This section will highlight some of the clinical findings on Sandostatin® LAR Depot, including:
- Bioactive Secretions
- Suppression of 5-HIAA Levels
- Reduction in Severe Diarrhea
- Reduction in Flushing Episodes
- The Sandostatin® Heritage
Excessive Bioactive Secretions Result in Active Symptoms1,2
- Most prominent symptoms are severe diarrhea and flushing2-4
- Fluid loss from severe diarrhea may lead to serious health consequences
- Other clinical manifestations include abdominal pain, cardiac lesions, and wheezing2,5
- Uncontrolled bioactive secretions circulate throughout a patient's body—
elevating 5-HIAA levels—and contribute to the manifestation of symptoms6
Results from the Pivotal Trial: 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 disease1,2
- Sandostatin® LAR Depot works at the site of carcinoid tumors to reduce 5-HIAA levels and control severe diarrhea and flushing associated with carcinoid syndrome7,8
When using Sandostatin®, hypothyroidism may occur. Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) is recommended.
Results from the Pivotal Trial: Sandostatin® LAR Depot Reduces Severe Diarrhea Frequency
Sandostatin® LAR Depot works at tumor sites to reduce debilitating severe diarrhea and manage uncomfortable flushing.
- Significantly reduces GI transit time and therefore reduces severe diarrhea frequency by 42%7,8
- Reduction from 4.3 stools/day to 2.5 stools/day
- Sandostatin® LAR Depot slows GI transit and increases fluid absorption by over 300%9
Results from the Pivotal Trial: Sandostatin® LAR Depot Reduces Flushing Episodes
- Reduces flushing frequency by 84%7,8
- Reduction from 4.5 episodes/day to 0.7 episodes/day
Trust the Sandostatin® Heritage of Unparalleled Evidence in Treating the Severe Diarrhea and Flushing Associated with Carcinoid Syndrome8,10-12
With Sandostatin® LAR Depot and immediate release Sandostatin® Injection, you can treat with confidence based on unparalleled evidence.
- Over 20 years of clinical experience
- Over 800,000 patient-years of experience*
- Over 6000 published articles*
- Over 600 clinical trials*†
- Over 5 million doses of Sandostatin® LAR Depot administered worldwide for all approved indications
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.
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%).
