Safety profile consistent with 8 years of Somatuline® Depot Injection experience in the U.S.1

Adverse Reactions Occurring in >5% of Somatuline Depot-Treated Patients and Occurring More Commonly Than in Placebo-Treated Patients (>5% higher incidence) in the Phase III Trial1
Somatuline Depot 120 mg
(n=101) (%)
Placebo
(n=103) (%)
Any (%) Severe** (%) Any (%) Severe** (%)
Any Adverse Reaction 88 26 90 31
Abdominal paina 34* 6* 24* 4
Musculoskeletal painb 19* 2* 13 2
Vomiting 19* 2* 9* 2*
Headache 16 0 11 1
Injection site reactionc 15 0 7 0
Hyperglycemiad 14* 0 5 0
Hypertensione 14* 1* 5 0
Cholelithiasis 14* 1* 7 0
Dizziness 9 0 2* 0
Depressionf 7 0 1 0
Dyspnea 6 0 1 0
  • aIncludes preferred terms of abdominal pain, abdominal pain upper/lower, abdominal discomfort
  • bIncludes preferred terms of myalgia, musculoskeletal discomfort, musculoskeletal pain, back pain
  • cIncludes preferred terms of infusion site extravasation, injection site discomfort, injection site granuloma, injection site hematoma, injection site hemorrhage, injection site induration, injection site mass, injection site nodule, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling.
  • dIncludes preferred terms of diabetes mellitus, glucose tolerance impaired, hyperglycemia, type 2 diabetes mellitus
  • eIncludes preferred terms of hypertension, hypertensive crisis
  • fIncludes preferred terms of depression, depressed mood
  • *Includes one or more serious adverse events (SAEs) defined as any event that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability, results in congenital anomaly/birth defect, or may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed.
  • **Defined as hazardous to well-being, significant impairment of function or incapacitation.

Low discontinuation rates due to treatment-emergent adverse reactions1

  • 5% (5/101) in the Somatuline Depot arm and 3% (3/103) in the placebo arm
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.

Reference: 1. Somatuline Depot (lanreotide) Injection [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; December 2014.