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 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 no 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.

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