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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%).
Redesigned Delivery System*
You demanded more and we acted. From a prefilled syringe to a more ergonomic design, the redesigned Somatuline Depot syringe retains all the features you prefer, and introduces new ones designed to help streamline administration and place added stability and control in your hands.
What helps make Somatuline Depot simple to administer?
Improvements to the Somatuline Depot syringe
Somatuline Depot continues to offer:
*The Somatuline Depot delivery system was updated to provide an improved ergonomic injection experience, based on user feedback. Through a series of 4 formative studies between 2015 and 2017, Ipsen sought feedback from acromegaly and NET patients, nurses and caregivers on the design and functionality of new delivery device prototypes.
These culminated in a human factors validation study in 2017 in which the final delivery system prototype was tested to determine whether the product could be safely and effectively used by intended users in the intended use environment. Key changes between the currently marketed injection system and the new injection system are: an overcap to improve the ergonomics (and needle shield removal); plunger support for the new injection system; and improved version of the needle safety system.
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.