Lixisenatide, Injection

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KEY POINTS

• This medicine is given by injection to treat type 2 diabetes. Use it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic; GLP-1 receptor agonist

Generic and brand names: lixisenatide, injection; Adlyxin

What is this medicine used for?

This medicine is given by injection (shots) along with diet and exercise to treat type 2 diabetes. It is used along with other diabetes medicines. This medicine is not used to treat type 1 diabetes or diabetic ketoacidosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetic ketoacidosis
• Gallstones
• Gastroparesis (slow stomach emptying) or problems digesting food
• Kidney problems
• Pancreatitis
• Problems with alcohol abuse

Tell your healthcare provider if you have recently had surgery, an infection, or a fever. Tell your provider if you get sick or injured, or if you are scheduled to have surgery. Your medicine dose may need to be adjusted.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is injected once a day, 1 hour before your first meal of the day. Use it at about the same time each day. This medicine should not be mixed with insulin injections. You may give the separate injections of this medicine and insulin in the same area of the body, such as the stomach, but do not give the injections right next to each other. Talk with your healthcare provider for specific instructions. Do not stop taking this medicine without your healthcare provider's approval.

This medicine comes in a prefilled pen. Check the label on the medicine for directions about your specific dose. Carefully select the correct dose on the pen. Use only needles that are approved for use with the Adlyxin prefilled pen. Talk with your healthcare provider or pharmacist about this.

Be sure you know when to take the medicine and how much medicine you should take. Your provider will teach you how to use this medicine. Carefully follow the instructions included in the medicine package for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Do not use this medicine if the liquid in the pen looks cloudy or has changed color. Never share needles, pens, or delivery devices with anyone else.

What if I miss a dose?

If you miss a dose, take it as soon as you remember on the same day within 1 hour before a meal. Take the next day’s dose at your usual time. Do not take double doses. If you are not sure of what to do if you miss a dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe nausea, vomiting, diarrhea.

What should I watch out for?

Follow the diet and exercise program prescribed by your healthcare provider. Eat regular meals and do not skip meals, even when you travel or are sick.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Alcohol may affect your response to medicine and food. Do not drink alcohol unless your healthcare provider approves.

This medicine may cause pancreatitis, which can be life-threatening. If you have sudden and severe stomach pain, or back pain, with or without vomiting, contact your healthcare provider right away.

This medicine may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). When you lose a lot of fluid, you need to drink more to replace what you have lost. Ask your healthcare provider how much liquid you should drink while taking this medicine.

When used alone, this medicine may not cause hypoglycemia (low blood sugar). However, when used with insulin or other diabetes medicines, hypoglycemia can happen and may be serious. Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, use too much of this medicine or too much insulin, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report this to your healthcare provider if these symptoms happen often): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); severe or constant nausea or vomiting; severe stomach or back pain; severe diarrhea; urinating more often, less often, or not at all; dark urine.

Other: Indigestion, headache, diarrhea, constipation, dizziness mild stomach pain, injection site itching or pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Other diabetes medicines such as alogliptin (Nesina), alogliptin/metformin (Kazano), canagliflozin/metformin (Invokamet), chlorpropamide, dapagliflozin/metformin (Xigduo), empagliflozin (Jardiance), glimepiride (Amaryl), glipizide (Glucotrol), glipizide/metformin, glyburide (Glynase), insulin, linagliptin (Tradjenta), linagliptin/metformin (Jentadueto), metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone/metformin (Actoplus Met), repaglinide (Prandin), repaglinide/metformin (PrandiMet), rosiglitazone/metformin (Avandamet), saxagliptin (Onglyza), saxagliptin/metformin (Kombiglyze), sitagliptin (Januvia), sitagliptin/metformin (Janumet), and tolbutamide

This medicine slows stomach emptying and can affect other medicines you take. You may need to take other medicines several hours apart from when you take this medicine. Talk with your healthcare provider about this if you are taking ANY other medicines.

Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Before you use the pen for the first time, store this medicine in the refrigerator. Do not let it freeze. Let the pen warm to room temperature before giving an injection.

After the first use, store the injection pen at room temperature for 14 days. Remove and discard the needle after each injection, and store the pen without a needle attached. Protect it from heat, high humidity, and bright light. Throw away the pen after 14 days, even if there is some medicine left in the pen.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.