Indication and Important Safety Information | Full Prescribing Information
Epidemiology and pathophysiology of acromegaly

Epidemiology of acromegaly

Acromegaly is a rare condition, occurring in 40 to 60 per million people. It has a low incidence of 3 to 4 new cases/year/million inhabitants, with as many as 1,500 new cases occurring each year.5

In the United States, between 15,000 and 27,000 patients have acromegaly. Acromegaly occurs with the same frequency in men and in women.

A diagnosis of acromegaly is generally made when the patient is between 40 and 50 years old. The diagnosis is also often made late; on average, 9 years after the onset of the first symptoms.6

As with many chronic conditions, early diagnosis and treatment are essential to improved outcomes. In patients with acromegaly, life expectancy may be reduced by 10 years, and mortality is two- to four-fold that of the general population.6,7

Pathophysiology of acromegaly

Acromegaly is caused by the hypersecretion of growth hormone (GH), which stimulates hepatic production of insulin-like growth factor-1 (IGF-1). While GH produces some of its somatic effects directly, others are mediated by IGF-1.6

In 95% of cases, acromegaly is due to pituitary adenomas, which generally grow slowly over several years.6 Pituitary tumors account for 15% of all intracranial tumors.8

In 90% of cases of acromegaly, the adenoma is made up of cells that secrete only GH. Of the remaining tumors, 25% secrete GH and prolactin, while other tumors secrete GH and different pituitary hormones.8

 

Read about symptoms and diagnosis.

The symptoms of acromegaly can surface in various systems. Learn more about the clinical effects of acromegaly, and the biochemical evidence used to diagnose acromegaly.

 

How to inject Somatuline® Depot (lanreotide) Injection

Somatuline® Depot (lanreotide) Injection is injected in an easy, two-step injection process.1 Learn more about injecting Somatuline® Depot (lanreotide) Injection.

 

Who should take Somatuline® Depot (lanreotide) Injection

Somatuline® Depot (lanreotide) Injection is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation. It is also for patients who cannot tolerate surgery or radiation.1 Find out more about who should take Somatuline® Depot (lanreotide) Injection.

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%).

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