Lixisenatide Injection

WHY is this medicine prescribed?

Lixisenatide injection is used along with diet and exercise to treat type 2 diabetes (condition in which the body does not use insulin normally and cannot control the amount of sugar in the blood). Lixisenatide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Lixisenatide injection also slows the emptying of the stomach and causes a decrease in appetite.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

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?

Lixisenatide injection comes as a prefilled dosing pen to inject subcutaneously (under the skin). It is injected once a day, within 1 hour (60 minutes) before the first meal of the day. Use lixisenatide injection at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lixisenatide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of lixisenatide and then increase your dose after 14 days.

Lixisenatide injection controls diabetes but does not cure it. Continue to use lixisenatide injection even if you feel well. Do not stop using lixisenatide injection without talking to your doctor.

You will be shown how to use the injection pen by your doctor or nurse. You will also be given instructions for use with the medicine. This will tell you how to inject it. Read it carefully. Ask your doctor or pharmacist if you have any questions on how to inject the medicine.

You will need to buy needles separately. Ask your doctor or pharmacist what type of needles you will need to inject your medication.

Always look at the lixisenatide solution before you inject it. It should be clear, colorless, and free of particles. Do not use lixisenatide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the pen has passed.

Lixisenatide injection can be administered in the thigh (upper leg), abdomen (stomach area), or upper arm. Use a different site for each injection. Allow the pen to warm to room temperature before using it if stored in the refrigerator.

Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Throw away needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

What SPECIAL PRECAUTIONS should I follow?

Before taking lixisenatide injection,

• tell your doctor and pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

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

• If you are taking oral contraceptives (birth control pills) take them at least 1 hour before, or 11 hours after using lixisenatide injection.

• tell your doctor if you have or have ever had severe stomach problems, including gastroparesis (slowed movement of food from the stomach to the small intestine), or problems digesting food; pancreatitis (swelling of the pancreas) or problems with your pancreas.

• This medication may cause changes in your blood sugar. Signs and symptoms of low bloodsugar may include dizziness or lightheadedness, irritability, sweating, hunger, confusion or drowsiness, shakiness, weakness, headache, slurred speech, blurred vision, fast heart rate and feeling jittery. You should knowthe symptoms of low blood sugar and what to do if you have these symptoms.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lixisenatide injection, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using lixisenatide injection.

• ask your doctor what to do if there is a large change in your diet, exercise, or weight; or if you get sick, develop an infection or fever, experience unusual stress, or are injured. These changes and conditions can affect your blood sugar and the amount of lixisenatide injection you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet.

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

Inject the missed dose within 1 hour (60 minutes) before your next meal. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

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

• nausea, vomiting, diarrhea
• constipation
• indigestion
• bloating
• headache
• pain, itching, or redness at the injection site

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

• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, with or without vomiting
• hives, rash, itching
• pounding heartbeat
• fainting or feeling dizzy
• swelling of the eyes, face, mouth, tongue, throat, feet, ankles, or lower legs
• difficulty swallowing or breathing
• hoarseness
• decreased urination,
• very dry mouth or skin or extreme thirst
• severe stomach problems

Lixisenatide injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it away from light, heat, dust and dirt. Store unused lixisenatide pens in the refrigerator (36°F to 46°F [2°C to 8°C]). Once a lixisenatide pen is in use, store it at room temperature (below 86°F [30°C]) with its cap on. Do not freeze. Do not use lixisenatide if it has been frozen. Dispose of lixisenatide pens in a puncture-resistant container after 14 days from its first use, even if there is some solution left in the pen.

When traveling, be sure to keep lixisenatide pens dry. Unused pens should be refrigerated or kept at a cold temperature between 36°F to 46°F (2°C to 8°C). Pens that are in use can be stored at room temperature up to 86°F [30°C] (not in a car glove compartment or other hot place).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

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.

Symptoms of overdose may include the following:

• nausea
• vomiting
• diarrhea
• abdominal pain or bloating
• indigestion
• constipation

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to lixisenatide injection. Your doctor will tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

Do not let anyone else take 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.