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Top performance attributes6:
Fast administration time from preparation to injection
Easy to use during preparation
What makes the SOMATULINE DEPOT syringe different?1,8
PREFILLED SYRINGE: No reconstitution required. The syringe is ready to inject, which can help reduce preparation time.
LOW-VOLUME: The injection volume of Somatuline Depot is 0.5 mL.
See what nurses preferred about the Somatuline Depot syringe6:
*From preparation to injection.
PRESTO: Long-acting SSA syringe preference study6
A randomized, multinational, multicenter, noninterventional, simulated-use study:
- Objective: The primary objective of this study was to assess the preferences of nurses between the SOMATULINE DEPOT syringe and the SANDOSTATIN LAR DEPOT syringe
- Participants: Nurses (N=90) with experience administering SOMATULINE DEPOT and SANDOSTATIN LAR
- 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 which resulted in 2 separate cohorts, and that 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. No assessment of efficacy or safety should be made based on this study
PRESTO=The PREference STudy of lanreOtide autogel.
Redesigned to improve administration2
When it comes to Somatuline Depot, delivery matters. That’s why the Somatuline Depot syringe was redesigned with patients, caregivers, and healthcare providers taking part in the process (see the “Updated Somatuline Depot Syringe Study Design” information below). Offering a prefilled dose, sturdy plunger, and needle safety system, the redesigned syringe can help improve the monthly injection process.
Somatuline Depot continues to offer1,2,8,9:
PREFILLED SYRINGE with no reconstitution required. The syringe is ready to inject, which can help reduce preparation time.
TRANSPARENT BODY for visual confirmation of delivery.
NEEDLE SAFETY SYSTEM to help minimize the risk of needle-stick injuries.
LOW-VOLUME injection of 0.5 mL.
Updated Somatuline Depot syringe study design2
The Somatuline Depot delivery system was updated in response to feedback, provided by nurses, and caregivers, during 4 formative studies regarding the design and functionality of updated delivery device prototypes. The subsequent human factors validation study in 2017 reviewed the use of the updated delivery system by intended users in the intended use environment. Most common errors among HCPs (N=35) were failure to follow correct procedure if the syringe was dropped (34%) and failure to inspect the product before administration (34%); no task errors were specific to the delivery system. Key changes between the previously marketed delivery system and the updated delivery system are: an overcap to improve the ergonomics (and needle shield removal); plunger support for the updated delivery system; and an improved version of the needle safety system.
Watch a video about how to use the redesigned syringe.
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.
Please click here for the full Prescribing Information and Patient Information.
References:
- 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.