Indication and Important Safety Information | Full Prescribing Information

Somatuline® Depot (Lanreotide) Injection

Somatuline® Depot (lanreotide) Injection is a medication for the treatment of acromegaly that may lower the levels of excess growth hormone and insulin-like growth factor in your body. Both of these effects may help your body control acromegaly.

Somatuline Depot is a “somatostatin analog.” Somatostatin is a natural substance that helps control the amount of growth hormones and factors your body produces. While Somatuline® Depot (lanreotide) Injection is part of the somatostatin analog group of medications and works the same way, it is different from other analogs, and the differences are simple.

Worldwide Marketing: Somatuline Autogel & Lanreotide Autogel

The FDA approved Somatuline® Depot (lanreotide) Injection based on randomized controlled clinical trials. In addition, this product has extensive commercial experience worldwide, as Somatuline Autogel or Lanreotide Autogel, and in 2006, more than 6000 patients were treated.

Somatuline® Depot (Lanreotide) Injection is easy for you to take

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 (lanreotide) Injection is the only long-acting somatostatin analog that can be injected under the skin instead of into the muscle.
  • No-mixing-needed. Somatuline® Depot (lanreotide) Injection 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 (lanreotide) Injection 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 (lanreotide) Injection is just half a milliliter (1/10 of a teaspoon). That’s 80% less than other long-acting somatostatin analogs. The smaller the injection, the less chance it might hurt.

Who should take Somatuline® Depot (lanreotide) Injection?

Last year it helped over 6000 people with acromegaly. See who should take Somatuline® Depot (lanreotide) Injection.

How does Somatuline® Depot (lanreotide) Injection work?

By mimicking a natural hormone, it helps your body control acromegaly. Learn more about how Somatuline® Depot (lanreotide) Injection works.

How to take Somatuline® Depot (lanreotide) Injection

Somatuline Depot is injected in a simple, easy injection process. Learn more about how easy it is to inject 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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