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  • ADMINISTRATION
  • Delivery System

PREFILLED…1,2

Somatuline® Depot syringe is designed to streamline in-office preparation and administration2

Somatuline Depot also offers:

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PREFILLED

Somatuline Depot is provided in a prefilled, ready-to-inject syringe intended to be administered by a healthcare provider. No reconstitution or assembly required.

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LOW VOLUME

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

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Somatuline Depot also offers:

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TRANSPARENT BODY

For visual inspection of particulate matter and discoloration.3

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NEEDLE SAFETY SYSTEM

To help minimize the risk of needle-stick injuries.1,2

… AND PREFERRED1

The Somatuline Depot syringe was preferred over octreotide LAR syringe by 97.8% of nurses in a simulated-use study*1

Here’s what nurses preferred about the Somatuline Depot syringe

Top performance attributes:1
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Fast administration time from preparation to injection

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Easy to use during preparation

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

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Somatuline Depot syringe was designed with patients, caregivers, and healthcare providers taking part in the process.3

Somatuline Depot has been shown to reach peak serum concentration in 7 hours followed by a steady and sustained release2

 

Only Somatuline® Depot offers a prefilled dose with a sturdy plunger and needle safety system redesigned in 2019 to improve the monthly injection process.1-3

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.

PRESTO Study Design1

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.

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

REFERENCES:

  • 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.
  • Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; February 2023.
  • Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2018. This study has been funded by Ipsen.

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.

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.