SOMATULINE DEPOT HELPS LOWER CERTAIN HORMONES RELATED TO ACROMEGALY

What is Somatuline Depot?

Somatuline Depot is a type of medication called a somatostatin analog, or SSA. After surgery and/or radiation, SSAs are a medication doctors use to treat acromegaly. Somatuline Depot is thought to work by reducing the growth hormone (GH) production in your body. When there is less GH in your body, your liver produces less insulin-like growth factor 1 (IGF-1).

A somatostatin analog like Somatuline Depot works directly on the pituitary adenoma to reduce excessive growth hormones.

Starting treatment: What to expect

Once you begin treatment with Somatuline Depot, you may not see or feel any immediate changes. Remember, Somatuline Depot works by lowering the hormone levels in your body, so you might not know if it is working.

How did Somatuline Depot perform in clinical trials?

In studies of patients with acromegaly for whom surgery or radiotherapy did not work well enough or was not an option, Somatuline Depot lowered levels of GH and IGF-1. Your doctor may adjust your dosing or the time between injections based on your response to treatment.

Your doctor can adjust your dose of Somatuline Depot based on your response

Once you are controlled on your starting dose of 90 mg every 4 weeks for 3 months, the dose may then be adjusted, depending on your GH and IGF-1 levels and symptoms. If you are controlled* on 90 mg once every 4 weeks, then you may be considered for an extended dosing interval of Somatuline Depot 120 mg once every 6 or 8 weeks. By changing the dosing interval to once every 6 or 8 weeks, less frequent injections would be needed over the year. Your doctor will continue to monitor your response and adjust the dose as needed.

Controlled patients may have the opportunity to have fewer injections a year

This chart explains how many Somatuline Depot injections are typically taken by patients per year for controlling acromegaly.

*Controlled is defined as GH level from >1.0 ng/mL to ≤2.5 ng/mL, normalized IGF-1 level, and satisfactory management of clinical symptoms as determined by the healthcare provider.

How Somatuline Depot is administered

Somatuline Depot should be administered by a healthcare professional every 4 weeks.

Somatuline Depot comes in a sterile, prefilled syringe. It 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 from one injection of Somatuline Depot to the next.
  • During your treatment, your healthcare professional may do certain blood tests to see if Somatuline Depot is working.

In addition, Safe 'n' Sound syringe technology provides

  • Prefilled, low-volume syringe, which helps support full delivery of your dose
  • Transparent design
  • Retractable needle that engages automatically
  • Manufacturing process using no latex or natural dry rubber
  • Reinforced plunger design

Options of how to get your injections

  • In the doctor’s office

  • At home, via Home Health Administration, arranged through the IPSEN CARES® program; the cost is covered by Ipsen for eligible patients

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Important Safety Information and Indication

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 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.

What is Somatuline® Depot (lanreotide) Injection?

Somatuline Depot is a prescription medicine used 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.

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

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

Click here for Patient Information and Full Prescribing Information.

Somatuline Depot is available in 60, 90, and 120 mg

Indication

What is Somatuline® Depot (lanreotide) Injection?

Somatuline Depot is a prescription medicine used 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.

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This is an illustration of Somatuline Depot injection. It explains how the injection is administered for acromegaly patients.

Device not shown at actual size

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