Indication and Important Safety Information | Full Prescribing Information
Powerful, long-term efficacy

Drive down elevated IGF-1 and GH levels

In two studies, Somatuline® Depot (lanreotide) Injection demonstrated proven reductions in IGF-1 and GH levels.

At the end of studies 1 and 2, there was an overall reduction in IGF-1 and GH levels.1*

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Go for normalized IGF-1 and GH levels

58% of patients had normalized IGF-1 levels at the end of 52 weeks.1*

In addition, 69% of patients had GH levels ≤5.0 ng/mL at the end of study.1*

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* Study 1: A 52-week study of 108 patients with acromegaly. Qualified patients were randomized to receive a single deep subcutaneous injection of placebo or Somatuline® Depot (lanreotide) Injection 60 mg, 90 mg, or 120 mg, followed four weeks later by a fixed-dose phase where they received four injections of Somatuline® Depot (lanreotide) Injection, and ending in a dose-titration phase where they received eight injections of Somatuline® Depot (lanreotide) Injection. Injections were given at four-week intervals, and during the dose-titration phase, the dose was titrated twice (every fourth injection), as needed, according to individuals GH and IGF-1 levels. 99 patients completed the dose-titration phase of the study. Final values were calculated by carrying forward the last observation from the 107 patients that participated in the dose-titration phase.
Study 2: A 48-week open-label, uncontrolled multicenter study that enrolled 63 patients who had an IGF-1 concentration ≥1.3 times the upper limit of the age-adjusted normal range. In the fixed-dose phase, patients received four deep subcutaneous injections of Somatuline® Depot (lanreotide) Injection 90 mg at four-week intervals. Patients then entered a dose-titration phase where the dose of Somatuline® Depot (lanreotide) Injection was adjusted based on GH and IGF-1 levels at the beginning of the dose-titration phase and, if necessary, again after another four injections. Patients titrated up to the maximum dose (120 mg) were not allowed to titrate down again. 57 patients completed the dose-titration phase of the study. Final values were calculated by carrying forward the last observation from all 63 patients.

 

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.

 
 

Safety and tolerability of Somatuline® Depot (lanreotide) Injection

Somatuline® Depot (lanreotide) Injection is well-tolerated and had a 1.9% discontinuation rate in a 52-week study.1,2 Learn more about the safety and tolerability of 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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