Somatuline Depot

Somatuline Depot is used to treat acromegaly, a condition in adults in which the pituitary gland makes too much growth hormone leading to overgrowth of certain parts of the body, such as the face and hands. Somatuline Depot can also be used for certain gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In addition, Somatuline Depot is used to treat carcinoid syndrome, which occurs when a rare cancerous tumor called a neuroendocrine tumor secretes certain chemicals into your bloodstream, causing signs and symptoms.

Somatuline Depot behaves like somatostatin, a natural hormone that helps control many functions in different parts of the body, which includes stopping the pituitary gland from secreting growth hormone.

Somatuline Depot is injected deep under the skin in the buttock, typically once every 4 weeks for 3 months. After 3 months the dosage may be adjusted.

Common side effects include diarrhea, gallstones, and stomach pains.

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

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

It is also approved for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. 

In addition, Somatuline Depot is used to treat adults with carcinoid syndrome, to reduce the frequency of short-acting somatostatin analog rescue therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Ipsen Biopharmaceuticals, Inc.

The most common side effects include:

When treating acromegaly:

• diarrhea
• gallstones
• stomach area (abdominal) pain
• nausea
• pain, itching or a lump at the injection site

When treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs):

• stomach area (abdominal) pain 
• muscle or skeletal (bone) pain
• vomiting
• headache
• pain, itching or a lump at the injection site
• high blood sugar
• high blood pressure
• gallstones

When treating carcinoid syndrome:

• headache
• dizziness
• muscle spasm

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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• insulin or other diabetes medicines
• a cyclosporine (Gengraf, Neoral, or Sandimmune)
• a medicine called bromocriptine (Parlodel)
• medicines that lower your heart rate such as beta blockers

This is not a complete list of Somatuline Depot drug interactions. Ask your doctor or pharmacist for more information.

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 injections or if your dose changes.
• slow heart rate
• high blood pressure

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Somatuline Depot, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you receive Somatuline Depot, tell your doctor if you have:

• gallbladder problems
• diabetes
• thyroid problems 
• heart problems
• kidney problems
• liver problems
• are allergic to latex or natural dry rubber. The pre-filled syringe needle cover contains rubber.
• are pregnant or plan to become pregnant. It is not known if Somatuline Depot will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed. It is not known if Somatuline passes into your breast milk. Talk to your doctor about the best way to feed your baby if you receive this medication. 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Somatuline Depot falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Somatuline crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Somatuline Depot.

• You will receive an injection every 4 weeks as directed by your doctor. Your doctor may change your dose or the length of time between your 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.
• During your treatment, your doctor may do certain blood tests to see if Somatuline Depot is working. Your doctor may change your dose, or length between your injections as needed.

Acromegaly:

Patients should begin treatment with Somatuline Depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months.

After 3 months dosage may be adjusted.

GEP-NET (gastroenteropancreatic neuroendocrine tumors):

The recommended dose and schedule for Somatuline Depot is 120 mg administered by deep subcutaneous injection every 28 days. 

Carcinoid Syndrome: 

The recommended dose and schedule for Somatuline Depot is 120 mg administered by deep subcutaneous injection every 28 days.  

Somatuline Depot is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.