoid tumor and VIPoma patients should continue to receive immediate release Sandostatin® Injection for at least 2 weeks after the same dosage that they were taking before the switch. Failure to continue subcutaneous injections through this period may result in exacerbation of symptoms. (Note: Some patients may require 3 or 4 weeks of such therapy.)
After 2 months of a 20-mg dosage of Sandostatin® LAR Depot, dosage may be increased to 30 mg every 4 weeks if symptoms are not adequately controlled. 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, dosage should then be increased to 20 mg every 4 weeks. Many patients can, however, 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 octreotide are reached more rapidly with a 20-mg dose.
Dosages higher than 30 mg are not recommended because there is no information on their usefulness.
Despite good overall control of symptoms, patients with carcinoid tumors and VIPomas often experience periodic exacerbation of symptoms (regardless of whether they are being maintained on immediate release Sandostatin® Injection or Sandostatin® LAR Depot). During these periods, they may be given immediate release Sandostatin® Injection for a few days at the dosage they were receiving prior to switching to Sandostatin® LAR Depot. When symptoms are again controlled, the immediate release Sandostatin® Injection can be discontinued.
Administration of Sandostatin® LAR Depot at intervals greater than 4 weeks is not recommended because there is insufficient information on whether such patients could be adequately controlled.
Special Populations: Renal Impairment1
In patients with renal failure requiring dialysis, the starting does should be 10 mg every 4 weeks. In other patients with renal impairment, the starting dose should be similar to a non-renal patient's (ie, 20 mg every 4 weeks).
Patient Monitoring1
Continued patient monitoring during treatment is necessary to assess therapeutic efficacy and safety. Laboratory tests that may be helpful as biochemical markers in determining and following patients' responses include:
- Vitamin B12 levels: long-term therapy with Sandostatin® LAR Depot may depress vitamin B12 levels and result in abnormal Schilling's tests in some patients
- Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) during chronic octreotide therapy
- Carcinoid syndrome—CgA, 5-HIAA, plasma serotonin, and plasma substance P
- VIPoma (VIP)—serum zinc concentrations: reversal of fluid loss in patients receiving total parenteral nutrition due to excessive fluid loss from the GI tract may result in excessive increases
Read the Prescribing Information for Sandostatin® LAR Depot
Important Safety Information
Carcinoid Syndrome:
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors and for the long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (62%), gastrointestinal disorders (14% to 38%), and injection-site pain (20% to 50%). Hypoglycemia (4%), hyperglycemia (27%), sinus bradycardia (19%), conduction abnormalities (9%), and arrhythmias (3%) have been reported.
The controlled clinical trials that support the marketing clearance for Sandostatin® LAR Depot did not include determination of effect on tumor size or rate of growth. Sandostatin® LAR Depot is not indicated for tumor shrinkage.
Acromegaly
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (52%), gastrointestinal disorders (7% to 36%), and injection-site pain (2% to 11%). Hypoglycemia (2%), hyperglycemia (15%), and hypothyroidism (2%) have been reported. While not measured in acromegalic patients receiving Sandostatin® LAR Depot, ECG changes have been reported in patients receiving immediate release Sandostatin® Injection; the degree to which these abnormalities are related to octreotide acetate is not clear, as many acromegalics have cardiovascular disease. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
