Studied in Patients With Different Types of GEP-NETs
SOMATULINE DEPOT was studied for nearly 2 years in people with various types of gastrointestinal and pancreatic
neuroendocrine tumors (GEP-NETs) that had spread or could not be removed by surgery. In some people, the cancer
started in their pancreas. In others, it started in a different place, such as their colon or intestines.
People who participated in the study were divided into 2 patient groups and given either SOMATULINE DEPOT or placebo.
The 2 patient groups in the study were similar:
- Both groups included patients who had a variety of tumor types and treatment histories
- The average age of the patients was 63 years
Before they entered this study, some people had received other treatments for GEP-NETs, including surgery,
chemotherapy, or other drug therapy, but not within 6 months of the start of the study
- Most people in the study (84%) had not received any form of medical therapy for their GEP-NETs before the study
At study entry there was one difference between the 2 groups:
More patients in the SOMATULINE DEPOT group compared with placebo (39% vs 27%) had cancer in a large
portion (more than 25%) of their liver
Slow the Growth or Spread of GEP-NETs
The majority of patients on SOMATULINE DEPOT did not yet experience disease progression during the 22-month
study, while half of patients on placebo had disease progression by 16.6 months.
What is SOMATULINE® DEPOT (lanreotide) Injection 120 mg?
SOMATULINE DEPOT is a prescription medicine used for the treatment of adult
patients with 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.
It is not known if SOMATULINE DEPOT is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Who should not take SOMATULINE DEPOT?
Do not take SOMATULINE DEPOT if you are allergic to lanreotide.
What are the possible side effects of SOMATULINE DEPOT?
SOMATULINE DEPOT may cause serious side effects, including:
Gallstones. Tell your healthcare professional if you get any of these symptoms:
- 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
Changes in your blood sugar (high blood sugar or low blood sugar). If you have
diabetes, test your blood sugar as your healthcare professional tells you to. Your healthcare
professional may change your dose of diabetes medicine.
- Slow heart rate
- High blood pressure
The most common side effects of SOMATULINE DEPOT in people with GEP-NETs include stomach area (abdominal)
pain, muscle and joint aches, vomiting, headache, and pain, itching, or a lump at the injection site.
The most common side effects of SOMATULINE DEPOT in people with GEP-NETs include stomach area (abdominal) pain, muscle and joint aches, vomiting, headache, and pain, itching, or a lump at the injection site.
SOMATULINE DEPOT may cause dizziness. If this happens, do not drive a car or operate machinery.
What should I tell my healthcare professional before receiving SOMATULINE DEPOT?
Tell your healthcare professional if you have diabetes or gallbladder, thyroid, heart, kidney, or
Tell your healthcare professional if you are pregnant or plan to become pregnant as SOMATULINE DEPOT
may harm your unborn baby. Tell your healthcare professional if you are breastfeeding or plan to
breastfeed. It is not known if SOMATULINE DEPOT passes into your breast milk. You and your healthcare
professional should decide if you will take SOMATULINE DEPOT or breastfeed. You should not do both.
Tell your healthcare professional 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.
Especially tell your healthcare professional if you take insulin or other diabetes medicines,
a cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset),
or medicines that lower your heart rate, such as beta blockers.
Tell your healthcare professional 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 healthcare
You may report side effects to FDA at 1‑800‑FDA‑1088 or Ipsen Biopharmaceuticals, Inc. at 1‑888‑980‑2889.
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