In this section, you'll find the following information about dosing Sandostatin® LAR Depot:
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, for acromegaly patients
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 delivery1,3
Achieve Optimal Responses Through Proper Monitoring and Dose Titration1
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 intervals2.
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 not recommended 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, please follow the recommendations printed below2.
Patients Not Currently Receiving Sandostatin®
Patients not currently receiving Sandostatin® 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 irritation2.
Although responsiveness of GH to Sandostatin® can be ascertained quickly, patients should be maintained on immediate-release Sandostatin® Injection for at least 2 weeks to determine tolerance to octreotide2.
The most common adverse events are gastrointestinal, which usually begin within the first few days of administration. 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)2.
INDICATIONS AND USAGE
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated for:
- Long-term maintenance therapy in acromegalic patients who have had 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).
- Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
- Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.
In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
- Gallbladder abnormalities may occur: Patients should be monitored periodically.
- Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be monitored when Sandostatin LAR Depot treatment is initiated or when the dose is altered. Antidiabetic treatment should be adjusted accordingly.
- Thyroid Function: Hypothyroidism may occur. Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) is recommended.
- Cardiac Function: Bradycardia, arrhythmia, conduction abnormalities, and other EKG changes may occur. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac disease. Use with caution in at-risk patients.
- Nutrition: Octreotide may alter absorption of dietary fats. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin LAR Depot. Patients on total parenteral nutrition (TPN) and octreotide should have periodic monitoring of zinc levels.
Drug Interactions: The following drugs require monitoring and possible dose adjustment when used with Sandostatin LAR Depot: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, bromocriptine. Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should be used with caution.
Adverse Reactions: The most common adverse reactions occurring in patients receiving Sandostatin LAR Depot are:
- Acromegaly: biliary abnormalities (52%), diarrhea (36-48%), cholelithiasis (13-38%), abdominal pain or discomfort (11-29%), flatulence (26%), influenza-like symptoms (20%), constipation (19%), headache (15%), anemia (15%), hyperglycemia (15%), injection site pain (2-14%), hypertension (13%), dizziness (12%), fatigue (11%), nausea (10%), vomiting (7%), hypothyroidism (2%), hypoglycemia (2%), and goiter (2%).
- Carcinoid Tumors and VIPomas: biliary abnormalities (62%), injection site pain (20-50%), nausea (24-41%), abdominal pain (10-35%), fatigue (8-32%), headache (16-30%), hyperglycemia (27%), back pain (8-27%), constipation or vomiting (15-21%), dizziness (18-20%), sinus bradycardia (19%), pruritus (18%), URTI (10-18%), myalgia (4-18%), flatulence (9-16%), arthropathy (8-15%), rash (15%), generalized pain (4-15%), sinusitis (5-12%), conduction abnormalities (9%), hypoglycemia (4%), and arrhythmia (3%).
