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For Patients With Acromegaly

Sandostatin® LAR Depot

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 b

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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 pa
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Sandostatin® LAR Depot

Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is a medical treatment for acromegaly in patients who have responded and tolerated Sandostatin® Injection (octreotide acetate). Both Sandostatin® LAR Depot and Sandostatin® Injection (octreotide acetate) are known as somatostatin analogues, and may reduce both growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels.

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Acromegaly

The term "acromegaly" comes from the Greek words "acro" (extremities) and "megaly" (enlargement). As the name suggests, acromegaly can be recognized by abnormal growth of the hands and feet, as well as other signs such as enlargement of the facial features. However, acromegaly also involves changes in the way the body functions. These health risks make it important to attain and maintain control of the condition once it has been diagnosed.

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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 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.

Please see full Prescribing Information.

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.

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.