Class: Biological Therapy

Generic Name: Lanreotide

Trade Name: Somatuline® Depot

For which conditions is this drug approved? Somatuline Depot is approved for:

• The long-term treatment of people with acromegaly, a hormonal disorder that develops when your pituitary gland produces too much growth hormone during adulthood. Somatuline Depot can be used in these patients when surgery or radiotherapy has not worked well enough or they are not able to have surgery or radiotherapy.
• The treatment of people with a type of cancer known as neuroendocrine tumors of the gastrointestinal tract or the pancreas that has spread or cannot be removed by surgery.

What is the mechanism of action? The active ingredient in Somatuline Depot, lanreotide, is a manmade form of the hormone somatostatin. Somatuline Depot works in the body like somatostatin—it regulates endocrine and nervous system function by inhibiting the secretion of several other hormones such as growth hormone, insulin, and gastrin.

How is Somatuline Depot typically given (administered)? Somatuline Depot is given as an injection—every four weeks, in your doctor’s office.

How are patients typically monitored? While you’re taking Somatuline Depot, your doctor will monitor you for gallstones, low or high blood sugar (hypo- or hyperglycemia), and heart function.

What are the common (occur in 30% or more of patients) side effects of treatment with Somatuline Depot?

Among patients with acromegaly:

• Gastrointestinal disorders (diarrhea, abdominal pain, flatulence)
• Joint pain
• Headache

Among patients with neuroendocrine tumors of the gastrointestinal tract or the pancreas:

• Abdominal pain

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Somatuline Depot?

Among patients with acromegaly:

• Injection site reactions
• Liver problems
• Heart rate and rhythm disorders
• Anemia
• Weight loss

Among patients with neuroendocrine tumors of the gastrointestinal tract or the pancreas:

• Bone and joint pain
• Vomiting
• Headache
• Injection site reaction
• High blood sugar
• High blood pressure
• Gallstones

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Tell your doctor about all of your medical conditions, especially if you have:
  • Gallbladder problems
  • Diabetes
  • Thyroid problems
  • Heart problems
  • Kidney problems
  • Liver problems
• Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Somatuline Depot and certain other medicines can affect each other, causing serious side effects. Your dose of Somatuline Depot or your other medicines may need to be adjusted.
• Be especially sure to tell your healthcare professional if you take:
  • Insulin or other diabetes medicines
  • A cyclosporine (Gengraf®, Neoral®, or Sandimmune®)
  • A medicine called bromocriptine (Parlodel®, Cycloset®)
  • Medicines that lower your heart rate, such as beta blockers
• Keep a list of all the medications you take and show it to your healthcare professional any time you get a new medication.

Are there any special precautions patients should be aware of before starting treatment?

• Tell your doctor if you are pregnant or plan to become pregnant. Somatuline Depot may harm your unborn baby.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Somatuline Depot will pass into your breast milk. You and your healthcare provider should decide if you will take Somatuline Depot or breastfeed—you should not do both.
• Somatuline Depot may cause dizziness. If this happens, do not drive a car or operate
machinery.

When should patients notify their physician?

• Tell your doctor if you have any side effects that bother you or don’t go away.
• Be especially sure to tell your doctor if you experience:
  • 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

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.