Octreotide—the active ingredient in Sandostatin® LAR Depot (octreotide acetate for injectable suspension) has been studied for 20 years in over 600 clinical trials, and has been reviewed in more than 6000 articles. Sandostatin® LAR is the number 1 prescribed somatostatin analogue in the world. It offers you the confidence of a medical therapy that is time tested and has a well-studied safety and efficacy profile. These are some of the reasons you can feel confident in your treatment with Sandostatin® and Sandostatin® LAR Depot.
What Is Sandostatin® Injection?
Sandostatin® (octreotide acetate) Injection is an analogue of somatostatin, a natural hormone that is a powerful inhibitor of growth hormone. It can treat symptoms of carcinoid syndrome, flushing and diarrhea. This injection is usually administered 2 or 3 times a day subcutaneously (just under the skin surface) by the patient. Patients are usually started on this formulation for 2 weeks to see if they can tolerate the drug. They then progress to Sandostatin® LAR Depot.
Sandostatin® is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
Sandostatin® is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Read the full prescribing information for Sandostatin® Injection, and see important information about Sandostatin® Injection.
What Is Sandostatin® LAR Depot?1,5
Sandostatin® LAR Depot is a somatostatin analogue administered by your healthcare professional every 28 days. Sandostatin® LAR Depot is a different preparation of immediate release Sandostatin® Injection. "LAR" stands for long acting release. Sandostatin® LAR Depot is a medical therapy with over 10 years of clinical experience and over 4 million doses have been administered worldwide.*Because you receive it only every 28 days, Sandostatin® LAR Depot may have a significant impact on simplifying the management of your care.
*Combined use of immediate release Sandostatin® Injection and Sandostatin® LAR Depot for all approved indications.
Sandostatin® LAR Depot is indicated for long-term maintenance therapy in patients with acromegaly and in the treatment of diarrhea and flushing related to carcinoid syndrome and VIPomas.
Read the full Prescribing Information for Sandostatin® LAR Depot, and see important information about 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. 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.
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.
