What is SOMATULINE^® DEPOT (lanreotide) Injection?

SOMATULINE DEPOT is a prescription medicine used for the treatment of adults for:

• The long-term treatment of acromegaly when surgery or radiotherapy has not worked well enough or the patient is not able to have surgery or radiotherapy
• 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
  • nausea
• 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 acromegaly include diarrhea, stomach area (abdominal) pain, nausea, 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 liver problems.
• 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. 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 professional.

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or Ipsen Biopharmaceuticals, Inc.
at 1-888-980-2889.