3 Reasons.
1 Somatuline® Depot

Progression-Free Survival (PFS) in Patients With GEP-NETs*

For unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs

The efficacy of Somatuline Depot was tested in a phase III, 96-week, international, randomized, double-blind, placebo-controlled trial called CLARINET.1,2†

At the end of 22 months, the median PFS was not yet reached for Somatuline Depot compared to 16.6 months for placebo (95% CI: 11.2-22.1)¹

Number of events (%)

  • Somatuline Depot=32 (31.7)
  • Placebo=60 (58.3)

The efficacy of Somatuline Depot was studied in 204 patients with unresectable, well- or moderately-differentiated, metastatic or locally advanced, gastroenteropancreatic neuroendocrine tumors. Patients were required to have nonfunctioning tumors without hormone-related symptoms.¹

For additional information about the study methodology, please see Study Design and Patient Information below.

Adverse Reactions Reported in CLARINET Study

Most common adverse reactions (greater than 10%) are abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.¹ Please see Adverse Reactions below for more information about these possible side effects. Please tap or click here to review the full Important Safety Information for Somatuline Depot.

*GEP-NETs=gastroenteropancreatic neuroendocrine tumors.
†CLARINET=Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors. 

PFS in GEP-NETs

Carcinoid Syndrome1

Somatuline Depot is FDA-approved to treat adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

The most common adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions occurring in greater than 5% of patients who received Somatuline Depot in the carcinoid syndrome trial and occurring at least 5% greater than placebo were headache (12%), dizziness (7%), and muscle spasm (5%).

Carcinoid Syndrome

Deep Subcutaneous Injection and Formulation1,3

  • Provided in a prefilled, low-volume, single-use syringe intended for administration by a healthcare provider
  • Recommended dose is 120 mg/0.5 mL administered every 4 weeks via deep subcutaneous injection to the superior external quadrant of the buttock
    • Remove from refrigerator 30 minutes prior to administration and allow to come to room temperature with pouch sealed until just prior to injection
    • Injection site should alternate between right and left sides
    • Skin should not be folded and needle should be inserted perpendicular to the skin, rapidly and to its full length
  • If already being treated for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome

 

Liquid Crystal Formulation

  • A high density of nanotubes allows for a low injection volume in the ready-to-use prefilled syringe. It is believed that lanreotide forms a depot that functions as a reservoir for the drug between extended doses¹,
  • Lanreotide is slowly released, enabling once-monthly delivery via deep subcutaneous injection. Lanreotide passively diffuses toward the surrounding tissues and is absorbed into the bloodstream¹

Delivery

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-NETsAdverse 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 SyndromeAdverse 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

  • LactationAdvise 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/medwatch.

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.

References: 1. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2007. 2. Wolin EM, Manon A, Chassaing C, et al. Lanreotide depot: an antineoplastic treatment of carcinoid or neuroendocrine tumors. J Gastrointest Canc. 2016;47(4):366-374. 3. Pandit A, Fay N, Bordes L, et al. Self-assembly of the octapeptide lanreotide and lanreotide-based derivatives: the role of the aromatic residues. J Pept Sci. 2008;14(1):66-75. 4Somatuline Depot (lanreotide) Injection [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; April 2019.

©2019 Ipsen Biopharmaceuticals, Inc. All rights reserved. March 2019 SMD-US-002660

Are you a healthcare provider?

This site is intended for U.S. healthcare providers only.

By clicking YES, you attest you are a healthcare provider licensed in the U.S.

YES   NO