Dosing Sandostatin LAR® Depot
Click on a selection in the table for dosing recommendations for patients taking Sandostatin LAR® Depot (octreotide acetate for injectable suspension):
| Carcinoid Syndrome | Acromegaly |
|---|---|
General Information
Sandostatin LAR® Depot (octreotide acetate for injectable suspension) must be administered under the supervision of a physician. 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 because there is no adequate information on whether such patients could be satisfactorily controlled. Deltoid injections are to be avoided because of significant discomfort at the injection site when given in that area. Sandostatin LAR® Depot should never be administered by the intravenous (IV) or subcutaneous route. There is no direct relationship between dosage of immediate release Sandostatin® (octreotide acetate) Injection and dosage of Sandostatin LAR® Depot (octreotide acetate for injectable suspension). When beginning treatment with Sandostatin LAR® Depot please follow the recommendations printed below.
Carcinoid Dosing Flow Chart
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Patients Not Currently Receiving Octreotide Acetate — Carcinoid Syndrome
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 to 600 mcg/day in 2 to 4 divided doses (mean daily dosage is 300 mcg). Some patients may require doses of up to 1500 mcg/day. The suggested daily dosage for VIPomas is 200 to 300 mcg in 2 to 4 divided doses (range 150 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® Injection — Carcinoid Syndrome
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 Failure — Carcinoid Syndrome
In patients with renal failure requiring dialysis, the half-life of octreotide may be increased, necessitating adjustment of the maintenance dosage.
Patient Monitoring — Carcinoid Syndrome
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 — Chromogranin A (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.
Patients Not Currently Receiving Octreotide Acetate — Acromegaly
Patients not currently receiving octreotide acetate should begin therapy with immediate release Sandostatin® (octreotide acetate) Injection given subcutaneously in an initial dose of 50 mcg tid. Beginning with this low dose may permit adaptation to adverse gastrointestinal effects for patients who require higher doses. Multiple growth hormone (GH) determinations at 0 to 8 hours after a dose of immediate release Sandostatin® Injection will guide dosage titration. The goal is to attempt to normalize GH and insulin-like growth factor I (IGF-1) (somatomedin C) levels. Most patients require doses of 100 mcg to 200 mcg tid for maximum effect, but some patients require up to 500 mcg tid. Injection sites should be rotated in a systematic manner to avoid irritation (1).
Although responsiveness of GH to octreotide acetate can be ascertained quickly, patients should be maintained on immediate release Sandostatin® Injection for at least 2 weeks to determine tolerance to octreotide (1).
The most common adverse events are gastrointestinal, which usually begin within the first few days of administration and usually subside within 2 to 8 weeks. In clinical trials, less than 3% of patients discontinued immediate release Sandostatin® Injection because of gastrointestinal (GI) symptoms (1). Patients who are considered to be "responders" to the drug, based on GH and IGF-1 levels, and who tolerate the drug can then be switched to Sandostatin LAR® Depot in the dosage scheme described under Section 2, below (Patients Currently Receiving Immediate Release Sandostatin® Injection) (1).
Acromegaly Dosing Flow Chart
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Patients Currently Receiving Immediate Release Sandostatin® Injection — Acromegaly
Patients currently receiving immediate release Sandostatin® Injection can be switched directly to Sandostatin LAR® Depot in a dose of 20 mg given intramuscularly intragluteally at 4-week intervals for 3 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 (1). At the end of 3 months, Sandostatin LAR® Depot dosage may be continued at the same level or increased or decreased based on the following regimen (1):
- GH <1 ng/mL, and IGF-1 normal, and clinical symptoms controlled: reduce Sandostatin LAR® Depot dosage to 10 mg every 4 weeks (1).
- GH <2.5 ng/mL, and IGF-1 normal, and clinical symptoms controlled: maintain Sandostatin LAR® Depot dosage at 20 mg every 4 weeks (1).
- GH > 2.5 ng/mL, and/or IGF-1 elevated, and/or symptoms not controlled: increase Sandostatin LAR® Depot dosage to 30 mg every 4 weeks (1).
Patients whose GH, IGF-1, and symptoms are not adequately controlled at a dose of 30 mg may have the dose increased to 40 mg every 4 weeks. Doses higher than 40 mg are not recommended (1).
Administration of Sandostatin LAR® Depot at intervals greater than 4 weeks is not recommended because there is no adequate information on whether such patients could be satisfactorily controlled (1).
In patients who have received pituitary irradiation, Sandostatin LAR® Depot should be withdrawn yearly for approximately 8 weeks to assess disease activity. If GH or IGF-1 levels increase and signs and symptoms recur, Sandostatin LAR® Depot therapy may be resumed (1).
Special Populations: Renal Failure — Acromegaly
In patients with renal failure requiring dialysis, the half-life of octreotide may be increased, necessitating adjustment of the maintenance dosage (1).
Patient Monitoring — Acromegaly
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:
- 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.
- 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 the thyroid function (TSH, total and/or free T4) is recommended during chronic octreotide therapy.
Reference
- Sandostatin LAR® Depot (octreotide acetate for injectable suspension) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp.; April 2004.
