Simplifying Treatment

A convenient, effective way to treat acromegaly

Somatuline® Depot (lanreotide) Injection is the only long-acting
somatostatin analog with:
  • Under-the-skin injections. Another long-acting somatostatin analog is delivered by injection into muscle, which can be painful. Somatuline® Depot is the only long-acting somatostatin analog that can be injected under the skin instead of into the muscle.
  • No-mixing-needed. Somatuline® Depot does not need to be mixed before injecting, unlike other long-acting medications for acromegaly. It comes in a single, ready-to-use, prefilled syringe.
  • Simple injection. Injecting Somatuline® Depot is an easy procedure. The syringe has a shorter needle than the one used to inject the other long-acting somatostatin analog.
  • Easy-to-take. An injection of Somatuline® Depot is just half a milliliter (1/10 of a teaspoon). That's 80% less than other long-acting somatostatin analog. The smaller the injection, the less chance it might hurt.
Somatuline® Depot 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. The goal of treatment is to reduce growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels to normal.

Long-acting lanreotide is marketed under the name Somatuline® Autogel® outside of the United States by Tercica's partner, Ipsen SA. During 2006, more than 7,000 patients in 60 countries used this medication. In August 2007, Ipsen SA received notice of approval from the U.S. Food and Drug Administration (FDA) for marketing Somatuline® Depot in the United States. To learn more about this new treatment option for acromegaly, visit the Somatuline® Depot website.
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.