Sandostatin LAR Depot Text

Sandostatin^® LAR Depot:
The Only Somatostatin Analogue for the Diarrhea
and Flushing Associated
with Carcinoid Syndrome

This section will highlight some of the clinical findings on Sandostatin^® LAR Depot (octreotide acetate for injectable suspension), including:

• Bioactive Secretions
• Suppression of 5-HIAA Levels
• Reduction in Diarrhea
• Reduction in Flushing Episodes
• The Sandostatin^® Heritage

Excessive Bioactive Secretions Result in Active Symptoms^1,2

• Most prominent symptoms are diarrhea and flushing^2-5
  • Fluid loss from diarrhea may lead to serious health consequences
• Other clinical manifestations include abdominal pain, cardiac lesions, and wheezing⁶
• Uncontrolled bioactive secretions circulate throughout a patient's body—
  elevating 5-HIAA levels—and contribute to the manifestation of symptoms⁷

Sandostatin^® LAR Depot Suppresses 5-HIAA Levels for Effective Management of Symptoms

• A positive correlation between tumor mass and urinary 5-HIAA levels allows for use of 5-HIAA to estimate the extent of carcinoid disease^1,2
• 5-HIAA levels > 150 mg/day predict survival of less than 1 year^1,2
• Sandostatin^® LAR Depot is the only approved drug therapy that works at the site of carcinoid tumors to reduce 5-HIAA levels and control diarrhea and flushing^8,9

Sandostatin^® LAR Depot Reduces Diarrhea Frequency

Sandostatin^® LAR Depot works at tumor sites to control debilitating diarrhea and manage uncomfortable flushing.

• Significantly reduces GI transit time and therefore reduces diarrhea frequency by 42%^8,9
  • Reduction from 4.3 stools/day to 2.5 stools/day
• Sandostatin^® LAR Depot slows GI transit and increases fluid absorption by over 400%¹⁰

Sandostatin^® LAR Depot Reduces Flushing Episodes

• Reduces flushing frequency by 84%^8,9
  • Reduction from 4.5 episodes/day to 0.7 episodes/day

Trust the Sandostatin^® Heritage of Unparalleled Evidence in Treating the Diarrhea and Flushing Associated with Carcinoid Syndrome^11-13

With Sandostatin^®, you can treat with confidence based on unparalleled evidence.

• 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*

Read the full prescribing information (PDF 332KB) for Sandostatin^® LAR Depot.

*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.

References