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Aero
 
Full Prescribing Information for Somatuline® Depot (lanreotide) Injection
Scroll down for complete Important Safety Information
 
logo Reduces the Frequency
of Short-acting Somatostatin Analog
Rescue Therapy
 
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On September 15, 2017, the U.S. Food and Drug Administration (FDA) approved a new indication for Somatuline® Depot (lanreotide) Injection for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
     
SOMATULINE DEPOT is also approved for the improvement of progression-free survival (PFS) in adults with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).1
     
 
IMPORTANT SAFETY INFORMATION
 
Contraindications
 
SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
 
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The additional SOMATULINE DEPOT approval for carcinoid syndrome was based on “Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled Trial,” published in Endocrine Practice.1,2
     
The new approval confirms Ipsen’s commitment to developing research-driven treatments to help patients battling cancer.
     
SOMATULINE DEPOT is associated with a number of Warnings and Precautions including: cholelithiasis and gallbladder sludge, hypoglycemia or hyperglycemia, and cardiovascular abnormalities.
Please see below for additional Important Safety Information.
     
The recommended dose of SOMATULINE DEPOT for the treatment of carcinoid syndrome remains at 120 mg administered once every 4 weeks by deep subcutaneous injection in the superior external quadrant of the buttock, the same recommended dosing for GEP-NETs. If patients are already being treated with SOMATULINE DEPOT for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome.
     
The FDA has assigned national drug code (NDC) 15054-1120-03 to SOMATULINE DEPOT for a dosage strength of 120 mg. This NDC code is appropriate for use with the additional indication.
     
For claims processing purposes, please note with the expanded label, the appropriate ICD-10 diagnosis code includes the following*: E34.0 (Carcinoid Syndrome).
     
Diagnosis codes previously used in association with SOMATULINE DEPOT treatment for GEP-NETs will remain the same, which include*:
 
• C7A.xx (Malignant carcinoid tumor of xx)
 
• C7B.xx (Secondary carcinoid tumors of xx)
 
• C24.1 (Malignant neoplasm of the Vater)
 
• C25.4 (Malignant neoplasm of the endocrine pancreas)
SOMATULINE DEPOT is intended to be administered by a healthcare provider. The HCPCS code for SOMATULINE DEPOT is J1930 per 1 mg. To report the use of an entire 120 mg pre-filled syringe of SOMATULINE DEPOT you must report 120 units.
     
* All billing and coding decisions are the responsibility of the HCP. Ipsen does not guarantee any specific reimbursement results.
     
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IMPORTANT SAFETY INFORMATION (continued)
 
Warnings and Precautions
 
Cholelithiasis and Gallbladder Sludge
     
SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation
     
Periodic monitoring may be needed.
 
Hypoglycemia or Hyperglycemia
     
Pharmacological studies show that SOMATULINE DEPOT, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. 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 in the GEP-NET pivotal trial, 23% of SOMATULINE DEPOT-treated patients had a heart rate of less than 60 bpm compared to 16% of placebo-treated patients. The incidence of bradycardia was similar in the treatment groups. Initiate appropriate medical management in patients with symptomatic bradycardia.
     
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 occurring in greater than 10% of patients who received SOMATULINE DEPOT in the GEP- NET trial 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 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%).
 
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/medwatch.
 
Please see Full Prescribing Information and Patient Information for SOMATULINE DEPOT.
 
References: 1. Somatuline® Depot (lanreotide) Injection Prescribing Information. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc. 2. Vinik AI, Wolin EM, Liyanage N, et al. Endo Pract. 2016;22:1068-1080.
 
     
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© 2017 Ipsen Biopharmaceuticals, Inc.
All rights reserved. November 2017 SMD-US-001844
Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S
     

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