Somatuline Depot (lanreotide) is a man-made protein similar to a hormone in the body called somatostatin. Lanreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.

Somatuline Depo is used in adults to treat:

• acromegaly that cannot be treated with surgery or radiation;

• carcinoid syndrome; or

• a certain type of pancreatic or digestive tract tumor that may spread to other parts of the body.

Somatuline Depo is sometimes given after other treatments have failed.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Especially tell your healthcare provider if you take:

• insulin or other diabetes medicines

• cyclosporine (Gengraf, Neoral, or Sandimmune)

• medicines that lower your heart rate such as beta blockers

Somatuline Depo is injected under the skin.

A healthcare provider will give you this injection.

Somatuline Depo is usually given once every 4 weeks. Your doctor may occasionally change how often you receive injections.

Call your doctor if your symptoms do not improve, or if they get worse.

Your blood sugar may need to be checked often, and you may need other blood tests at your doctor's office.

Usual Adult Dose for Acromegaly:

Initial dose: 90 mg, by deep subcutaneous injection, every 4 weeks for 3 months

Comments:
-The goal of treatment is to reduce growth hormone (GH) and insulin-like growth factor (IGF-1) levels to normal.
-Adjust dose after initial 3 months.
-No dose adjustment is required for elderly patients.

Use: Long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

Usual Adult Dose for Neuroendocrine Carcinoma:

120 mg, by deep subcutaneous injection, every 4 weeks

Comments: No dose adjustment is required for elderly patients.

Use: Treatment of patients with unresectable, well or moderately-differentiated, locally advanced, or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

Usual Adult Dose for Carcinoid Syndrome:

120 mg by deep subcutaneous injection every 4 weeks

Comments: If patients are already being treated for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome.

Use: For the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

You should not use Somatuline Depo if you are allergic to lanreotide.

To make sure Somatuline Depot is safe for you, tell your doctor if you have ever had:

• gallbladder disease;

• diabetes (your diabetes medicine may need to be adjusted);

• liver or kidney disease;

• heart disease; or

• a thyroid disorder.

It is not known whether lanreotide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Somatuline Depo may affect fertility (your ability to have children) in women.

You should not breast-feed while using Somatuline Depo and for at least 6 months after your last dose.

Call your doctor for instructions if you miss an appointment for your Somatuline Depo injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Somatuline Depot: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain, slow heartbeats;

• shortness of breath;

• a light-headed feeling, like you might pass out;

• confusion, memory problems;

• feeling very weak or tired;

• a light-headed feeling, like you might pass out;

• low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• underactive thyroid symptoms - tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures; or

• signs of a gallbladder problem - sudden severe pain in your upper stomach spreading to your back or shoulder (may occur after meals or at night), nausea, fever, chills, yellowing of the skin or eyes.

Common Somatuline Depot side effects may include:

• headache, pounding in your neck or ears;

• dizziness;

• nausea, vomiting, diarrhea, stomach pain;

• muscle or joint pain;

• headache, dizziness; or

• pain, itching, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

When you start or stop taking Somatuline Depo, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Tell your doctor about all your other medicines, especially:

• bromocriptine;

• cyclosporine;

• insulin or oral diabetes medicine; or

• beta-blocker heart or blood pressure medicine (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others).

This list is not complete. Other drugs may interact with lanreotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.