ABOUT SOMATULINE® DEPOT

SUSTAINED CONTROL MAY BE POSSIBLE^a

^a”Control” means that GH levels are within a healthy range, IGF-1 levels are normal and symptoms are under control, based on your healthcare provider’s assessment.

Actor portrayal

SUSTAINED CONTROL may be POSSIBLE^a

^a”Control” means that GH levels are within a healthy range, IGF-1 levels are normal and symptoms are under control, based on your healthcare provider’s assessment.

What is Somatuline® Depot (lanreotide) injection?

Somatuline Depot is a type of medication called a somatostatin analog (or SSA). Somatuline Depot may be used when surgery or radiotherapy haven’t worked well enough or aren’t an option.

How does Somatuline Depot work?

Somatuline Depot reduces the amount of growth hormone (or GH) that your body makes. When there is less GH in your body, your liver produces less insulin-like growth factor 1 (or IGF-1).

How was Somatuline Depot proven to work?

In a clinical study, Somatuline Depot lowered GH and IGF-1 levels in 108 people with acromegaly.

At 4 weeks of treatment from baseline^b:

63% (52/83)
had >50% reduction in GH

25% (21/83)
had normalized IGF-1 levels

Additional data at 1 year of treatment from baseline^b:

82% of patients (68 out of 83) had normal GH
59% of patients (49 out of 83) had normal IGF-1

Remember, Somatuline Depot works by reducing hormone levels in your body. This may take time, and you may not see or feel any immediate changes. Be sure to check with your doctor about monitoring your levels.

Adverse reactions in more than 5% of patients who received SOMATULINE DEPOT were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), and injection-site reactions (9%).

If you experience any of these side effects or any other side effects associated with Somatuline Depot, talk to your medical team right away.

^bThe primary purpose of the study was to assess GH levels at Week 4; however, the study also assessed IGF-1 levels at Week 4 and GH and IGF-1 levels at Week 52.

See the full Somatuline Depot story

Download the Patient Education Brochure to learn more about acromegaly, Somatuline Depot, and IPSEN CARES®.

Download

What should I know before taking Somatuline Depot?

The most common side effects of Somatuline Depot in people with acromegaly include diarrhea; stomach (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.

Before taking Somatuline Depot, tell your healthcare provider (or HCP) about all of your medical conditions including if you: have diabetes; have gallbladder, heart, thyroid, kidney or liver problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if Somatuline Depot will harm your unborn baby or pass into breast milk. You should not breastfeed if you receive Somatuline Depot and for 6 months after your last dose. Somatuline Depot may affect your ability to become pregnant.

Tell your HCP about all of 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. Your dose of Somatuline Depot or your other medications may need to be changed. If you have diabetes, your HCP may change your dose of diabetes medication when you first start receiving Somatuline Depot or if your dose of Somatuline Depot is changed.

Especially tell your HCP if you take:

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

Know the medicines you take. Keep a list of them to show your HCP when you get a new medicine.

Tell your HCP 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 HCP.

Learn how Somatuline Depot is taken

IMPORTANT SAFETY INFORMATION & INDICATION

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

SOMATULINE DEPOT may cause serious side effects, including:

Gallstones

Fatty stool

Changes to your blood sugar (high or low blood sugar),

Slow heart rate,

High blood pressure, and

Changes in thyroid function in acromegaly patients.

Tell your healthcare provider (HCP) if you have any of the following symptoms:

Symptoms of gallstones may include 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, and nausea.

Fatty stool. SOMATULINE DEPOT may cause your body to have issues absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating or weight loss.

Symptoms of high blood sugar may include increased thirst, increased appetite, nausea, weakness or tiredness, urinating more than normal, and fruity smelling breath.

Symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, irritability or mood changes, and hunger.

Symptoms of slow heart rate may include dizziness or lightheadedness, fainting or nearfainting, chest pain, shortness of breath, confusion or memory problems, and weakness or extreme tiredness.

SOMATULINE DEPOT can cause the thyroid gland to not make enough thyroid hormone in people with acromegaly. Symptoms of low thyroid levels may include fatigue,
weight gain, puffy face, being cold all the time, constipation, dry skin, thinning or dry hair, decreased sweating, and depression.

The most common side effects of SOMATULINE DEPOT in people with acromegaly include diarrhea; stomach (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.

Tell your HCP right away if you have signs of an allergic reaction after receiving SOMATULINE DEPOT, including swelling of your face, lips or tongue; breathing problems; fainting, dizziness or feeling lightheaded (low blood pressure); itching; skin flushing or redness; rash; or hives.

Before taking SOMATULINE DEPOT, tell your HCP about all your medical conditions including if you: have diabetes; have gallbladder, heart, thyroid, kidney or liver problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if SOMATULINE DEPOT will harm your unborn baby or pass into breast milk. You should not breastfeed if you receive SOMATULINE DEPOT and for 6 months after your last dose. SOMATULINE DEPOT may affect your ability to become pregnant.

Tell your HCP 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. Your dose of SOMATULINE DEPOT or your other medications may need to be changed. If you have diabetes, your HCP may change your dose of diabetes medication when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT is changed.

Especially tell your HCP if you take:

Insulin or other diabetes medicines,

A cyclosporine (Gengraf, Neoral, or Sandimmune), or

Medicines that lower your heart rate, such as beta blockers.

Know the medicines you take. Keep a list of them to show your HCP when you get a new medicine.

Tell your HCP 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 HCP.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at
1-855-463-5127 or FDA at 1-800-FDA-1088 or .

What is SOMATULINE® DEPOT (lanreotide) Injection?

SOMATULINE DEPOT is a prescription medicine used in adults for the long-term treatment of people with acromegaly when surgery or radiotherapy have not worked well enough or a patient is unable to have surgery or radiotherapy.

It is not known if SOMATULINE DEPOT is safe and effective in children.

SUSTAINED CONTROL MAY BE POSSIBLEa

a”Control” means that GH levels are within a healthy range, IGF-1 levels are normal and symptoms are under control, based on your healthcare provider’s assessment.