Here's What You Need to Know
About the Supply and Storage of
Sandostatin® LAR Depot.
On this page:
Supply
For convenient dose titration, Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is available in 3 strengths delivering 10 mg, 20 mg, or 30 mg of octreotide acetate. Each package is a single-use kit, and is clearly marked with the dosage strength and a color that differentiates it from the other strengths:
 |
10 mg Sandostatin® LAR Depot (dark blue package) NDC 0078-0340-61 |
 |
20 mg Sandostatin® LAR Depot (orange package) NDC 0078-0341-61 |
 |
30 mg Sandostatin® LAR Depot (dark red package) NDC 0078-0342-61 |
Before prescribing Sandostatin® LAR Depot you should refer to the full
Prescribing Information. Please note that general dosage guidelines
recommend beginning with the 20-mg dose.
Also, before administering the product, check the package to see that the required contents are intact. Each package of Sandostatin® LAR Depot should contain:
- One vial containing Sandostatin® LAR Depot
- One diluent-filled syringe
- Two 1 1/2", 19-gauge needles
- Two alcohol wipes
- Instruction booklet
Do not substitute syringes or needles other than the sizes specified.
Storage
Prolonged storage of Sandostatin® LAR Depot requires refrigeration. Store at temperatures of 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Prior to using Sandostatin® LAR Depot, remove the product package from refrigeration and allow the product to reach room temperature. This may take from 30 to 60 minutes. Remember, however, that after preparation of the suspension, the drug must be administered immediately.
Caution: Sandostatin® LAR Depot must be protected from high temperatures. This may include temporary storage areas that become hot, such as warehouses or car interiors. Because octreotide acetate is uniformly distributed within microspheres made of a biodegradable polymer, temperatures above 41°C (105°F) will cause the product to melt. If Sandostatin® LAR Depot reaches 41°C (105°F), it will be impossible to achieve suspension of the powder in the diluent and the product must be discarded. If this occurs, please call the Sandostatin® Therapy Support Hotline at 1-877-LAR-HELP.
Note: Rubber stoppers contained in this package contain latex.
Learn about preparation and administration of 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.
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.
