Healthcare professional resources

Below are resources created to help you learn about Somatuline® Depot (lanreotide) Injection 120 mg for the treatment of your patients with gastrointestinal and pancreatic neuroendocrine tumors (NETs).

Case Studies:
Who are your Somatuline Depot patients?*

Newly Diagnosed Pancreatic NET

Patient History
  • 56-year-old female
  • Experiencing right upper-quadrant abdominal pain for >2 months
Pathology
  • Well-differentiated pancreatic NET with Ki67 index 7% (Grade 2)
  • Radiographic imaging indicated
    • Single pancreatic mass
    • Hepatic metastases with a tumor load >25%
  • Octreoscan revealed high levels of uptake in
    • Primary tumor
    • Liver metastases
Conclusion
  • Primary tumor and metastases were determined to be inoperable
What treatment would you recommend for this patient?

Newly Diagnosed Gastrointestinal NET

Patient History
  • 68-year-old male
  • Complaining of hyperemesis, nausea, and severe pain in lower right abdomen
  • Patient also reported facial flushing, mild and intermittent abdominal pain, and weight loss for 2 months
Pathology
  • Well-differentiated terminal ileal (GI) NET with Ki67 index 8% (Grade 2)
  • Abdominal CT scan revealed
    • Terminal ileal mass
    • Several hepatic masses
Conclusion
  • Disease and hepatic masses were deemed inoperable
What treatment would you recommend for this patient?

Newly Diagnosed Pancreatic NET

Patient History
  • 59-year-old female with chest pain secondary to a broken rib
Pathology
  • CT scan confirmed broken rib but also identified several small pancreatic and hepatic masses
  • Tumor was a well-differentiated pancreatic NET with Ki67 index 1% (Grade 1)
  • Hepatic metastases showed a tumor load <10%
  • Octreoscan revealed
    • Faint uptake in pancreas
    • Uptake in liver metastases >1 cm
Conclusion
  • Primary tumor and metastases were deemed to be inoperable
What treatment would you recommend for this patient?

*Based on actual patient cases; names and images are representative only.

A Clinician's Perspective

Dr. Alexandria Phan, Director of GI Medical Oncology at the Houston Methodist Hospital, reviews the important clinical benefits of Somatuline Depot. She highlights the efficacy results of the landmark clinical trial, CLARINET (Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors), and discusses the dosing and administration process. Click the image to watch the video.

Formulation Video1

The unique formulation of Somatuline Depot—from its liquid crystal technology to its sustained-release activity—permits once-monthly dosing. Click the image to watch the video.

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. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; 2007.