Somatuline Depot 60 mg/0.2 mL subcutaneous syringe

Generic name:
Lanreotide depot - injection

Pronunciation
(lan-REE-oh-tide)

Brand name(s)
Somatuline

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 if available from your pharmacist before you start using lanreotide and before each monthly injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin by a health care professional. It is given as directed by your doctor, usually once every 4 weeks. The injection is given in the buttocks. 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. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Headache, muscle/joint pain, dizziness, nausea, vomiting, diarrhea, constipation, stomach upset, gas, or bloating may occur. Pain and irritation at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 (such as fever, stomach/abdominal pain, severe nausea/vomiting, yellowing eyes/skin, unexplained pain in the back/right shoulder)
• signs of an underactive thyroid (such as unexplained weight gain, cold intolerance, severe constipation, unusual/extreme tiredness, growth/lump/swelling on the front of the neck)
• slow heartbeat
• mental/mood changes (such as depression)
• weight loss
• change in stool color

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 (such as slow heartbeat, high blood pressure, heart valve problems)
• thyroid problems
• gallbladder problems (such as 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).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 breastfeeding.

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.

A product that may interact with this drug is:

• 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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as growth hormone levels, blood glucose tests, thyroid function, blood pressure, heart rate) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

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

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.