Somatuline Depot

This medication is a long-acting form of lanreotide. Lanreotide is used to treat a condition called acromegaly that occurs when the body makes too much of a certain natural substance called growth hormone. It is used when surgery or radiation treatment have not been fully successful or cannot be used. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Lanreotide works by decreasing the amount of growth hormone to normal levels.

This drug is not a cure for acromegaly. It is used for the long-term treatment of this condition.

This medication is also used to treat certain cancer or tumors of the stomach, intestines, or pancreas. It may help to slow down the growth of these tumors. Lanreotide is also used to treat carcinoid syndrome. It may help reduce the need to use another medication to treat diarrhea or flushing caused by carcinoid syndrome.

Read the Patient Information Leaflet provided by your doctor or pharmacist before you start using lanreotide and before each monthly injection since there may be new information. If you have any questions, consult your doctor or pharmacist.

This medication is given by injection deep under the skin of your buttock by a health care professional as directed by your doctor, usually once every 4 weeks. To reduce irritation from the injection, your doctor will alternate between the left and right buttock with each dose. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder (e.g., every 4 weeks).

Tell your doctor if your condition does not improve or if it worsens.

Headache, muscle/joint pain, dizziness, nausea, vomiting, loose stools, diarrhea, constipation, stomach upset, gas, or weight loss may occur. Pain and irritation at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of gallbladder problems/gallstones (e.g., fever, stomach/abdominal pain, severe nausea/vomiting, yellowing eyes/skin, unexplained pain in the back/right shoulder), signs of an underactive thyroid (e.g., unexplained weight gain, cold intolerance, severe constipation, unusual/extreme tiredness, growth/lump/swelling on the front of the neck), slow heartbeat, mental/mood changes (e.g., depression).

This medication may rarely cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger. Tell your doctor right away if you experience symptoms of high or low blood sugar while using this medication. Monitor your blood sugar levels as directed by your doctor. Your doctor may need to adjust your diabetes medications.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using lanreotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex found in the packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, diabetes, heart problems (e.g., slow heartbeat, high blood pressure, heart valve problems), thyroid problems, gallbladder problems (e.g., gallstones).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a clinic and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: beta blockers (e.g., metoprolol, propranolol), pegvisomant.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Laboratory and/or medical tests (e.g., growth hormone levels, blood glucose tests, thyroid function tests, blood pressure, heart rate) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.