Indication and Important Safety Information | Full Prescribing Information

Somatuline Depot (lanreotide) Injection - Simple, effective acromegaly treatment

Somatuline® Depot (lanreotide) Injection for acromegaly treatment

Acromegaly occurs when the pituitary gland in your body creates too much of substances known as growth hormone and growth factors. Somatuline® Depot (lanreotide) Injection is a medical treatment for acromegaly that decreases the effects of those substances and helps your body control acromegaly.

Somatuline® Depot (lanreotide) Injection is different from other medical treatments for acromegaly, and the difference is a single, ready-to-use, prefilled syringe with a simple, easy injection procedure.

Learn more about treating acromegaly with 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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Recently Diagnosed with Acromegaly Currently Treated for Acromegaly Currently on Somatuline Depot