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
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%).
Deep Subcutaneous Injection and Formulation1,4-6
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?
- Ready-to-use: No reconstitution required
- Low injection volume
- Deep subcutaneous injection
Improvements to the Somatuline Depot syringe
- MOLDED TRAY protects syringe before use
- PLUNGER HEAD textured design for stability
- REINFORCED PLUNGER to help improve the injection process
- FINGER FLANGES are wide, curved, and textured to stabilize grip
- SYRINGE BODY is transparent and textured for improved grip
- NEEDLE CAP is large and easy to grip
Somatuline Depot continues to offer:
- Low injection volume (0.5 mL)
- Transparent body for visual confirmation of delivery
- Needle safety system to help minimize risk of needle-stick injuries
*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.
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 doses¹,⁴
- 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
IMPORTANT SAFETY INFORMATION & INDICATIONS
- 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%).
- 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).
- 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.
- 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.
- Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019.
- Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2018. This study has been funded by Ipsen.
- Caplin ME, Pavel M, Ćwikła JB, et al, for the CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224-233.
- Vinik AI, Wolin EM, Liyanage N, Gomez-Panzani E, Fisher GA; on behalf of the ELECT Study Group. Evaluation of lanreotide depot/autogel efficacy and safety as a carcinoid syndrome treatment (ELECT): a randomized, double-blind, placebo-controlled trial. Endocr Pract.2016;22(9):1068-1080.
- Ipsen data on file. IQVIA patient claims, 2015 Q1–2019 Q3.
- Adelman D, Truong Thanh X-M, Feuilly M, Houchard A, Cella D. 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. https://doi.org/10.1007/s12325-020-01255-8.
- Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2007.
- Ryan P, McBride A, Ray D, et al. Lanreotide vs octreotide LAR for patients with advanced gastroenteropancreatic neuroendocrine tumors: An observational time and motion analysis. J Oncol Pharm Pract. 2019;25(6):1425-1433.
- Adelman DT, Truong Thanh X-M, Mégret C. Enhancing patient care: co-creation and validation of a new and improved delivery system for lanreotide autogel/depot and its evaluation by US healthcare professionals. Presented at the 101st Annual Meeting and Expo of the Endocrine Society. New Orleans, LA; March 23-26, 2019.
- Giving a Subcutaneous Injection. Bethesda, MD: National Institutes of Health Clinical Center; July 2016.
- Wolin EM, Manon A, Chassaing C, et al. Lanreotide depot: an antineoplastic treatment of carcinoid or neuroendocrine tumors. J Gastrointest Cancer. 2016;47(4):366-374.