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GEP-NETs & Carcinoid Syndrome Site
Visit the Patient Site

EFFICACY

SOMATULINE® DEPOT: MAINTAINED REDUCTION OF GH AND NORMALIZATION OF 
IGF-11

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

Efficacy in the 1-year pivotal trial1,2

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, or placebo, 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.1
PRIMARY
ENDPOINT
The primary efficacy endpoint was the proportion of patients with a >50% reduction in mean GH levels from baseline to Week 4.2
  • Primary data: 4-week, double-blind, placebo-controlled phase1
    • 63% of Somatuline® Depot patients (52/83) achieved >50% decrease of GH vs 0% of placebo patients (0/25)2
SECONDARY
ENDPOINTS
Secondary efficacy endpoints included the effect of repeated Lan-Autogel injections on GH and IGF-1 levels at specific time points: the proportions of patients with >50% reduction in GH from baseline, GH ≤2.5 ng/mL, or normalized IGF-1 or both normalized IGF-1 and GH ≤2.5 ng/mL. The assessment of acromegaly symptoms between baseline and Weeks 4, 16, 32, and 52, or the end of the study, was also an endpoint.2
  • Secondary data: 16-week, single-blind, fixed-dose phase1
    • At Week 16, 72% of patients had a >50% reduction in GH levels from baseline1
    • Efficacy achieved in the first 16 weeks was maintained through 52 weeks1
    • 82% of patients experienced >50% reduction in GH at 
      Week 52 (81/99)2

Percentage of patients who achieved a >50% decrease in growth hormones (GH)1,2

Adverse reactions in >5% of patients who received Somatuline® Depot were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), and injection-site reactions (9%).1

Please also see the trial study design above and Patient Information below.

Learn about Somatuline Depot safety

IGF-1 normalization responders1,2

  • Primary data:
    • 25% of patients had normal IGF-1 levels after one injection2
  • Secondary data:
    • 54% of patients experienced IGF-1 normalization at Week 161
    • 59% of patients experienced IGF-1 normalization at Week 522

Percentage of patients who experienced IGF-1 normalization responders1,2

Additional data

Extended dosing intervals (EDIs)1,3

Somatuline Depot was the first somatostatin analog (SSA) to offer FDA-approved EDI for controlleda patients1,3b

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

aControlled 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.1

bPatients 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.1

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.3,4 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.3,5

Pharmacokinetic (PK) profile during EDIs6

Serum concentration (Cmin) of lanreotide after a single deep subcutaneous injection in healthy volunteers (mean ± SD)6

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).7

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.3,4

Learn about Somatuline Depot safety

FDA=Food and Drug Administration; GH=growth hormone; IGF-1=insulin-like growth factor 1; SD=standard deviation; SSA=somatostatin analog.

REFERENCES:
  • Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc; July 2024.
  • Melmed S, Cook D, Schopohl J, et al. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28.
  • Data on file. Ipsen Group. Serum Flashcard.
  • Lucas T, Astorga R; Spanish–Portuguese Multicentre Autogel Study Group on Acromegaly. Efficacy of lanreotide Autogel® administered every 4–8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial. Clin Endocrinol (Oxf). 2006;65:320-326.
  • Gomez-Panzani E, Chang S, Ramis J, et al. Sustained biochemical control in patients with acromegaly treated with lanreotide depot 120 mg administered every 4 weeks, or an extended dosing interval of 6 or 8 weeks: a pharmacokinetic approach. Res Rep Endocr Disord. 2012;2:79-84.
  • Data on file. Ipsen Group. 2.7.2 Summary of Clinical Pharmacology Studies.
  • Trocóniz IF, Cendrós JM, Peraire C, et al. Population pharmacokinetic analysis of lanreotide Autogel in healthy subjects: evidence for injection interval of up to 2 months. Clin Pharmacokinet. 2009;48(1):51-62.

IMPORTANT SAFETY INFORMATION & INDICATION

Contraindications

  • 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.
  • Steatorrhea and Malabsorption of Dietary Fats
    • New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including SOMATULINE DEPOT. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss.
    • If new occurrence or worsening of these symptoms are reported in patients receiving SOMATULINE DEPOT, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

Most Common Adverse Reactions

  • 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%).

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.

INDICATIONS

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

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All rights reserved. October 2025. SMD-US-002663