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. Deltoid injections should be avoided due to significant discomfort at the injection site when given in that area.
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.
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
- Patient Monitoring
Dosing Flow Chart
*For patients with carcinoid tumors, starting doses of immediate-release Sandostatin® (octreotide acetate) Injection range from 100 to 600 mcg/day in 2 to 4 divided doses. For patients with VIPomas, starting dosages range from 200 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® Injection
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. 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.
Dosages higher than 30 mg are not recommended.
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.
Special Populations:
Renal Failure
In patients with renal failure requiring dialysis, the starting dose 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).
Hepatic Impairment—Cirrhotic Patients
In patients with established cirrhosis of the liver, the starting dose should be 10 mg every 4 weeks.
Patient Monitoring
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
- TSH, total and/or free T4
- In patients with acromegaly: GH, IGF-1
- In patients with carcinoid syndrome: 5-HIAA, plasma serotonin, and plasma substance P
- In patients receiving TPN: serum zinc concentrations
Read the Prescribing Information for Sandostatin® LAR Depot
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%).
