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For the long-term treatment of adult patients with acromegaly who had inadequate response to or cannot be treated with surgery and/or radiotherapy1




Primary endpoint at Week 4

  • 63% of Somatuline Depot patients (52/83) achieved >50% decrease of growth hormones vs 0% of placebo patients (0/25) (P<0.001)

Efficacy achieved in the first 16 weeks was maintained through 52 weeks*1,2

Patients experienced a >50% decrease in GH across all doses

  • 82% of patients experienced >50% reduction in GH at Week 52 (81/99)*

Study design: In a 1-year study including a 4-week, double-blind, placebo-controlled phase (N=107); After Week 4, all patients received active drug and entered a 16-week, single-blind, fixed-dose phase (N=105) and a 32-week, open-label, dose-titration phase (N=99) injections of 60, 90, or 120 mg were given at 4-week intervals. During the dose-titration phase of the study, the dose was titrated twice, if needed, according to individual GH and IGF-1 levels.

*Week 16 and Week 52 data were secondary endpoints in the pivotal trial.2
P value is vs placebo.
Week 4 data were a primary endpoint in the pivotal trial.2

IGF-1 Normalization Responders§

  • 59% of patients experienced IGF-1 normalization at Week 52 (57/99)§

§IGF-1 data analyses were secondary endpoints of the pivotal trial.


Somatuline Depot was the first somatostatin analog (SSA) to offer FDA-approved EDI for controlled patients†1,3

In an open-label, uncontrolled, multicenter, phase 3 trial3

Biochemical control was maintained with 120-mg dosing administered once every 6 or 8 weeks3

Controlled is defined as GH level from >1.0 ng/mL to ≤2.5 ng/mL, normalized IGF-1 level, and satisfactory management of clinical symptoms as determined by the healthcare professional.

Patients who are controlled with Somatuline Depot 60 mg or 90 mg administered every 4 weeks can be considered for treatment with 120 mg administered every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response. Continued monitoring of patients’ response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

Study design: In an open-label, comparative, multicenter, phase 3 trial, Somatuline Depot (lanreotide) Injection 120 mg was administered every 4, 6, or 8 weeks in patients previously receiving lanreotide microparticles every 5-7, 8-11, or 12-16 days, respectively. Of patients whose levels were controlled (GH ≤2.5 ng/mL and normalized IGF-1) when switched to extended dosing intervals (n=32), 5 out of 6 remained controlled after 3 injections at 6-week intervals and 23 out of 26 remained controlled after 3 injections at 8-week intervals.

Pharmacokinetic Profile



Cmin of lanreotide after a single deep subcutaneous injection in healthy volunteers (mean ± SD)


Study design: In a phase 1, single-center, open-label, randomized, parallel-group study, the pharmacokinetic profile of a single injection of lanreotide was assessed in healthy volunteers at a dose of 120 mg (n=12) through 56 days (8 weeks).

In patients treated with Somatuline Depot 120 mg:

  • Serum concentration (Cmin) through 6- and 8-week dosing intervals3

Study design: In open-label, comparative, multicenter, phase 3 trials, eligible patients who responded to SSAs received 3 to 5 injections of Somatuline Depot 120 mg. Somatuline Depot 120 mg was injected every 4, 6, or 8 weeks in patients previously receiving lanreotide microparticles every 5-7, 8-11, or 12-16 days, respectively. There was no washout period or dose titration.



  • SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

Warnings and Precautions

  • Cholelithiasis and Gallbladder Sludge
    • SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation.
    • Periodic monitoring may be needed.
    • If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately.
  • Hypoglycemia or Hyperglycemia
    • Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
    • Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
  • Cardiovascular Abnormalities
    • SOMATULINE DEPOT may decrease heart rate.
    • In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension.
    • In patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia.
    • In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
  • Thyroid Function Abnormalities
    • Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients.
    • Thyroid function tests are recommended where clinically appropriate.
  • Monitoring/Laboratory Tests: In acromegaly, serum GH and IGF-1 levels are useful markers of the disease and effectiveness of treatment.

Most Common Adverse Reactions 

  • Acromegaly: Adverse reactions in >5% of patients who received SOMATULINE DEPOT were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%) injection-site reactions (9%) constipation (8%) flatulence (7%) vomiting (7%) arthralgia (7%) headache (7%) and loose stools (6%).
  • GEP-NETs: Adverse reactions in >10% of patients who received SOMATULINE DEPOT were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).
  • Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions in ≥5% of patients who received SOMATULINE DEPOT and at least 5% greater than placebo were headache (12%), dizziness (7%) and muscle spasm (5%).

Drug Interactions

  • SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).

Special Populations

  • Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
  • Moderate to Severe Renal and Hepatic Impairment: See full prescribing information for dosage adjustment in patients with acromegaly.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.


SOMATULINE® DEPOT (lanreotide) is a somatostatin analog indicated for:

  • the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
  • the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
  • 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 in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.

Please see accompanying full Prescribing Information and Patient Information.