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.
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/medwatch.
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.
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]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019. 5. Adelman DT, Truong Thahn 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, 2018. 6. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2018. This study has been funded by Ipsen.
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