ABOUT SOMATULINE DEPOT
How Can it Help?

SOMATULINE^® DEPOT IS PROVEN TO HELP PATIENTS WITH GEP-NETs IN TWO IMPORTANT WAYS

Slowed the growth of GEP‑NETs in patients whose disease has spread or cannot be removed by surgery

Time to disease progression or death in a clinical study

Cancer progression or death in a clinical study

IN A CLINICAL STUDY, SOMATULINE DEPOT REDUCED THE RISK OF DISEASE PROGRESSION OR DEATH BY 53% VERSUS PLACEBO

AT 22 MONTHS, CANCER DID NOT PROGRESS IN MORE THAN HALF OF PATIENTS TAKING SOMATULINE DEPOT (EVENTS OCCURRED IN 32 OUT OF 101 PATIENTS [31.7%] VERSUS 60 OUT OF 103 PATIENTS [58.3%] WITH PLACEBO)

FOR THOSE TAKING PLACEBO, IT TOOK 16.6 MONTHS UNTIL CANCER PROGRESSED IN HALF OF PATIENTS

About the study

Somatuline Depot was studied for nearly 2 years in 204 adult patients with various types of GEP-NETs that had spread or could not be removed by surgery. In some patients, the cancer started in their pancreas. In others, it started in a different place, such as their intestinal tract, which includes the colon.

Patients in the study were divided into two groups, which received either Somatuline Depot 120 mg or placebo by deep subcutaneous injection every 4 weeks. The primary goal of this study was to determine if Somatuline Depot improved progression-free survival, which is the amount of time it took for the disease to progress.

*Assessed by a central independent radiological review in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Reduced the number of rescue medication days for carcinoid syndrome

SOMATULINE DEPOT HELPED REDUCE THE NUMBER OF DAYS OF RESCUE MEDICATION PATIENTS MAY NEED

Rescue medications are short-acting medicines used to lessen symptoms of carcinoid syndrome, including diarrhea and flushing.

In other words, patients on Somatuline Depot experienced 15% fewer days on rescue medication compared to patients on placebo (34% of days on rescue medication for patients on Somatuline Depot versus 49% of days on rescue medication for patients on placebo).

With Somatuline Depot, patients experienced approximately 4.4 fewer days of rescue therapy per month, or around 53 fewer days per year.

FDA-approved to treat adults with carcinoid syndrome to reduce the need to use short-acting somatostatin medicine

About the study

Somatuline Depot was studied for 16 weeks in 115 patients with confirmed NETs and a history of carcinoid syndrome (flushing and/or diarrhea) to reduce the need for short-acting somatostatin medicine.

Patients were divided into two groups, which received either Somatuline Depot 120 mg or placebo by deep subcutaneous injection every 4 weeks. Many patients were living with carcinoid syndrome as a result of being diagnosed with NETs for less than a year before starting treatment.

IMPORTANT SAFETY INFORMATION & INDICATIONS

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

SOMATULINE DEPOT may cause serious side effects, including:

Gallstones
Changes to your blood sugar (high or low blood sugar),
Slow heart rate, and
High blood pressure.

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.
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 near-fainting, chest pain, shortness of breath, confusion or memory problems, and weakness or extreme tiredness.

The most common side effects of SOMATULINE DEPOT in people with:

GEP-NETs: stomach area (abdominal) pain; muscle and joint aches; vomiting; headache; pain, itching or a lump at the injection site
Carcinoid syndrome: headache, dizziness, muscle spasm; side effects were generally similar to those commonly seen with GEP‑NETs

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 treatment of a type of cancer known as neuroendocrine tumors, from the gastrointestinal tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery; and

the treatment of carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine.

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

SOMATULINE® DEPOT IS PROVEN TO HELP PATIENTS WITH GEP-NETs IN TWO IMPORTANT WAYS