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FDA-approved for 
PFS in patients with GEP-NETs and to control carcinoid syndrome in appropriate patients

Somatuline® Depot is a somatostatin analog (SSA) indicated to improve progression-free survival (PFS) in gastroenteropancreatic 
neuroendocrine tumors (GEP-NETs) and proven to reduce the need for rescue medication in carcinoid syndrome in appropriate patients.1,2

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Patients and other individuals portrayed throughout this website are actors.

INDICATIONS
Somatuline® Depot (lanreotide) is a somatostatin analog indicated for:1

  • the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs to improve progression-free survival; and
  • the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy

It is not known if Somatuline Depot is safe and effective in children.

FDA=Food and Drug Administration; GEP-NET=gastroenteropancreatic neuroendocrine tumor;
PFS=progression-free survival; SSA=somatostatin analog.

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FDA-approved for PFS in patients with GEP-NETs and to control carcinoid syndrome in appropriate patients

Somatuline® Depot is a somatostatin analog (SSA) indicated to improve progression-free survival (PFS) in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and proven to reduce the need for rescue medication in carcinoid syndrome in appropriate patients.1,2

INDICATIONS

Somatuline® Depot (lanreotide) is a somatostatin analog indicated for:1

  • the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs to improve progression-free survival; and
  • the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy

It is not known if Somatuline Depot is safe and effective in children.

FDA=Food and Drug Administration; GEP-NET=gastroenteropancreatic neuroendocrine tumor;
PFS=progression-free survival; SSA=somatostatin analog.

LET’S CHAT. Request an in-office visit chatbox.png

Patients and other individuals portrayed throughout this website are actors.

WHY SOMATULINE DEPOT IS A CHOICE FOR TREATMENT INITIATION1-4

PROVEN FOR PFS IN GEP-NETS1,2
Studied in multiple tumor locations
including the pancreas for PFS

A PROLONGED-RELEASE
FORMULATION1,4
Learn more about the pharmacokinetic
profile and onset of action

PROVEN IN CARCINOID SYNDROME1,3
See the results for the reduced need
for rescue medication

IPSEN CARES
A central support system for eligible patients. Find out more

A READY-TO-INJECT PREFILLED
SYRINGE1
Discover more about the delivery
system, dosing, and administration

WHY SOMATULINE 
DEPOT IS A CHOICE FOR TREATMENT INITIATION1-4

PROVEN FOR PFS IN GEP-NETS1,2
Studied in multiple tumor locations including the pancreas for PFS

PROVEN IN CARCINOID SYNDROME1,3
See the results for the reduced need for rescue medication

A READY-TO-INJECT PREFILLED SYRINGE
Discover more about the delivery system, dosing & administration

A PROLONGED-RELEASE FORMULATION1,4
Learn more about the pharmacokinetic profile and onset of action

IPSEN CARES
A central support system for eligible patients. Find out more

Learn about the
Somatuline Depot Safety Profile

GEP-NET=gastroenteropancreatic neuroendocrine tumor; PFS=progression-free survival; SSA=somatostatin analog.

REFERENCES:

  • Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; July 2024.
  • Caplin ME, Pavel M, Ćwikła JB, et al.; on behalf of the CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224-233.
  • Vinik AI, Wolin EM, Liyanage N, et al.; on behalf of the ELECT Study Group. Evaluation of lanreotide depot/autogel efficacy and safety as a carcinoid syndrome treatment (ELECT): a randomized, double-blind, placebo-controlled trial. Endocr Pract. 2016;22(9):1068-1080.
  • Wolin EM, Manon A, Chassaing C, et al. Lanreotide depot: an antineoplastic treatment of carcinoid or neuroendocrine tumors. J Gastrointest Cancer. 2016;47(4):366-374.

IMPORTANT SAFETY 
INFORMATION & INDICATIONS

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 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.
  • 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

  • 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.

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 treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and
  • the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Please click here for the full Prescribing Information and Patient Information.

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Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S.
IPSEN CARES is a registered trademark of Ipsen S.A.
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All rights reserved. August 2024. SMD-US-003607 v4.0.