ADMINISTRATION
Administration

HOW TO ADMINISTER SOMATULINE DEPOT (LANREOTIDE)

How to use the syringe

Somatuline Depot (lanreotide) is intended to be administered by a healthcare provider through deep subcutaneous injection only. Learn how to use Somatuline Depot syringe by downloading the administration guide below.

DO remove from refrigerator and let sealed pouch sit for 30 minutes to reach room temperature*

DON’T open sealed pouch or inject medication that has not yet reached room temperature; injecting cold medication may be painful for your patient

An illustration showing a needle going through layers of the skin to the deep subcutaneous tissue

DO administer deep subcutaneous injection only

DON’T administer medication intramuscularly. If you do, do not administer another dose

Illustration highlighting the upper outer quadrant of the right and left buttock

DO administer in the upper outer quadrant of the right or left buttock

DON’T administer in the arm, calf, abdomen, or any other part of the body

Illustration showing the left and right buttock, highlighting the need to alternate injection sites

DO alternate injection sites between appointments

DON’T inject in the same location as the last appointment

Illustration showing a hand stretching the skin on the upper left buttock

DO flatten the area by using your thumb and index finger to spread the skin

DON’T fold, squeeze, or pinch the skin

Illustration of a needle being injected at a 90-degree angle

DO insert needle at a 90 degree angle only, and all the way into the skin (the needle should not be visible)

DON’T aspirate (draw back the plunger) before injecting, or inject at an angle other than 90 degrees

*Product left in its sealed pouch at room temperature (not to exceed 104°F or 40°C) for up to 24 hours may be returned to the refrigerator for continued storage and use at a later time.¹

REFERENCE:

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

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.