This section will highlight some of the clinical findings on Sandostatin® LAR Depot (octreotide acetate for injectable suspension), including:
- Achieving Impressive Tumor Shrinkage
- Achieving Powerful Biochemical Control
- The Unmatched Sandostatin® Heritage
Achieving Impressive Tumor Shrinkage
Sandostatin® LAR Depot demonstrated tumor shrinkage* in 2 open-label studies (N=143)1
- 20% median reduction in tumor volume at Week 24 (N=143)1
- 36% median reduction in tumor volume at Week 48 (n=94)1
The majority of patients had impressive tumor volume reduction (>20%) (N=68)2
- No patients in this study were found to have increased tumor volume†2
- >20% shrinkage of tumor volume occurred in:
- 63% of all patients at 24 weeks (N=68)
- 75% of all patients at 48 weeks (N=68)
- A subanalysis revealed >20% shrinkage in:
- 100% of patients with microadenomas (n=8)
- Approximately 70% of patients with macroadenomas (n=60)
*Shrinkage is defined as >20% reduction from initial tumor volume.
†Outside the ±20% measurement area.
Achieving Powerful Biochemical Control
Evaluated in 3 clinical trials, Sandostatin® LAR Depot delivers control of both GH and IGF-1 levels:
- Up to 68% of patients experienced both GH <2.5 ng/mL + IGF-1 normalization1,3
*Range reflects results derived from pivotal trials and long-term follow-up data.
- Up to 75% of patients experienced IGF-1 normalization1,3
Achieving Steady State Drug Release—The Somatostatin Analogue with a Smooth PK Profile
Provides consistent management of drug levels, dose to dose:
Sandostatin® LAR Depot is the only somatostatin analogue that releases drug via biodegradable microspheres—the technology behind its long-acting properties. The microspheres slowly release octreotide from the site of injection, so that therapeutic drug levels are maintained from one monthly dose to the next.
- Sandostatin® LAR Depot maintains optimal drug levels over a 28-day cycle4
The Unmatched Sandostatin® Heritage
Trust the Sandostatin® Heritage and Tolerability5,6,7
With Sandostatin®, you can treat with confidence based on unparalleled evidence5,6.
- 20 years of clinical experience*
- Over 600,000 patient-years of experience*
- Over 6000 published articles*
- Over 600 clinical trials*†
- Over 4 million doses of Sandostatin® LAR Depot administered worldwide†5
*Combined use of immediate release Sandostatin® Injection and Sandostatin® LAR Depot for all approved indications.
†Includes both ongoing and completed trials for all approved indications.
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.
