Click here for updated information about the Somatuline® Depot device
somatuline depot logo Somatuline Depot full Prescribing Information

Ipsen is pleased to announce that the US Food and Drug Administration (FDA) has approved a new device to deliver Somatuline® Depot to patients with acromegaly. The enhanced device with Safe’n’Sound® syringe technology will continue to offer a streamlined injection process with its prefilled, low-volume syringe that supports full delivery of your dose and is ready to use without mixing.

The syringe is available in 60-mg, 90-mg, and 120-mg doses and will offer several additional benefits:

The updated design has been available in the European Union since January 2012 and will be available in the US beginning January 2015.

Click here for Important Saftey Information about Somatuline Depot.

This new device incorporating Safe’n’Sound® syringe technology should be administered by a healthcare professional.

Ipsen is continually looking for ways to improve delivery of the medications that are critical to your care. The enhanced device is one example of this commitment.

Please click here for additional information about the Somatuline Depot device.

To read the Ipsen Press Release, please click here.

Somatuline® Depot—A Long-Term Treatment for Your Journey With Acromegaly

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.

A Diagnosis of Acromegaly—the First Step Toward Moving Forward

A Diagnosis of Acromegaly

It may have begun with a variety of seemingly disconnected symptoms: enlarged tongue, nose, or lips; headaches; or excessive sweating. Over time you may have noticed abnormal bone growth or enlargement in your face, hands, or feet; your joints aching; abnormal weight gain; prognathism (an enlargement of the lower jaw); or sleep apnea.

After a great deal of frustration over a lack of answers, you may have finally been diagnosed with acromegaly, a rare condition that is usually due to the pituitary gland located at the base of the brain releasing too much growth hormone (GH) into the bloodstream.

Being diagnosed with acromegaly can be disconcerting and confusing. It can also be an important step toward managing your disease with proper treatment—and moving forward with acromegaly.

Our website is here to help you gain a better understanding of:

You’ll also find helpful resources for speaking to your doctor about treatment and insightful videos of other people with acromegaly currently living with and treating their disease.

Although acromegaly can’t always be cured, it can often be managed with proper treatment. Somatuline Depot (lanreotide) Injection is a long-term acromegaly therapy that offers proven reduction of GH and insulin-like growth factor 1 (IGF-1), the hormones that are elevated in acromegaly.

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.

Important Safety Information

Somatuline Depot may cause serious side effects including:

  • Gallstones
  • Changes in your blood sugar (high blood sugar or low blood sugar)
  • Slow heart rate
  • High blood pressure

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

These are not all the possible side effects of Somatuline Depot. Tell your doctor if you have any side effect that bothers you or that does not go away.

Before you receive Somatuline Depot, talk to your doctor about:

All of your medical conditions, including:

  • Gallbladder, thyroid, heart, kidney, or liver problems
  • Diabetes
  • Allergy to latex or natural dry rubber
  • Pregnancy or plans to become pregnant
    • It is not known if Somatuline Depot could harm your unborn baby
  • Breast-feeding or plans to breast-feed
    • It is not known if Somatuline Depot passes into breast milk

Any medicines (prescription and nonprescription) you are taking, including:

  • Insulin or other diabetes medicines
  • A cyclosporine (such as Gengraf™, Neoral®, or Sandimmune®)
  • A medicine called bromocriptine (such as Parlodel®)
  • Medicines that lower your heart rate (such as beta blockers)

While on Somatuline Depot:

  • Tell your doctor if you have sudden pain in your upper right stomach (abdominal) area or in your right shoulder or between your shoulder blades, or if you have yellowing of your skin and whites of your eyes, fever with chills, or nausea as these could be symptoms related to gallstones
  • 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
  • Before each treatment, read the Patient Information that comes with each Somatuline Depot package as there may be new information. Talk with your doctor about your medical condition or your treatment. Your doctor is your primary source of information about treatment

Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: at www.fda.gov/medwatch or call 1-800-FDA-1088. 

Click here for Patient Information and Full Prescribing Information.

SOMATULINE DEPOT is a registered trademark of Ipsen Pharma S.A.S.
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© 2014 Ipsen Biopharmaceuticals, Inc.

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