What Should I Expect With SOMATULINE® DEPOT (lanreotide) Injection 120 mg?

You May Have Questions About Your Treatment

If your doctor has determined that SOMATULINE DEPOT is right for you, you may have questions about what you can expect while on treatment. This section provides information about the possible side effects with SOMATULINE DEPOT, as well as information about how your doctor will administer it.

Be sure to talk with your healthcare team if you still have questions after reviewing the information found here.

SOMATULINE DEPOT Is the First Prescription Medicine...

Approved by the United States Food and Drug Administration (FDA) to treat GEP-NETs by slowing down disease progression in either gastrointestinal or pancreatic NETs that have spread or cannot be removed by surgery.

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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 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.

To learn more, please see additional Important Safety Information throughout this website or go to this icon located at the top of the page.

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How Will I Receive SOMATULINE® DEPOT(lanreotide) Injection 120 mg?

A Ready-for-Use Injection, Given by Your Healthcare Professional

You will be given an injection of SOMATULINE DEPOT in your doctor’s office every 4 weeks. SOMATULINE DEPOT comes as a ready-for-use syringe that does not require any mixing prior to the injection.

SOMATULINE DEPOT is injected deep under the skin of the upper outer area of your buttock. Your doctor or nurse will change or alternate your injection site between your right and left buttock from one visit to the next.

Your doctor will advise you on how long to continue treatment with SOMATULINE DEPOT. Talk with your doctor if you have any questions about your treatment with SOMATULINE DEPOT.

Do not take SOMATULINE DEPOT if you are allergic to lanreotide.

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.

SELECT IMPORTANT SAFETY INFORMATION

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 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.

To learn more, please see additional Important Safety Information throughout this website or go to this icon located at the top of the page.

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What Are The Possible Side Effects?

Patients May Experience Side Effects

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 especially when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT changes
  • Slow heart rate
  • High blood pressure

Out of 204 patients, 5% of patients on SOMATULINE DEPOT and 3% of patients on placebo stopped treatment because of side effects that started during the study.

Side effects can vary from patient to patient. Not everyone will experience the same side effects or the same degree of severity. The most common side effects with 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.

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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
    • 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 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 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 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 professional.

You may report side effects to FDA at 1‑800‑FDA‑1088 or Ipsen Biopharmaceuticals, Inc. at 1‑888‑980‑2889.

Please click here for Patient Information and full Prescribing Information.

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Important Safety Information

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
    • 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 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 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 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 professional.

You may report side effects to FDA at 1‑800‑FDA‑1088 or Ipsen Biopharmaceuticals, Inc. at 1‑888‑980‑2889.

Please click here for Patient Information and full Prescribing Information.