Indication and Important Safety Information | Full Prescribing Information

Causes of Acromegaly

Insulin like growth factor 1 (IGF-1) and Acromegaly

Acromegaly is caused by high levels of growth hormone in the bloodstream. Typically, acromegaly occurs after the normal growth of the skeleton and other organs of the body is complete. The extra growth hormone also stimulates the liver to produce higher-than-normal amounts of a substance called insulin like growth factor-1 (IGF-1). Together, these two chemicals in the bloodstream cause the symptoms of acromegaly.

What causes high levels of growth hormone?

In the vast majority (95%) of cases of acromegaly, the high levels of growth hormone are caused by a benign tumor on the pituitary gland. The pituitary gland is located just below the brain. It controls the production and release of growth hormone and several other hormones. High levels of growth hormone can also be caused by the tumor itself producing excess growth hormone.

Long-term effects of acromegaly

Even though these tumors are generally not cancerous, they cause harm by causing the symptoms of acromegaly. If left untreated, the symptoms may reduce the life expectancy of a person with acromegaly by up to 10 years.

Acromegaly Symptoms

Typically, acromegaly causes abnormal growth of bones in the body, especially those in the hands and the face. Read about the symptoms of acromegaly.

Acromegaly Diagnosis

Healthcare professionals diagnose acromegaly based on symptoms they can see and on tests to show them what they can't see. Read about the diagnosis of acromegaly.

Acromegaly Treatment Options

Because it has been studied for so long, acromegaly is well understood and can be treated effectively using surgery, medication, and radiation. Read about the treatment options for acromegaly.

Indication and Important Safety Information

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 level 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 60 mg.

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 coadministered drugs. Caution should be used.

The most common adverse reactions (incidence >5%) are diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), flatulence (7%), arthralgia (7%), and loose stools (6%).

For Full Prescribing Information, click here.