Sandostatin LAR Depot Text

Dosing
Sandostatin^® LAR Depot

In this section, you'll find the following information about dosing Sandostatin^® LAR Depot (octreotide acetate for injectable suspension):

• Optimal Dosing for Optimal Management
• Proper Monitoring and Dose Titration

Optimal Dosing for Optimal Management of Acromegaly

The efficacy your patients need may not be demonstrated if the drug is not dosed as indicated.

• The starting dose of Sandostatin^® LAR Depot is 20 mg
• Sandostatin^® LAR Depot can be titrated up to 40 mg, if needed

Dosing as indicated typically results in:

• Maximal dose-related GH suppression achieved and maintained at 3 months¹
• Maximal dose-related IGF-1 suppression achieved and maintained at 6 months¹
• Steady-state drug levels at 3 months²
• Steady PK levels that may ensure consistent drug delivery³

Achieve Optimal Responses Through Proper Monitoring and Dose Titration²

Dose Flow Chart

Sandostatin^® LAR Depot must be administered by a trained healthcare provider. 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 IV or subcutaneous route. There is no direct relationship between dosage of immediate release Sandostatin^® Injection and dosage of Sandostatin^® LAR Depot. When beginning treatment with Sandostatin^® LAR Depot, please follow the recommendations printed below.

Patients Not Currently Receiving Octreotide Acetate

Patients not currently receiving octreotide acetate should begin therapy with immediate release Sandostatin^® 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 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 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 irritation¹.

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 octreotide¹.

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 GI symptoms¹. 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 the section below (Patients Currently Receiving Immediate Release Sandostatin^® Injection)¹.

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.

References