No reconstitution required

Somatuline® Depot (lanreotide) Injection 120 mg is supplied as a single, sterile, prefilled, ready-to-use, polypropylene syringe fitted with a 19-gauge, 20-mm needle covered by a low-density polythylene sheath.1

Somatuline Depot should be administered by a healthcare professional1

  • The recommended dose of Somatuline Depot is 120 mg administered every 4 weeks via the deep subcutaneous route in the superior external quadrant of the buttock
  • The injection site should alternate between the right and left sides from one injection to the next
  • The skin should be stretched and the needle should be inserted perpendicular to the skin, rapidly and to its full length

Somatuline Depot is indicated for deep subcutaneous injection2

  • If a patient is accidentally administered Somatuline Depot intramuscularly, then do not repeat the dose until the next regularly scheduled dosing interval
    • Pharmacokinetic studies in healthy volunteers have shown that Somatuline Depot, when administered subcutaneously or intramuscularly, has similar pharmacokinetic profiles

Prefilled Safe'n'Sound® syringe technology streamlines the administration process

  • Enhanced syringe design supports full-dose delivery
  • Utilizes a low-volume (0.5 mL) injection that is delivered through the deep subcutaneous route1
Indication

Somatuline® Depot (lanreotide) Injection 120 mg is 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.

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.

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. 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.
  • Cardiac Abnormalities: Somatuline Depot may decrease heart rate. In 81 patients with baseline heart rates of ≥60 beats per minute (bpm) treated with Somatuline Depot in the GEP-NETs clinical trial, the incidence of heart rate <60 bpm was 23% (19/81) with Somatuline Depot vs 16% (15/94) with placebo; 10 patients (12%) had documented heart rates <60 bpm on more than one visit. The incidence of documented episodes of heart rate <50 bpm or bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop 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.
  • Drug Interactions: The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels.
Adverse Reactions:

In the GEP-NET pivotal trial, the most common adverse reactions (incidence of >10% and more common than placebo) in patients treated with Somatuline Depot vs placebo were abdominal pain (34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction (15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%).

You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or to Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.

Please click here for full Prescribing Information and for full Important Safety Information.

References: 1. Somatuline Depot (lanreotide) Injection [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; December 2014. 2. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; 2007.