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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 (%)
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.
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
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%).
SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
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.
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. 4. Somatuline Depot (lanreotide) Injection [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; April 2019.