Sandostatin

Understanding
Acromegaly

This page gives basic information you need to begin understanding acromegaly, including:

What is acromegaly?

The name "acromegaly" comes from the Greek words for extremities and enlargement. Acromegaly is a rare disease that causes gradual physical changes, often over many years. Acromegaly is a condition that results from too much growth hormone being released into the body. Unlike the flu or a common cold, you will not notice symptoms immediately. Acromegaly usually affects middle-aged adults and is considered a chronic disease. Because the symptoms of acromegaly develop slowly over time, the diagnosis can often be delayed, sometimes for up to a decade.1,2

What causes acromegaly?

Acromegaly is generally caused by a noncancerous growth called a tumor or an adenoma located on the pituitary gland. The pituitary gland is a pea-sized structure located in the front of the brain, behind the eyes (see figure below). It is also commonly referred to as the master gland of the body. The pituitary gland secretes many hormones, such as growth hormone (GH), that control growth, metabolism, and reproductive activity. In acromegaly, the pituitary tumor secretes a high level of GH, causing the enlargement of many body parts, such as the hands and feet. Because of where it is located, this tumor can also cause headaches with pressure behind the eyes.1,3,4

Important hormones that are affected by a pituitary tumor include:

  • Growth hormone (GH)1,3
    • GH is made in the pituitary gland (see figure below)
    • In a person with acromegaly, too much GH is released into the body
    • Overproduction of GH causes changes in physical appearance and body function1,3
  • Insulin-like growth factor 1 (IGF-1)1,3,5
    • Levels of IGF-1 (made mostly in the liver) rise when GH levels rise
    • Many signs and symptoms of acromegaly are caused when both GH and IGF-1 are elevated together

Many signs and symptoms of acromegaly are caused when both GH and IGF-1 are elevated together

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.

References

(1) National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, US Department of Health and Human Services Web site. Acromegaly. Available at: www.endocrine.niddk.nih.gov/pubs/acro/acromegaly.pdf. Accessed August 12, 2008.

(2) Molitch ME. Clinical manifestations of acromegaly. Endocrinol Metab Clin North Am.1992;21:597-614.

(3) Barkan AL. Acromegaly. Diagnosis and therapy. Endocrinol Metab Clin North Am. 1989;18:277-310.

(4) University of Maryland Medical Center Web site. Endocrinology health guide: the pituitary gland. Available at http://www.umm.edu/endocrin/pitgland.htm. Accessed December 7, 2009.

(5) Daughaday WH, Starkey RH, Saltman S, et al. Characterization of serum growth hormone (GH) and insulin-like growth factor I in active acromegaly with minimal elevation of serum GH. J Clin Endocrinol Metab. 1987;65:617-623.

Important Safety Information

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