All FDA-approved drugs have what is known as prescribing information—a document that provides a comprehensive listing of information doctors need to know in order to safely and effectively prescribe the drug. This includes information on which conditions the drug has been approved to treat, its efficacy, possible side effects, drug interactions, precautions and warnings for certain patients, dosing and administration, and a detailed list of ingredients.
Although the prescribing information is intended for healthcare providers, there is no better source for detailed information about FDA-approved drugs. For this reason, patients who want more detailed clinical information will often consult the prescribing information.
Prescribing Information for Sandostatin® LAR Depot (octreotide acetate for injectable suspension)
The safety and efficacy of Sandostatin® LAR Depot (octreotide acetate for injectable suspension) for treating acromegaly, severe diarrhea and flushing associated with carcinoid syndrome, and VIPomas was established in clinical trials. Keep in mind as well that Sandostatin® LAR Depot is a reformulation of a trusted, reliable treatment —Sandostatin®. Immediate-release Sandostatin® (octreotide acetate) Injection has been used worldwide for over 20 years in thousands of patients. Both share the same active ingredient, octreotide acetate.
Read the full Prescribing Information for Sandostatin® LAR Depot.
Read the full Prescribing Information for immediate release Sandostatin® Injection.
INDICATIONS AND USAGE
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is a prescription medicine 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: Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor.
Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.
Common side effects: Most patients experience side effects at some time. Some common side effects you may experience include:
- Acromegaly: diarrhea, gallstones, abdominal pain, and flatulence
- Carcinoid tumors: back pain, fatigue, headache, abdominal pain, nausea, and dizziness
Other information: Patients with carcinoids tumors and VIPomas should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.
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.
