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  • ADMINISTRATION
  • Delivery System & Dosing

A PROLONGED-RELEASE FORMULATION FOR 
DEEP SUBCUTANEOUS INJECTION1

Illustration of a syringe

SOMATULINE DEPOT IS A DEEP SUBCUTANEOUS INJECTION1

Illustration of an HCP

DELIVERY SYSTEM

Somatuline Depot is available as sterile, ready-to-use, single-dose prefilled syringes and is intended to be administered by a healthcare provider.1

Illustration of a droplet, representing the injection volume

INJECTION VOLUME

The injection volume of Somatuline Depot is 0.5 mL for GEP-NETs and carcinoid syndrome.1

Illustration of a buttock, highlighting the administration area

DOSAGE

Recommended dose is 120 mg/0.5 mL administered every 4 weeks for GEP-NETs and carcinoid syndrome.1

THE SOMATULINE DEPOT SYRINGE WAS PREFERRED OVER THE OCTREOTIDE LAR DEPOT SYRINGE BY 97.8% OF NURSES IN A SIMULATED-USE STUDY*2

PRESTO Study Design2

PRESTO = The PREference STudy of lanreOtide autogel.

Study: A randomized, multinational, multicenter, noninterventional, simulated-use study.

Objective: The primary objective of this Ipsen-sponsored study was to assess the preferences of nurses between the Somatuline® Depot syringe and the octreotide LAR depot syringe.

Participants: Nurses (N=90) with experience administering Somatuline Depot and octreotide LAR depot.

Method: Nurses attended a single testing session, during which they injected injection pads with each type of syringe twice before reporting their preferences. Data were collected using an anonymous, self-administered, web-based questionnaire.

Limitations: Limitations of this study included the need for a change in injection pad after 10 injection sessions due to clogging issues that resulted in 2 separate cohorts, and the injections performed were simulated. There were imbalances noted in the sociodemographics and the clinical settings of nurses that potentially introduced bias in the reporting of preferences. Another limitation was that some nurse respondents were from the Contract Research Organizations (CRO) network. This study was not designed to evaluate the efficacy or safety of Somatuline Depot or octreotide LAR, and no assessment of efficacy or safety should be made based on this study.

*Injection administration comparison is not intended to imply benefit of clinical efficacy or safety.

See what nurses preferred 
about the Somatuline Depot 
syringe vs the octreotide LAR 
syringe1

From a scale of 1 (not at all) to 5 (very much):

Nurse Preference

Somatuline Depot

Sandostatin LAR Depot

Ease of use during preparation

4.8

2.7

Ease of use during injection

4.6

2.9

Fast to administer from preparation to injection

4.8

2.1

Comfortable to hold during use†

4.5

3.4

Sturdy plunger

4.4

3.4

Convenience of syringe format and packaging†

4.6

2.8

†Study conducted with originally approved version of the syringe.

Learn about Somatuline
Depot Administration

GEP-NET=gastroenteropancreatic neuroendocrine tumor; LAR=long-acting repeatable.

REFERENCES:

  • Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; July 2024.
  • Adelman D, Truong Thanh X-M, et al. Evaluation of nurse preferences between the lanreotide autogel new syringe and the octreotide long-acting release syringe: an international simulated-use study (PRESTO). Adv Ther. 
    2020;37(4):1608-1619.

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.
All other trademarks and registered trademarks are the property of their respective owners.

© 2024 Ipsen Biopharmaceuticals Inc.
All rights reserved. August 2024. SMD-US-003607 v4.0.