Important Safety Information   |   Prescribing Information   |   For Healthcare Professionals

What is Some Important Information About Somatuline® Depot I Should Know?

What are possible side effects of Somatuline Depot?

Somatuline Depot may cause serious side effects, including:

  • Gallstones. Tell your doctor if you have any of these symptoms including: sudden pain in your upper right stomach area (abdominal), right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, and/or nausea
  • Changes in your blood sugar. Your doctor may change your dose of diabetes medicine especially when you first start receiving Somatuline Depot or if your dose of Somatuline Depot changes.
  • Slow heart rate
  • High blood pressure

How Somatuline Depot is administered

  • You will receive a Somatuline Depot injection every 4 weeks as directed by your doctor. Your doctor may change your dose of Somatuline Depot or the length of time between injections. Your doctor will tell you how long you need to receive Somatuline Depot.
  • Somatuline Depot is injected deep under the skin of the upper outer area of your buttock.
  • Your injection site should change (alternate) between your right and left buttock each time you receive an injection of Somatuline Depot.
  • During your treatment with Somatuline Depot, your doctor may do certain blood tests to see if Somatuline Depot is working. Your doctor may change your dose or length of time between your Somatuline Depot injections as needed.

Possible side effects

Somatuline Depot may cause serious side effects, including:

  • gallstones. Tell your doctor if you have 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 doctor tells you to. Your doctor may change your dose of diabetes medicine especially when you first start receiving Somatuline Depot or if your dose of Somatuline Depot changes.
  • slow heart rate
  • high blood pressure

In pooled studies totaling more than 400 patients, the most common side effects of Somatuline Depot were:

  • diarrhea
  • stomach area (abdominal) pain
  • nausea
  • pain, itching, or lump at the injection site
  • flatulence
  • headache
  • vomiting
  • loose stools

Tell your doctor 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 doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Individual response to any acromegaly therapy will vary from patient to patient. Ask your endocrinologist if Somatuline® Depot therapy is right for you.

Important Information About Somatuline Depot

Your doctor is your primary source of information about treatment. For more information, please talk to your doctor and see the full Patient Information. Before each treatment, please read the Patient Information that comes with each package of Somatuline Depot (lanreotide) Injection, as there may be new information.

Who is Somatuline Depot for?

Somatuline Depot is a prescription medicine used for the long-term treatment of people with acromegaly when:

  • surgery or radiotherapy have not worked well enough or
  • they are not able to have surgery or radiotherapy

It is not known if Somatuline Depot is safe and effective in children.

Before taking Somatuline Depot, you should talk to your doctor about all of your medical conditions and medicines you are taking, including if you have:

  • Gallbladder, thyroid, heart, kidney, and liver problems
  • Diabetes
  • Are allergic to latex or natural dry rubber
  • Are taking cyclosporine (Gengraf, Neoral, Sandimmune)
  • Are receiving medicines that lower heart rate such as beta-blockers
  • Are taking a medicine called bromocriptine (Parlodel)
  • Are pregnant, plan to become pregnant, breast-feeding, or plan to breast-feed, it is not known if Somatuline Depot could harm your unborn baby or passes into your breast milk

What are possible side effects of Somatuline Depot?

Somatuline Depot may cause serious side effects, including:

  • Gallstones. Tell your doctor if you have any of these symptoms including: sudden pain in your upper right stomach area (abdominal), right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, and/or nausea
  • Changes in your blood sugar. Your doctor may change your dose of diabetes medicine especially when you first start receiving Somatuline Depot or if your dose of Somatuline Depot changes.
  • Slow heart rate
  • High blood pressure

The most common side effects of Somatuline Depot include: diarrhea, stomach area (abdominal) pain, nausea, and pain, itching, or lump at the injection site.

Tell your doctor 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 doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For more information, please talk to your doctor and see the full Patient Prescribing Information.