This section will highlight some of the clinical findings on Sandostatin® LAR Depot, including:
Unmatched Sandostatin® Evidence
Trust the Sandostatin® Heritage and Tolerability1,2
With Sandostatin®, you can treat with confidence based on unparalleled evidence1-4.
- 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
*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.
Achieve Powerful Biochemical Control
As recorded in the 3 registration trials, Sandostatin® LAR Depot delivers control of both GH and IGF-1 levels:
*Ranges reflect results derived from pivotal trials and long-term, follow-up data.
Achieve steady state drug release—the somatostatin analogue with a smooth PK profile
Provide consistent management of drug levels, dose to dose:
Sandostatin® LAR Depot releases drug via biodegradable microspheres—the technology behind its long-acting properties. This unique microsphere technology slowly release octreotide from the site of injection, so that therapeutic drug levels are maintained from one monthly dose to the next3.
- Sandostatin® LAR Depot maintains optimal drug levels over a 28-day cycle6
Clinical Data Supporting Median Reductions in Tumor Volume†
Sandostatin® LAR Depot demonstrated median reductions in tumor volume in previously untreated acromegaly patients in 2 independent, open-label studies3.
In one study (n=94)3:
- 25% median reduction in tumor volume at Week 24
- 36% median reduction in tumor volume at Week 48
In another study (n=49)3:
- 21% median reduction in tumor volume at Week 24
- No patients experienced an increase in tumor volume while on treatment with Sandostatin® LAR Depot outside the ±20% measurement area7
- Sandostatin® LAR Depot is not indicated for tumor shrinkage
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%).
