Approved Use
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: Treatment with Sandostatin LAR Depot may affect gallbladder function, with postmarketing reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; and nutritional absorption, which may require monitoring by your doctor. Call your doctor if you experience signs or symptoms of gallstones or any of their complications.
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 carcinoid 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.
Please see full Prescribing Information.
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