PROVEN TO SLOW THE GROWTH OF GEP‑NETs IN PATIENTS WHOSE DISEASE HAS SPREAD OR CANNOT BE REMOVED BY SURGERY

Somatuline® Depot: chosen by over 4,700 doctors since 2017*

*Prescription data based on IQVIA insurance claims for NETs during November 2017–October 2019 Q3, subject to change without notice.

 

53% reduction in risk of progression or death

In clinical studies, Somatuline Depot reduced the risk of disease progression or death by 53% versus placebo. At 22 months, more than half of the patients taking Somatuline Depot did not have their cancer progress. For those taking placebo, it took 16.6 months until half the patients had their cancer progress.

About the study

Somatuline Depot was studied for nearly 2 years in 204 adult patients with various types of GEP-NETs that had spread or could not be removed by surgery. In some patients, the cancer started in their pancreas. In others, it started in a different place, such as their intestinal tract, which includes the colon.

 

Patients in the study were divided into 2 groups, which received either Somatuline Depot 120 mg or placebo by deep subcutaneous injection every 4 weeks. The primary goal of this study was to determine if Somatuline Depot improved progression-free survival, which is the amount of time it took for the disease to progress.

15% absolute reduction in number of rescue medication days

FDA-approved to treat adults with carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine

Short-acting medicines are used to lessen symptoms of carcinoid syndrome, including diarrhea and flushing. Somatuline Depot was shown to reduce the use of short-acting medicines by 15%.

About the study

Somatuline Depot was studied for 16 weeks in 115 patients with confirmed NETs and a history of carcinoid syndrome (flushing and/or diarrhea) to reduce the need for use of short-acting somatostatin medicine.

 

Patients were divided into 2 groups, which received either Somatuline Depot 120 mg or placebo by deep subcutaneous injection every 4 weeks. Many patients were living with carcinoid syndrome as a result of being diagnosed with NETs for less than a year before starting treatment.

Common side effects

For people with carcinoid syndrome, the most common side effects were: headache, dizziness, and muscle spasm. Side effects for carcinoid syndrome were generally similar to those commonly seen in the GEP-NETs trial.

 

It’s important to know what side effects are commonly associated with Somatuline Depot, so you can discuss them with your medical team.


IMPORTANT SAFETY INFORMATION & INDICATIONS

  • Do not take SOMATULINE DEPOT if you are allergic to lanreotide.
  • SOMATULINE DEPOT may cause serious side effects, including:
    • Gallstones 
    • Changes to your blood sugar (high or low blood sugar), 
    • Slow heart rateand 
    • High blood pressure.
  • Tell your healthcare provider (HCP) if you have any of the following symptoms: 
    • Symptoms of gallstones may include sudden pain in your upper right stomach area (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, and nausea.
    • Symptoms of high blood sugar may include increased thirst, increased appetite, nausea, weakness or tiredness, urinating more than normal, and fruity smelling breath.
    • Symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, irritability or mood changes, and hunger.
    • Symptoms of slow heart rate may include dizziness or lightheadedness, fainting or near-fainting, chest pain, shortness of breath, confusion or memory problems, and weakness or extreme tiredness.
  • The most common side effects of SOMATULINE DEPOT in people with: 
    • GEP-NETs: stomach area (abdominal) pain; muscle and joint aches; vomiting; headache; pain, itching or a lump at the injection site
    • Carcinoid syndrome: headache, dizziness, muscle spasm; side effects were generally similar to those commonly seen with GEP‑NETs
  • SOMATULINE DEPOT may cause dizziness. If this happens, do not drive a car or operate machinery.
  • Tell your HCP right away if you have signs of an allergic reaction after receiving SOMATULINE DEPOT, including swelling of your face, lips or tongue; breathing problems; fainting, dizziness or feeling lightheaded (low blood pressure); itching; skin flushing or redness; rash; or hives.
  • Before taking SOMATULINE DEPOT, tell your HCP about all your medical conditions including if you: have diabetes; have gallbladder, heart, thyroid, kidney or liver problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if SOMATULINE DEPOT will harm your unborn baby or pass into breast milk. You should not breastfeed if you receive SOMATULINE DEPOT and for 6 months after your last dose. SOMATULINE DEPOT may affect your ability to become pregnant.
  • Tell your HCP about all the medicines you take,  including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOMATULINE DEPOT and other medicines may affect each other, causing side effects. SOMATULINE DEPOT may affect the way other medicines work, and other medicines may affect how SOMATULINE DEPOT works. Your dose of SOMATULINE DEPOT or your other medications may need to be changed. If you have diabetes, your HCP may change your dose of diabetes medication when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT is changed.
  • Especially tell your HCP if you take:
    • Insulin or other diabetes medicines,
    • A cyclosporine (Gengraf, Neoral, or Sandimmune), or
    • Medicines that lower your heart rate, such as beta blockers.

Know the medicines you take. Keep a list of them to show your HCP when you get a new medicine.

Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SOMATULINE DEPOT. For more information, ask your HCP.

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/medwatch.

What is SOMATULINE® DEPOT (lanreotide) Injection? 

SOMATULINE DEPOT is a prescription medicine used in adults for:

  • the treatment of a type of cancer known as neuroendocrine tumors, from the gastrointestinal tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery; and
  • the treatment of carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine.

It is not known if SOMATULINE DEPOT is safe and effective in children.

 

Please see full Prescribing Information, including Patient Information.

©2020 Ipsen Biopharmaceuticals, Inc. All rights reserved. September 2020. SMD-US-004048