ADMINISTRATION
Formulation

SOMATULINE^® DEPOT IS A DEEP SUBCUTANEOUS INJECTION WITH ONCE-MONTHLY DOSING VIA A STERILE, READY-TO-USE, SINGLE-DOSE, PRE-FILLED SYRINGE^1,2

SOMATULINE^® DEPOT
IS A DEEP
SUBCUTANEOUS
INJECTION WITH
ONCE-MONTHLY
DOSING VIA A STERILE,
READY-TO-USE, SINGLE-
DOSE, PRE-FILLED
SYRINGE^1,2

Illustration showing a pre-filled syringe

The formulation of Somatuline Depot enables steady release without the need for polymers or additives.²

Illustration showing lanreotide nanotubes

High density of lanreotide nanotubes allows for low injection volume.²

Illustration showing lanreotide being injected into the deep subcutaneous layer of tissue

Lanreotide is injected into the deep subcutaneous layer of the tissue. After injection, the formulation is thought to form a depot – or drug reservoir, for fast-acting (peak serum concentration of 7 hours) and sustained-release (half-life of 23 to 30 days) drug delivery.^1,2

Illustration showing lanreotide being slowly released

Lanreotide is slowly released, enabling delivery every 4 weeks.²

Somatuline Depot, a rapid onset of action and sustained-release formulation^1,2

Somatuline Depot has been shown to reach peak serum concentration in 7 hours, followed by a steady and sustained release (half-life of 23 to 30 days)^1,2

Serum concentrations achieved in healthy subjects following deep SC administration of Somatuline Depot²

Study design and patient population information

SC=subcutaneous.

REFERENCES:

Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; July 2024.
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.

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.

Steatorrhea and Malabsorption of Dietary Fats

New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including SOMATULINE DEPOT. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss.
If new occurrence or worsening of these symptoms are reported in patients receiving SOMATULINE DEPOT, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

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.

SOMATULINE® DEPOT IS A DEEP SUBCUTANEOUS INJECTION WITH ONCE-MONTHLY DOSING VIA A STERILE, READY-TO-USE, SINGLE-DOSE, PRE-FILLED SYRINGE1,2

SOMATULINE® DEPOTIS A DEEPSUBCUTANEOUSINJECTION WITHONCE-MONTHLYDOSING VIA A STERILE,READY-TO-USE, SINGLE-DOSE, PRE-FILLEDSYRINGE1,2

Somatuline Depot, a rapid onset of action and sustained-release formulation1,2

Somatuline Depot has been shown to reach peak serum concentration in 7 hours, followed by a steady and sustained release (half-life of 23 to 30 days)1,2

Serum concentrations achieved in healthy subjects following deep SC administration of Somatuline Depot2

IMPORTANT SAFETY INFORMATION & INDICATIONS