Lanreotide Injection

WHY is this medicine prescribed?

Lanreotide injection is used to treat people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who have not successfully, or cannot be treated with surgery or radiation. Lanreotide injection is also used to treat people with neuroendocrine tumors in the gastrointestinal (GI) tract or the pancreas (GEP-NETs) that have spread or cannot be removed by surgery. It is also used to treat carcinoid syndrome (a condition in which slow-growing tumors release natural substances that can cause symptoms such as diarrhea and flushing) in people who have been successfully treated with short-acting injections but prefer to receive injections less often. Lanreotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of certain natural substances produced by the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lanreotide comes as a long-acting solution (liquid) to be injected subcutaneously (under the skin) into the upper outer area of your buttock by a doctor or nurse. Lanreotide long-acting injection is usually injected once every 4 weeks.

Your doctor may adjust your dose or the length of time between doses depending on your response to treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving lanreotide injection,

• tell your doctor and pharmacist if you are allergic to lanreotide injection, any other medications, or any of the ingredients in lanreotide injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving lanreotide injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had high blood pressure; high or low blood sugar; diabetes; or gallbladder, pancreas, heart, kidney, thyroid, or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while receiving lanreotide injection, call your doctor.

• tell your doctor if you are breastfeeding or plan to breast feed. Do not breastfeed during your treatment and for 6 months after your last dose.

• you should know that lanreotide injection may decrease fertility in women. Talk to your doctor about the risks of receiving lanreotide injection.

• you should know that lanreotide injection may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of lanreotide injection, call your doctor to reschedule the appointment.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of high and low blood sugar and what to do if you have these symptoms.

Lanreotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• gas
• vomiting
• headache
• redness, pain, itching, or a lump at the injection site
• muscle or joint pain or discomfort

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• pain in the upper right part of the stomach, center of the stomach, back, or shoulder; yellowing of the skin or eyes; fever with chills; or nausea
• loose, fatty, or light-colored stools; stomach bloating; or weight loss
• sluggishness, sensitivity to cold, pale or dry skin, thin or brittle hair, puffy face, weight gain, constipation, decreased sweating, or depression
• swelling of the face, throat, tongue, lips, or eyes
• tightness in the throat
• difficulty breathing and swallowing
• wheezing
• hoarseness
• rash
• itching
• hives
• shortness of breath
• slowed or irregular heartbeat, dizziness, lightheadedness, fainting, chest pain, extreme tiredness, confusion

Lanreotide injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

If you are storing the prefilled syringes in your home until it is time for it to be injected by your doctor or nurse, you should always store it in original carton in the refrigerator and protect it from light. Throw away any medication that is outdated or no longer needed. Talk to your healthcare provider about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lanreotide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.