Overproduction of Growth Hormone

A serious condition with a broad range of symptoms

Acromegaly occurs when the pituitary gland secretes too much growth hormone (GH), resulting in overproduction of insulin-like growth factor-1 (IGF-1) and excessive growth. This hypersecretion of GH often results from the presence of a tumor in the pituitary gland. It is a rare condition, affecting 40 to 60 out of every million people. It is estimated that approximately 15,000 people in the United States have acromegaly, and the condition is typically diagnosed when a patient is between 40 and 50 years of age. Among the many symptoms of acromegaly are gigantism, arthritis, muscle weakness, and cardiovascular abnormalities, some of which can impact life expectancy. Thus, the earlier the diagnosis and treatment, the more likely it is the patient can achieve a better quality of life.

While surgery to completely remove or reduce the size of a tumor is the first-line therapy for acromegaly, this may not be viable for all patients. More than half of the patients who undergo surgical treatment will require further medical therapy. Somatuline® Depot (lanreotide) Injection is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline Depot became available for sale in the United States in November 2007, and is the first and only long-acting acromegaly treatment available in a ready-to-use, prefilled syringe.
Important Safety Information for Somatuline Depot
Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose levels monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60mg.

There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Somatuline Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.

Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline Depot may reduce the intestinal absorption of co-administered drugs. Caution should be used.

The most common adverse reactions (incidence > 5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.

Please see Full Prescribing Information for additional important information.